Diagnostics Makers Encouraged to Help Fight Antimicrobial Resistance

Posted in IVD by Daphne.Allen on June 26, 2017

Education and additional rapid diagnostics are needed to help save lives, say advocates.

Daphne Allen

Deaths from antimicrobial resistance (AMR) could reach 10 million annually by 2050, fears a new industry alliance. Diagnostics manufacturers (along with those developing pharmaceutical and biotechnology products) have an important role to play in combating AMR, and these industries have formed an alliance to support such work.

Antibiotics may be losing their effectiveness faster than newer ones are being introduced, reported the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) last year as these industries came together at the World Economic Forum in Davos in 2016 to begin formulating an action plan.

The AMR Industry Alliance officially kicked off this May, when IFPMA Director-General Thomas Cueni announced its launch at the B20 Health Conference in Berlin. “It is estimated that, unless action is taken, the burden of deaths from antimicrobial resistance could be as high as 10 million lives each year by 2050 – more than cancer,” claimed the alliance in a May 17 news statement marking the launch. 

AdvaMedDx joined the alliance as a board member to raise awareness about diagnostics along with bioMerieux and Labcorp. “Diagnostics play a critical role in any strategy to fight AMR,” Tharini Sathiamoorthy, the Vice President of AdvaMedDx, told Qmed. “Diagnostics can help distinguish between infections that require antibiotic treatment and those that do not.”

The challenge is that diagnostics are often overlooked, she said. “Rapid diagnostic tests are available,” she said, but “one issue we have is that healthcare providers don’t always know about them.”

In addition, “a number of tests are being underutilized primarily because of reimbursement issues,” she added. “There are few incentives to use them under private insurance or CMS. The economic piece on why they should be reimbursed should be improved.”

AdvaMedDx encourages diagnostics manufacturers to raise awareness of these issues and to focus on education. “Speak up and go to events and conferences with other stakeholders,” she advised. “Make sure discussions include diagnostics, particularly at the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria and the World Health Organization.”

There is also more work to be done in diagnostics development. “One test that is needed is a rapid diagnostic test to determine whether an infection is bacterial or viral,” Sathiamoorthy said.

AdvaMedDx is also embarking on its own separate initiative to fight AMR, a global commitment it announced in January 2017 to drive adoption of diagnostics tests, she added.

In the meantime, the AMR Alliance is developing a set of metrics to gauge progress since more than 100 companies and trade associations came together in Davos in 2016. A progress report is expected to be available in January 2018. The pharma industry also established its own roadmap for a common set of principles for global action that focus on reducing the development of antimicrobial resistance, investing in R&D to meet public health needs, and improving access to antibiotics, vaccines, and diagnostics.

[Image source: Evgeny Atamanenko/Shutterstock]

Daphne Allen is executive editor of Pharmaceutical & Medical Packaging News and a contributor to Qmed. Reach her at daphne.allen@ubm.com and on Twitter at @daphneallen

 

Drug-resistant ‘nightmare bacteria’ show worrisome ability to diversify and spread

For immediate release: Monday, January 16, 2017

Boston, MA – A family of highly drug-resistant and potentially deadly bacteria may be spreading more widely—and more stealthily—than previously thought, according to a new study from Harvard T.H. Chan School of Public Health and the Broad Institute of MIT and Harvard. 

Researchers examined carbapenem resistant Enterobacteriaceae (CRE) causing disease in four U.S. hospitals. They found a wide variety of CRE species. They also found a wide variety of genetic traits enabling CRE to resist antibiotics, and found that these traits are transferring easily among various CRE species. The findings suggest that CRE is more widespread than previously thought, that it may well be transmitting from person to person asymptomatically, and that genomic surveillance of this dangerous bacteria should be increased.

The study was published online January 16, 2017 in PNAS (Proceedings of the National Academy of Sciences)

“While the typical focus has been on treating sick patients with CRE-related infections, our new findings suggest that CRE is spreading beyond the obvious cases of disease. We need to look harder for this unobserved transmission within our communities and healthcare facilities if we want to stamp it out,” said William Hanage, associate professor of epidemiology at Harvard Chan School and senior author of the study.

CRE are a class of bacteria that is resistant to multiple antibiotics, including carbapenems, which are considered last-resort drugs when other antibiotics have failed. CRE, which tend to spread in hospitals and long-term care facilities, cause an estimated 9,300 infections and 600 deaths in the U.S. each year, according to the U.S. Centers for Disease Control and Prevention—and incidence is on the rise. CDC director Tom Frieden has called these ‘nightmare bacteria’ because they are resistant to some of the last-ditch treatments available to doctors battling resistant infections. 

The researchers looked at about 250 samples of CRE from hospitalized patients from three Boston-area hospitals and from one California hospital. Their goal was to obtain a snapshot of the genetic diversity of CRE, to define the frequency and characteristics of outbreaks, to find evidence of strains being transmitted within and between hospitals, and to learn how resistance is being spread among species. Previous studies have typically examined just one outbreak at a time.

Researchers found what Hanage termed a “riot of diversity,” both among CRE species and among carbapenem resistance genes. They also found that resistance genes are moving easily from species to species, contributing to a continually evolving threat from CRE.

