Verax Gains FDA Clearance for the Rapid Detection of Bacterial Contaminants in Platelets Intended for Transfusion

Verax Biomedical today announced that the company has gained FDA clearance to expand the use of its Verax Platelet PGD® test—a rapid test for the detection of bacterial contamination in platelets intended for transfusion. The new FDA clearance makes the Verax Platelet PGD test the only rapid test on the market cleared by the FDA to check every commonly distributed platelet type in the United States.

"Bacterial contamination of platelets is the number one infectious risk to transfusion recipients, and this FDA clearance makes the Verax Platelet PGD test the industry standard when it comes to the detection of bacteria in platelets," said Verax Biomedical CEO Jim Lousararian. "We applaud FDA for taking this critical step to help ensure patient safety and we look forward to continuing to work with the Agency, the transfusion community and other health care stakeholders to combat the severe risk of bacterial contamination in the U.S. blood supply."

Annually, more than 6 million platelet doses are transfused worldwide, and approximately 1 in 2,000 doses are contaminated by bacteria. The Verax Platelet PGD test is an immunoassay used on the day of transfusion at the point of care—a hospital or transfusion service—to quickly detect bacterial contamination in platelets and protect patients from receiving contaminated transfusions. The presence of bacteria in platelets can pose serious risks for patients, including sepsis—a life-threatening infection in the blood stream. The test is a more cost effective and less invasive approach to platelet bacterial safety than pathogen inactivation technologies.

The Verax Platelet PGD test is already used by many major U.S. cancer centers and children's hospitals to check two types of platelets: apheresis platelets in plasma (also known as single donor platelets, or SDPs) and whole blood derived platelets (WBDs). With this new FDA clearance, the Platelet PGD test can now be used as a Safety Measure to check two additional platelet types: pre-storage pool platelets (e,g, Acrodose™ platelets) and apheresis platelets in PAS-C additive solution and plasma.

Most health care facilities currently use single donor platelets (SDPs) or whole blood derived platelets (WBDs). As health care facilities expand their use of other platelet types, such as pre-storage pool platelets and apheresis platelets in PAS-C additive solution and plasma, today's FDA clearance means facilities will be able expand their use of the Verax Platelet PGD test to help reduce infectious risk to their patients.

The Verax Platelet PGD test was first cleared by the FDA in 2007 for detecting bacterial contamination in leukoreduced apheresis platelets and in 2009 for use with whole-blood derived platelets.

Verax's patented Pan Genera Detection (PGD) technology is based on the insight that recent advances in the field of immunotherapeutic agents can be used to develop tests to detect the broad array of bacteria in blood components. This broad detection is based on the existence of shared, or conserved, antigens that are common to the cell walls of the two broad classes of bacteria - Lipoteichoic Acids on Gram-positive bacteria and Lipopolysaccharides on Gram-negative bacteria. Verax targets these conserved Gram-positive and Gram-negative antigens to test biological samples for a broad range of bacterial contaminants by using pan genera binding agents to directly bind to these targets. This detection approach does not depend upon surrogate measures for bacterial presence or the measurement of byproducts of bacterial growth.

One major advantage of this approach is the large number of conserved antigens found on the cell surface of Gram-positive and Gram-negative bacteria. This provides a large number of detection events for a relatively small number of contaminating bacteria, which translates into the potential for a highly sensitive test system which is both simple and rapid to perform.

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US FDA Grants CLIA waiver for Roche's cobas Liat PCR System and Strep A Assay

In the wake of receiving a CLIA waiver for its rapid, point-of-care PCR testing device, Roche executives this week provided an update on the platform's infectious disease test menu pipeline.

The platform, called the Roche cobas Liat, received CLIA waiver yesterday along with a 15-minute molecular assay for group A Streptococcus.

The strep test is the first on (Lab-In-A-Tube) Liat to be CLIA waived for low-complexity healthcare settings, such as physician's offices and pharmacy clinics. The firm also has an influenza A/B assay that is FDA cleared and awaiting CLIA decision, and that assay has been the subject of recent scientific evaluations.

Roche acquired the Liat technology a year ago when it bought diagnostics developer Iquum. The acquisition included the FDA-cleared flu test, and Roche has since stated its intention to populate the system with other tests, officially launching Liat late last year.

This week, Todd Keirns, group marketing manager for microbiology at Roche Diagnostics, told GenomeWeb that Roche is currently working on a combination flu A/B plus respiratory syncytial virus test, an assay targeting both Staphylococcus aureus and methicillin-resistant Staphylococcus aureus (MRSA), and a Clostridium difficile test.

"The MRSA/staph and C. diff tests do not have an actual timeline yet, but the flu A/B plus RSV we should be submitting this year for 510(k) approval," he said.

Liat is a relatively tiny platform, about the size of a single-serve coffee maker. The sample-in, answer-out technology also has design features that enable standard PCR thermal cycling in about 20 minutes.

Specifically, reagents for each step of PCR are crimped into bubbles of packaging partitioned from one longer string. The platform then massages the sample through each isolated segment, some of which contain magnetic beads for target capture.

CLIA waiver for low-complexity settings requires very simple handling steps, and the Liat delivers on this. "You unscrew the top [of the reagent-containing assay tube], you use the pipette that comes with [the test] to take 200 microliters of your sample, put it in, screw the top on, and then the top of the Liat opens and you put the reagents in and close it," explained John Ogden, senior scientific affairs manager at Roche Diagnostics.