In addition, the researchers found resistance mechanisms that hadn’t been seen before—implying that there are more to be discovered. The finding highlights the need for vigilance in searching for as yet unknown forms of resistance as they evolve and emerge. 

“The best way to stop CRE making people sick is to prevent transmission in the first place,” said Hanage. “If it is right that we are missing a lot of transmission, then only focusing on cases of disease is like playing Whack-a-Mole; we can be sure the bacteria will pop up again somewhere else.” 

Lead authors were Gustavo Cerqueira and Ashlee Earl of the Broad Institute of Harvard and MIT. Yonatan Grad, assistant professor of immunology and infectious diseases at Harvard Chan School, was a co-author of the study.

Funding for the study came from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272200900018C and Grant Number U19AI110818 to the Broad Institute. YHG was supported by K08AI104767 and JEK was supported by R21AI112694 and R21AI119114 from the NIH/NIAID. JLRC was supported by CAPES fellowship, process 99999.010768/2014-09. 

“Multi-institute analysis of carbapenem resistance reveals remarkable diversity, unexplained mechanisms and limited clonal outbreaks,” Gustavo C. Cerqueira, Ashlee M. Earl, Christoph M. Ernst, Yonatan H. Grad, John P. Dekker, Michael Feldgarden, Sinéad B. Chapman, João L. Reis-Cunha, Terrance P. Shea, Sarah K. Young, Qiandong Zeng, Mary L. Delaney, Diane Kim, Ellena M. Peterson, Thomas F. O’Brien, Mary J. Ferraro, David C. Hooper, Susan S. Huang, James E. Kirby, Andrew B. Onderdonk, Bruce W. Birren, Deborah T. Hung, Lisa A. Cosimi, Jennifer R. Wortman, Cheryl I. Murphy, William P. Hanage, PNAS, online January 16, 2017, doi: 10.1073/pnas.1616248114

Visit the Harvard Chan website for the latest newspress releases, and multimedia offerings.

For more information:

Karen Feldscher
kfeldsch@hsph.harvard.edu
617.432.8439

photo: CDC

###

Harvard T.H. Chan School of Public Health brings together dedicated experts from many disciplines to educate new generations of global health leaders and produce powerful ideas that improve the lives and health of people everywhere. As a community of leading scientists, educators, and students, we work together to take innovative ideas from the laboratory to people’s lives—not only making scientific breakthroughs, but also working to change individual behaviors, public policies, and health care practices. Each year, more than 400 faculty members at Harvard Chan School teach 1,000-plus full-time students from around the world and train thousands more through online and executive education courses. Founded in 1913 as the Harvard-MIT School of Health Officers, the School is recognized as America’s oldest professional training program in public health.

 

Medscape: Use of Broad Spectrum Antibiotics on the Rise

Use of Broad-Spectrum Antibiotics Rising

Nicola M. Parry, DVM

September 20, 2016

Overall rates of antibiotic use in US hospitals remained unchanged from 2006 to 2012, according to a new study. However, use of certain antibiotic classes, including some broad-spectrum antibiotics, has increased significantly.

James Baggs, PhD, from the Centers for Disease Control and Prevention, Atlanta, Georgia, and colleagues published the results of their study online September 19 in JAMA Internal Medicine.

"There were significant decreases in fluoroquinolones (20%) and first- and second-generation cephalosporins (7%) usage, but these decreases were offset by significant increases in vancomycin (32%) and agents with broad-spectrum activity against gram-negative bacteria, including carbapenem (37%), third- and fourth-generation cephalosporin (12%), and β-lactam/β-lactamase inhibitor combination antibiotics (26%)," the authors write. "Despite substantial reduction in fluoroquinolone use, this class remained the most commonly used antibiotic class in US hospitals in 2012."

Promotion of appropriate antibiotic use in the United States has become a national priority to address the public health implications associated with rising bacterial resistance to antibiotics. As a consequence, the National Strategy for Combating Antibiotic-Resistant Bacteria was released by the US government as an executive order that aims to control the problem of resistance.

Antibiotic use surveillance plays a key role in this strategy, as well as within hospital antibiotic stewardship programs identified by the Centers for Disease Control and Prevention.

"A better understanding of antibiotic use in US hospitals can inform stewardship efforts by identifying targets for reducing inappropriate or unnecessary prescribing," the authors note.

However, previous national surveys of antibiotic use in hospitals have been limited by diversity in patient populations and hospital facilities.

Therefore, in the current study, Dr Baggs and colleagues analyzed data from the Truven Health MarketScan Hospital Drug Database to estimate adult and pediatric inpatient use of antibiotics in the United States. Their analysis comprised data from approximately 300 hospitals and more than 34 million discharges, from January 1, 2006, to December 31, 2012.

Across all study years, the authors found that 55.1% of patients received at least one dose of antibiotics during a hospital stay, and the overall national days of therapy (DOT) was 755 per 1000 patient-days.

The analysis showed that overall antibiotic use did not change significantly over time (total DOT increase, 5.6; 95% confidence interval [CI], −18.9 to 30.1; P = .65).

Nevertheless, the authors identified important trends within individual antibiotic classes, including significant decreases in the use of fluoroquinolones, aminoglycosides, first- and second-generation cephalosporins, sulfa antibiotics, metronidazole (P < .001 for all), and penicillins (P = .01), with the greatest decrease seen among fluoroquinolones.

However, they also found significant increases in the use of third- and fourth-generation cephalosporins, 10.3 (95% CI, 3.1-17.5); macrolides, 4.8 (95% CI, 2.0-7.6); glycopeptides, 22.4 (95% CI, 17.5-27.3); β-lactam/β-lactamase inhibitor combinations, 18.0 (95% CI, 13.3-22.6); carbapenems, 7.4 (95% CI, 4.6-10.2); and tetracyclines, 3.3 (95% CI, 2.0-4.7).

"Our study is the first, to our knowledge, to provide national estimates of temporal trends in antibiotic use among US hospitals," the authors write, adding that this is the largest study of antibiotic use in US hospitals to date, including a wide variety of hospital types.

They also acknowledge the study's limitations, including its reliance on administrative data, which probably contained some misclassified pharmacy, clinical, and facility information.

Dr Baggs and colleagues emphasize concern about increasing use of some broad-spectrum antibiotics, and note that analyzing patterns of antibiotic use in US hospitals may have important implications for combating resistance to antibiotics.

"Our findings can help inform national efforts to improve antibiotic use by suggesting key targets for improvement interventions," the authors conclude.

Overuse Is a Psychological Problem

In an accompanying editorial, Ateev Mehrotra, MD, MPH, and Jeffrey A. Linder, MD, MPH, from Harvard Medical School, Boston, Massachusetts, stress that overuse of antibiotics is largely a psychological problem, not a knowledge problem or a diagnostic problem.

"We, as physicians, want to appear capable to our patients and not give the impression they have wasted either our time or their own," they say. "In addition, it feels easier for us as physicians to do something now rather than wait for a problem to arise."

To help reduce inappropriate antibiotic prescribing, Dr Mehrotra and Dr Linder therefore suggest three strategies. First, instead of describing antibiotic prescribing as a public health concern, they suggest presenting it as an individual patient concern: clinicians should inform patients that the harms of antibiotic use include rashes, diarrhea, Clostridium difficile infection, and harboring antibiotic-resistant bacteria for a time.

Second, they also recommend greater use of social psychology and behavioral science strategies to reduce antibiotic overprescribing. "Order entry systems that force physicians to provide a publically visible justification for prescription reduced inappropriate antibiotic prescribing from 23% down to 5%," the editorialists say. Similarly, peer comparison feedback, including informing clinicians when they are "not a top performer," makes them think about their professional reputation when they prescribe an antibiotic. In one study, "[s]uch feedback reduced inappropriate antibiotic prescribing from 20% to 4%," they add.

Third, they recommend preventing ambulatory visits whenever possible, describing office visits for colds, for example, as "wasteful, error-prone events." Instead, patients' use of self-triage Internet tools or smartphone apps could avoid many inappropriate antibiotic prescriptions.

Although clinician education and new diagnostics may help reduce the growing problem of antibiotic resistance, Dr Mehrotra and Dr Linder emphasize the need to recognize the emotional factors that drive clinicians to inappropriately prescribe antibiotics. "Future interventions need to counterbalance these factors using tools from behavioral science to reduce the use of inappropriate antibiotics," they conclude.

This study was funded by the Centers for Disease Control and Prevention. The authors and editorialists have disclosed no relevant financial relationships.

JAMA Intern Med. Published online September 19, 2016. Article full textEditoral extract

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Cite this article: Use of Broad-Spectrum Antibiotics Rising. Medscape. Sep 20, 2016.

Use of Broad-Spectrum Antibiotics Rising

A newly published Centers for Disease Control and Prevention study in JAMA Internal Medicine shows that while overall use of antibiotics is unchanged in U.S. hospitals, there has been a significant shift to increased use of broad-spectrum antibiotics.  Overuse of broad-spectrum antibiotics is believed to contribute to the crisis of antimicrobial resistance. The full article can be found here.

UN meeting tackles the 'fundamental threat' of antibiotic-resistant superbugs

The UN secretary general, Ban Ki-moon, said antimicrobial resistance is a “fundamental threat” to global health and safety at the first general assembly meeting on drug-resistant bacteria.

A microbiologist works with tubes of bacteria samples in a US antimicrobial resistance and characterization lab. Photograph: David Goldman/AP

A microbiologist works with tubes of bacteria samples in a US antimicrobial resistance and characterization lab. Photograph: David Goldman/AP

Amanda Holpuchin New York

The Guardian, US Edition

Wednesday 21 September 2016 00.01 EDTLast modified on Wednesday 21 September 2016 17.00 EDT

It is only the fourth time the general assembly has held a high-level meeting for a health issue.

“If we fail to address this problem quickly and comprehensively, antimicrobial resistance will make providing high-quality universal healthcare coverage more difficult if not impossible,” said Ban. “It will undermine sustainable food production. And it will put the sustainable development goals in jeopardy.”

Just before world leaders convened for the meeting, all 193 member states agreed in a declaration signed on Wednesday to combat the proliferation of antibiotic resistance.

The declaration routes the global response to superbugs along a similar path to the one used to combat climate change. In two years, groups including UN agencies will provide an update on the superbug fight to the UN secretary general.

It is estimated that more than 700,000 people die each year due to drug-resistant infections, though it could be much higher because there is no global system to monitor these deaths. And there has been trouble tracking those deaths in places where they are monitored, like in the US, where tens of thousands of deaths have not been attributed to superbugs, according to a Reuters investigation.

Resistance isn’t futile – how to tackle drug-resistant superbugs

Scientists have known for more than half a century that patients could develop resistance to the drugs used to treat them – one of the first people to sound the alarm was Alexander Fleming, who is credited with creating the first antibiotic, penicillin, in 1928. He cautioned of the impending crisis while accepting his Nobel prize in 1945: “There is the danger that the ignorant man may easily underdose himself and by exposing his microbes to non-lethal quantities of the drug make them resistant.”

But scientific innovation, and increased awareness, has shown the severity of the threat. The World Bank announced this week that without containment, the economic impact of the crisis makes it unlikely for the UN to reach its sustainable development goals for 2030.

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“The scale and nature of this economic threat could wipe out hard-fought development gains and take us away from our goals of ending extreme poverty,” said the World Bank president, Jim Yong Kim. “We must urgently change course to avert this potential crisis.”

There has also been considerable advocacy by health officials, like Sally Davies, chief medical officer of the UK.

“Drug-resistant infections are firmly on the global agenda but now the real work begins,” Davies said in a statement. “We need governments, the pharmaceutical industry, health professionals and the agricultural sector to follow through on their commitments to save modern medicine.”

The World Health Organization director general, Margaret Chan, said on Wednesday that it was imperative for consumers and medical providers to rely less on antibiotics for disease treatment.

“On current trends, a common disease like gonorrhea may become untreatable,” Chan said. “Doctors facing patients will have to say, ‘I’m sorry - there’s nothing I can do for you.’”

Margaret Chan, director general for the World Health Organization, speaking at another UN event on refugees and migrants. Photograph: Julie Jacobson/AP

Margaret Chan, director general for the World Health Organization, speaking at another UN event on refugees and migrants. Photograph: Julie Jacobson/AP

She also called for more innovation in antibiotic development, noting that only two new classes of antibiotics reached the market in the past half century. “The emergence of bacterial resistance is outpacing the world’s capacity for antibiotic discovery,” Chan said.

She warned specifically about gram-negative bacteria, which causes infections like pneumonia, wound or surgical site infections and meningitis in healthcare settings, and is proving increasingly resistant to antibiotics.

“With few replacement products in the pipeline, the world is heading to a post-antibiotic era in which common infections, especially those caused by gram-negative bacteria, will once again kill.”

Signatories to the UN declaration committed to encouraging innovation in antibiotic development, increasing public awareness of the threat and developing surveillance and regulatory systems on the use and sales of antimicrobial medicine for humans and animals.

Only three other health issues have been the subject of general assembly high-level meetings: HIV/Aids, non-communicable diseases and Ebola.

Mark Woolhouse, professor of infectious disease epidemiology at the University of Edinburgh, said he was encouraged that unlike with HIV/Aids and Ebola, the UN is addressing this health crisis before it has spun out of control. 

“It’s very serious indeed – it’s killing people around the world at the rate of hundreds of thousands of year and we all expect it to get worse if something isn’t done now,” Woolhouse said. “But the UN is coming in at just the right time, in a sense.”

New Mexico Startup Avisa Pharma Chosen by National Startup Association as a Top University Company

By STC

August 19, 2016

Albuquerque, NM, August 19, 2016—Avisa Pharma, a New Mexico startup commercializing diagnostic breath test technology developed at the University of New Mexico, has been selected as a “Best University Startups 2016” company by the National Council of Entrepreneurial Tech Transfer (NCET2), an association of university startup officers.

Out of the 800 startups created each year from universities around the country, 200 companies were submitted by their universities and screened by NCET2 to find the top university startups for 2016.  Avisa was among 18 university companies chosen in the first round of winners.  During the week of August 29, a second round of 17 winners will be announced from the finalists. The selected companies were scored by a selection committee of 25 Fortune 500 corporate representatives.

The 35 winning companies will present in front of an audience of Global 1000/Fortune 500 companies, VCs and angels looking for investment opportunities at NCET2’s inaugural University Startups Demo Day to be held at the National Press Club and Congress on September 20 in Washington, DC.

STC CEO Lisa Kuuttila was thrilled to hear the news.

“Avisa’s breath test technology is an innovation based on outstanding research and development focused on improving the diagnosis and treatment of bacterial lung diseases that affect the young, the elderly, and poor populations around the world.  Along with Avisa, four other STC companies are finalists for the Best University Startup 2016 award—more than any other university start-up program in the country.   This is recognition of the high quality of these young companies being formed from UNM technologies.”

Avisa CEO David Joseph, co-founder of Avisa with UNM faculty member Graham Timmins, added:

“This is great news and a recognition that we are on the forefront of dealing with severe lung infections and the overuse of broad spectrum antibiotics.  Our breath test technology is targeted at emergency rooms, hospital floor units and intensive care units where serious cases of pneumonia are seen and antibiotic resistant superbugs are more likely to be present. The test will aid clinical decision making on use and choice of antibiotics within 10 minutes.”

Dr. Timmins is a faculty member in the Department of Pharmaceutical Sciences at UNM’s College of Pharmacy and chief science advisor to Avisa Pharma Inc.  The breath test is quick and non-invasive.  It measures the presence of the urease enzyme found in certain bacteria that cause pulmonary infection using a proprietary, nebulized drug inhaled by the patient.

Tony Stanco, Executive Director of NCET2, added his perspective on the selection and event:

“These are some of the most exciting early-stage investment opportunities presented by the country’s great universities. Universities, with deep networks of students, alumni, researchers, faculty and staff, are uniquely positioned to create the world’s most important new companies. These companies create high-value jobs and solve real problems with great promise to have a major impact on the world. The University Startups Demo Day is the university community’s opportunity to show investors and Congress the jobs and companies they help create.”

For more information about the University Startups Demo Day, visit the NCET2 website at http://ncet2.org.

ABOUT AVISA PHARMA

Avisa is a clinical stage company that is developing an exciting, next-generation technology that enables the rapid detection of a variety of respiratory pathogens within minutes after the patient inhales its proprietary drug substrate, AV-U13. The AV-BreathTest™ is a rapid 10-minute test that screens and detects respiratory infections including pneumonia, tuberculosis, COPD and cystic fibrosis with the speed and sensitivity that can also facilitate the monitoring of antibiotic therapy. The AVISAR SPEC™ laser spectrometer, under development by Avisa, incorporates major design advancements that have resulted in a highly portable, laptop-size detection device that will have enormous utility in point-of-care settings—from rural health clinics in the developing world to modern medical clinics and hospitals.  For more information, contact Avisa at info@avisapharma.com or 505-820-1400.  Visit the website at http://avisapharma.com/.

ABOUT STC.UNM

As the technology-transfer and economic-development organization for the University of New Mexico (UNM), STC.UNM (STC) protects and commercializes technologies developed at UNM by filing patents and copyrights and transferring them to the marketplace.  We connect the business community (companies, entrepreneurs and investors) to these technologies for licensing opportunities and the creation of start-up companies. STC’s vision is to play a vital role in New Mexico’s economic development and to be a leader in technology commercialization.  Under the leadership of CEO Lisa Kuuttila, STC is substantially growing its program using the Rainforest model to develop an innovation economy in New Mexico.  For additional information, contact Cara Michaliszyn, STC University Ventures & Engagements Manager, at cmichaliszyn@stc.unm.edu or 505-750-7592.  Visit the website at http://www.stc.unm.edu.

Proof of Concept Study to Detect Urease Bacteria in Lungs Using Aerosolized 13C Urea1 Published in Pediatric Allergy, Immunology and Pulmonology Journal

The results of a proof of concept study to determine if aerosolized 13C urea could detect Pseudomonas aeruginosa, a urease producing bacteria, in the lungs of cystic fibrosis patients was recently published in the peer-reviewed journal, Pediatric Allergy, Immunology, and Pulmonology. The lead author of the article and principal investigator of the study was Hengameh H. Raissy, PharmD from the Department of Pediatrics at the University of New Mexico’s School of Medicine.

In this study 20 mg and 50 mg doses of 13C-urea were administered via a jet nebulizer to three subjects with cystic fibrosis and known to be colonized with P. aeruginosa and three healthy controls. Breath samples were collected in bags prior to nebulization and then at 5, 10 and 15 minutes post-nebulization. Both the 20 mg and 50 mg doses were well tolerated by all study subjects. Both the 20 mg and 50 mg doses showed distinct separation in the 13CO2/12CO2 delta over baseline (DOB) between the CF subjects and the controls with the 5 and 10 minute post-nebulization breath samples. The 50 mg dose had better separation than the 20 mg dose and the largest separation was seen at 5 minutes post-nebulization with CF subjects having an average DOB of 9.5‰ vs 2.1‰ for the healthy controls.

1Raissy Hengameh H., Timmins Graham, Davies Lea, Heynekamp Theresa, Harkins Michelle, Sharp Zachary D., and Kelly H. William. Pediatric Allergy, Immunology, and Pulmonology. June 2016, 29(2): 68-73.

ATS and IDSA Release New Guidelines for Management of Adults with Hospital-acquired and Ventilator-associated Pneumonia

The American Thoracic Society (ATS) and the Infectious Disease Society of America (IDSA) have released new guidelines for the management of adults with hospital-acquired and ventilator-associated pneumonia. Major updates include a recommendation to shorten antibiotic therapy to 7 days (from 8 to 15) and consider discontinuation of antibiotic therapy based on procalcitonin levels and clinical criteria. In diagnosed cases of HAP and VAP, Avisa believes that once approved, its 13C-Urea BreathTest will aid antibiotic choice and similar to procalcitonin, will provide quantitative measures of antibiotic efficacy to aid decisions on antibiotic de-escalation. The 2016 guidelines replace the last update done in 2005.

New CDC Antibiotic Stewardship Program Will Affect Most US Prescribers

The crisis of antibiotic resistance has spurred the White House, Centers for Disease Control and Prevention (CDC), and the World Health Organization to promote the implementation of antibiotic stewardship programs in healthcare facilities. The CDC has put together a comprehensive antibiotic stewardship program that US healthcare facilities must implement if they wish to receive funding from the Centers for Medicare and Medicaid Services (CMS). Avisa believes that once approved, its 13C-Urea BreathTest will facilitate antibiotic stewardship efforts by providing rapid identification of urease pathogens at the point of care in patients diagnosed with pneumonia and aiding clinical decision making regarding antibiotic use and choice of antibiotics.

Matt Culler joins the Avisa team as VP of Finance

Matt Culler has joined the Avisa team as Vice President of Finance. Matt will work closely with CEO David Joseph to secure Avisa’s Series B financing for commercial development, pivotal clinical trials and FDA regulatory submission of the Avisa BreathTestTM as aid to antibiotic usage and selection for patients diagnosed with pneumonia in the emergency department. Prior to joining Avisa, Mr. Culler was Vice President, Finance & Operations at xF Technologies, a venture-backed renewable chemistry start-up. Before his work at xF Technologies, Mr. Culler was a Principal at Sun Mountain Capital, one of the largest venture capital firms headquartered in the Southwest. Prior to Sun Mountain Capital, Mr. Culler participated in financings totaling over $2 billion as a Senior Analyst in the Private Equity Placements Group of Bank of America’s investment banking business in New York City. Matt has a BBA in Finance with honors from the University of Texas at Austin.

New Antibiotic Stewardship Guidelines Issued by IDSA and SHEA

In response to the antibiotic resistance crisis, the Infectious Disease Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA) have released new national guidelines regarding antibiotic stewardship for inpatient populations including long term care. These guidelines replace those issued in 2007. In cases of diagnosed pneumonia, Avisa believes that once approved, its 13C-Urea BreathTest will facilitate guideline recommendations to increase use of oral antibiotics and reduce antibiotic therapy to the shortest effective duration for inpatient populations.

Avisa’s Biomarker Breath Test Detects Tuberculosis in South Africa Pilot Study

A ten minute breath test for rapid screening and detection of active tuberculosis

Santa Fe, NM, December 18, 2015: Avisa Pharma Inc. announced today that it successfully detected active TB in a pilot study in Durban, South Africa. This study included both suspected TB subjects and HIV- AIDS subjects that are often co-infected with TB, and controls. The AV-BreathTest™ detected TB in both cohorts confirmed by GeneXpert and standard TB culture. The AV-BreathTest™ measures the whole lung, in-vivo, does not require sputum, is point-of-care, shows results in less than 10 minutes and can monitor therapy. There are 9.5 million active TB cases worldwide, with at least 1 million infected children who have difficulty producing sputum.
According to David S. Joseph, Avisa’s President and CEO, “This pilot study allows us to plan our pivotal clinical trials in 2017 on multiple continents for regulatory approvals. Early screening triage and detection by our breath test biomarker can substantially reduce the spread of this terrible disease, reduce the need for time consuming, low-sensitivity smear microscopy and identify active TB in those patients with symptoms that have difficulty in producing sputum for culture. Moreover, since the test is less than 10 minutes, monitoring antibiotic therapy is another potential benefit of our technology given the major concern of multi-drug resistance.”

ABOUT AVISA
Avisa is a clinical stage company that is developing an exciting, next-generation platform technology that enables the rapid detection of a variety of respiratory pathogens within minutes after the patient inhales its proprietary drug substrate, the AV-U13 biomarker. Avisa licensed its core breath test technology with the University of New Mexico’s Science Technology Center (UNM-STC). The AV-BreathTest™ is a rapid 10-minute test that screens and detects respiratory infections with the speed and sensitivity that can also facilitate the monitoring of antibiotic therapy using a simple breath test. The AVISAR SPEC™ laser spectrometer, under development by Avisa, incorporates major design advancements – a point of care, battery powered device that can fit into a backpack for rural health clinics in high burden countries to medical offices and clinics, hospitals, emergency departments, urgent care centers, retail clinics and long term care facilities.

Wall Street Journal: New Diagnostic Tools Emerge in War Against Superbugs Aim of rapid-diagnosis technologies is to reduce unnecessary prescription of antibiotics

Belgium-based Biocartis Group is among the companies racing to develop diagnostic technologies to pinpoint causes of common infections.  PHOTO: FRANCOIS LENOIR/REUTERS

Belgium-based Biocartis Group is among the companies racing to develop diagnostic technologies to pinpoint causes of common infections.  PHOTO: FRANCOIS LENOIR/REUTERS

Aim of rapid-diagnosis technologies is to reduce unnecessary prescription of antibiotics

By DENISE ROLAND

Nov. 16, 2015 2:52 p.m. ET

A new front is emerging in the fight against antibiotic-resistant superbugs—one that doesn’t involve the development of new drugs.

Companies are racing to develop diagnostic technologies that can be used by hospitals and clinics to pinpoint the cause of common infections quickly. That should cut down on the unnecessary prescription of antibiotics, a major driver of drug-resistance in bacteria.

Traditional diagnostic testing via specialist laboratories can take several days to deliver results, so doctors who want to prescribe an immediate remedy often use a patient’s symptoms to guess what is causing an illness. More than a quarter of the time, this leads to antibiotics being prescribed unnecessarily, according to a 2013 study in the U.S. published in the Journal of Antimicrobial Chemotherapy. In respiratory infections, two thirds of antibiotic prescriptions are unnecessary, according to the same study.

Now, a new market is opening up for diagnostics that can be used outside of specialist labs, and it is growing at a steady clip. The U.S. market for so-called point-of-care diagnostics for infectious disease stands at $533 million and is growing 7% a year, according to Divyaa Ravishankar, an analyst at consultancy Frost & Sullivan.

 

 

There is pent-up demand for tests that can return results quickly, said Nicholas Jansen, an analyst at Raymond James. “There’s always been a desire by hospitals and government agencies to minimize the use of antibiotics,” he said. “But the problem was that there wasn’t a technology available…that would make it cost-effective.”

Carl Heneghan, professor of evidence-based medicine at the University of Oxford, said the tool that doctors want most is one that can test for several potential culprits simultaneously.

BioFire Diagnostics Inc., a Salt Lake City-based division of France’s bioMérieux SA, makes one such device. Its test looks for several pathogens at once, depending on the type of infection, and produces results in about an hour. Sales of these devices, which cost $35,000 apiece, more than doubled in the past year, according to company filings.

 

Belgium-based Biocartis Group NV is taking a similar approach. It is working on a test that can tell within 50 minutes which of 20 potential viruses and bacteria is causing a respiratory infection.

 

Still, there are stringent barriers to getting diagnostics into the hands of doctors in the U.S., where companies must satisfy regulators that their technology is simple enough for those without laboratory training. BioMérieux’s test currently is limited to specialist laboratories in the U.S., though it is already used by doctors in small clinics elsewhere, according to Mark Miller, chief medical officer at bioMérieux.

Other companies, such as Los Gatos, Calif.-based GeneWeave Biosciences Inc., have focused purely on identifying antibiotic resistance. Its “Smarticles” technology interacts with living bacteria to produce light. If the bacteria in question are drug-resistant, they will continue to shine in the presence of an antibiotic, signaling that the doctor should try a different drug. The test takes less than four hours and has already caught the eye of Roche Holding AG’s diagnostics arm, which in August agreed to acquire GeneWeave for up to $425 million.

Sunnyvale, Calif.-based Cepheid was one of the first companies to develop a hospital diagnostic for infections when, in 2007, it launched a one-hour test for methicillin-resistant Staphylococcus aureus, or MRSA. Its test, at around $40, is much more expensive than the slower lab test, which costs about a dollar. But Cepheid “was able to convince hospitals they’d save money in overall costs of care by stratifying patients” based on whether they had the resistant strain, according to Dan Leonard, analyst at Leerink Partners.

Still, innovative diagnostic technologies can struggle to gain momentum, according to Prof. Heneghan. The companies that make them normally don’t have the funds to run large-scale clinical trials to convince governments and other payers of their cost-effectiveness. According to analysis by health consultancy Diaceutics, it costs about $50 million to market and sell a novel diagnostic, almost as much as the $55 million needed to develop it in the first place.

A case in point is a rapid diagnostic test from Waltham, Mass.-based Alere Inc., that helps doctors figure out whether a chest infection is serious enough to warrant the use of antibiotics. Ten years after it was launched, it is used in fewer than half of European countries, even though studies have shown antibiotic prescribing is around 20% lower in regions where it is used.

And despite the recent flurry of advances, Dr. Anthony Fauci,director of the U.S. National Institute of Allergy and Infectious Diseases, said the field isn’t moving fast enough. “We do not have an entire array of readily available, reasonably inexpensive” and accurate diagnostics that doctors can use, he said.

To spur more innovation in this area, groups in the U.K. and U.S. have launched publicly funded prizes and grants worth a combined $36 million for developing rapid diagnostics with the aim of curbing antimicrobial resistance. And the role of diagnostics is receiving more recognition as the threat of drug-resistant superbugs climbs the political agenda.

“Most casual, and some very informed, observers automatically think the main part of the problem is getting new drugs,” said economist Jim O’Neill, who is running a review on antimicrobial resistance for the U.K. government. “At least as big, if not bigger, is reducing the demand side, of which state-of-the-art diagnostics is front and center.”

Write to Denise Roland at Denise.Roland@wsj.com

 

TB Now Ranks With AIDS as a Leading Cause of Death Worldwide

Medscape Medical News

Troy Brown, RN

October 29, 2015

The tuberculosis (TB) rate has fallen by nearly half (47%) since 1990, according to the World Health Organization (WHO). Still, 1.5 million people succumbed to the disease in 2014, and it ranks alongside HIV/AIDS as the leading cause of infectious disease deaths worldwide.

The WHO released its Global Tuberculosis Report 2015 yesterday.

"The report shows that TB control has had a tremendous impact in terms of lives saved and patients cured," WHO Director-General Margaret Chan, MD, said in a WHO news release. "These advances are heartening, but if the world is to end this epidemic, it needs to scale up services and, critically, invest in research."

Much of the improvement has occurred since 2000, when the Millennium Development Goals were established. Since then, effective diagnosis and treatment have prevented 43 million deaths, and global TB incidence has dropped by 18%, with a 1.5% reduction each year.

The world has largely met the Millennium Development Goal that called for stopping and reversing TB incidence by 2015; the goal has been met globally and in 16 of the 22 high-burden countries that together account for 80% of cases.

"Far From Sufficient"

"Despite the gains, the progress made against TB is far from sufficient," Mario Raviglione, MD, director of WHO's Global TB Programme, said in the news release. "We are still facing a burden of 4,400 people dying every day, which is unacceptable in an era when you can diagnose and cure nearly every person with TB."

In 2014, 890,000 men, 480,000 women, and 140,000 children died from TB, for a total of 1,510,000 deaths. Of those, 400,000 deaths were in individuals coinfected with HIV. The total number of deaths from HIV that year was approximately 1.2 million, including the 400,000 patients with TB.

Global totals for new TB cases (9.6 million) were higher in this year's report, but this is probably the result of "increased and improved national data and in-depth studies," as opposed to any rise in the spread of TB, according to the WHO news release.

Some 54% of new cases were in China, India, Indonesia, Nigeria, and Pakistan. An estimated 3.3% of those individuals are infected with multidrug-resistant TB (MDR-TB), and this level has remained steady in recent years.

Detection, Treatment Gaps Significant

More than one third (37.5%) of the 9.6 million cases of TB that occurred in 2014 were undiagnosed or not reported to national authorities.  These gaps are particularly serious for those with MDR-TB, which is a public health crisis. Only one quarter (123,000) of the 480,000 cases were found and reported to national authorities. The largest numbers of these cases were in China, India, and the Russian Federation.

Treatment initiation for individuals diagnosed with MDR-TB rose substantially, and most individuals diagnosed with MDR-TB in 2014 began treatment. Cure rates for patients with MDR-TB were more than 75% in 43 countries. Worldwide, the average cure rate for patients who were treated for MDR-TB is only 50%.

Progress is occurring: 77% of patients identified with both HIV and TB received antiviral medications in 2014. In addition, almost 1 million patients with HIV received TB preventive therapy in 2014, an increase of approximately 60% from 2013. More than half (59%) of these patients live in South Africa.

Financing Shortfalls Impede Progress

The report identifies significant gaps in funding for the implementation of interventions ($1.4 billion gap) and research and development of new diagnostic tests, drugs, and vaccines ($1.3 billion).

"The [American Thoracic Society (ATS)] reiterates its call to the international community to fully fund TB control and research and development programs," Dean Schraufnagel, MD, from the University of Illinois Hospital and Health Sciences System in Chicago, said in an ATS news release.

"In its report, the WHO describes insufficient funding as the key obstacle to battling TB. This includes the urgent need to develop new diagnostic, treatment and prevention tools. President Obama will shortly be releasing an ambitious National Action Plan to Combat Multi-Drug Resistant Tuberculosis globally and in the US," he said.

"We urge the Administration and Congress to fully implement and fund this important global health initiative through the [Centers for Disease Control and Prevention], [US Agency for International Development], and TB research through the National Institutes of Health. We simply must step up our efforts to combat TB, now the leading global infectious disease killer alongside HIV/AIDS, and this new plan will provide the guidance for doing so," Dr Schraufnagel, past president of the ATS, said.

Starting in 2016, the global focus will be more on ending the global TB epidemic as opposed to simply controlling TB. The End TB Strategy, adopted by all WHO member states, will aim to decrease TB incidence by 80%, reduce TB deaths by 90%, and "eliminate catastrophic costs for TB-affected households by 2030," according to the WHO news release.

"Ending the TB epidemic is now part of the Sustainable Development Goal agenda," Eric Goosby, MD, UN Special Envoy on Tuberculosis, said in the WHO news release. "If we want to achieve it, we'll need far more investment — at a level befitting such a global threat. We'll also need progress on universal health coverage and poverty alleviation. We want the most vulnerable communities worldwide to gain first, not last, in our efforts."

"The ATS, originally founded as the American Sanitorium Association in 1905, and its more than 15,000 worldwide members pledge to continue our work to eliminate TB. In collaboration with the WHO and other partners, we have produced international standards of care and are providing technical assistance in implementing those standards and other TB control, treatment and prevention strategies in over 23 countries," Dr Schraufnagel said in the ATS news release.

"Global Tuberculosis Report 2015." WHO. Published online October 28, 2015.  View report