Ogden said the PCR's speediness is due to the use of spatial thermal cycling. Instead of sample being heated on a block that ramps between temperatures, the assay tube is made to oscillate between two blocks, each at a constant temperature.

The 20-minute run time also includes nucleic acid isolation, Ogden pointed out, so the PCR thermal cycling is quite fast relative to other standard platforms and it does not use special polymerases to Ogden's knowledge.

"It follows traditional PCR assay design — the attempt is to make it so the performance you get out of this will be exactly the same as you get at any level of Roche product," he said.

The device is also barcode driven, with less than five minutes of hands-on time. "You just hit go, and it does the PCR cycling, and in the end it provides a readout on a screen and it can be interfaced to have a readout of electronic results into your system," Ogden said.

Six-channel multiplexing capabilities were also part of the technology while it was being developed by Iquum, as previously reported.

Scientific studies of Liat

The cobas Liat influenza A/B assay was the subject of a study published online last week in the Journal of Clinical Microbiology.

The investigator-initiated research was done at the Mayo Clinic, comparing the Liat assay with the Simplexa Flu A/B & RSV Direct assay from Focus Diagnostics.

Roche provided the researchers a cobas Liat instrument and enough reagents to do the comparison, Ogden said.

"Because it is an investigator-initiated study [the researcher] has complete control over the design of the study, the protocol, and the data," Ogden noted. "We have no input on whether or not he publishes, or what he says, [and] we rely on the third-party peer review process to determine whether or not something has scientific value."

The JCM study reported overall agreement in 196 out of 197 patient samples and a specificity of 100 percent. The sensitivity relative to Simplexa was 99.2 percent and 100 percent respectively for influenza A and B. The tests ran in less than 20 minutes, compared to about 60 minutes for the Focus test, and required less than five minutes of hands-on time

Related work assessing the test's impact on patient management was also presented in abstract form at the Clinical Virology Symposium last month.

Laboratorians at the Hennepin County Medical Center in Minneapolis, Minnesota compared the Liat flu A/B test to the GenMark respiratory viral panel.

According to the abstract, about 15 percent of a small sample of patients in the emergency department tested positive for flu by the Liat test and there was 100 percent correlation with the GenMark panel. All had influenza B.

Pre- and post-test surveys revealed rapid testing led to changes in patient management, such as initiation or discontinuation of antivirals and antibiotics.

And 20 percent of patients for whom an admission order had been initiated were subsequently discharged upon negative Liat flu testing. The study also surveyed the patients themselves, revealing 90 percent of them felt rapid testing improved their hospital visit.

Notably, two other preliminary studies presented at CVS reported on performance characteristics of the flu A/B test.

One found high sensitivity and specificity in detecting the H3N2 flu strain that was circulating this past season, compared to a Prodesse assay from Hologic and the BioFire FilmArray respiratory panel.

However, the other evaluation compared the Liat test to a lab-developed qPCR assay and found the performance of the Liat "suffers" with viral loads near the lower limit of detection, although that study also emphasized the Liat's rapid turnaround time compared to the lab test's 3.5 hours from sample to result.

There are currently only two other studies of the Liat system in the scientific literature, both describing a quantitative viral load assay for HIV-1.

These were initiated prior to Roche's acquisition of the technology and spokespersons at the firm could not confirm whether the HIV-1 work is continuing.

The first, a proof-of-principle study of the assay, was published in the Journal of Infectious Disease in 2010 and also provided background on the Liat platform in general.

The second study, by a group in Johannesburg, was published online in March in the Journal of Clinical Microbiology. It reported 30 to 35 minutes of total test time after pipetting less than 200 microliters of patient sample into the assay.

It also compared two tests, referred to as Liat HIV Quant plasma and Liat HIV Quant whole-blood, to the Roche Cap CTMv2.0 and Abbott RealTime HIV-1 PCR assays. That study concluded the Liat technology is "user-friendly and robust" and suggested it could be interchanged with existing viral load technologies in South Africa.

Whether Roche will further develop this HIV test is unknown. "Iquum may have been looking into that, but I can't confirm that the projects that Iquum had are being continued by Roche," Ogden said.

Potential competition

The Liat Strep A test is the second molecular point-of-care test ever to receive CLIA waiver for low complexity settings.

Alere's influenza assay was the first, and representatives told GenomeWeb of that firm's intent to market to physician's offices and pharmacy clinics. Alere is also populating its Alere i platform with a strep A test that has been FDA cleared and is now in the CLIA review process.

Further, that firm has a second rapid molecular platform, the Alere q, which has received CE marking for an HIV detection assay that will soon be commercialized in non-US markets, and for which Alere is developing a quantitative HIV assay. Additional menu items for the Alere i include RSV, C. difficile, and gonorrhea/chlamydia. Alere q assays in development include Ebola, tuberculosis diagnosis, TB drug resistance testing, and hepatitis C testing.

Whether and how these two platforms will now compete remains to be seen. They have different core technologies, but both enable molecular testing in the timeframe of a patient visit and report similar test menu development. Roche may have a more recognizable brand, but Alere may have inroads into in the clinical and hospital market resulting from its immunoassay business.

Roche's Ogden pointed out that the Liat platform also has advantages for "stat tests in a laboratory environment," a space in which Roche may have a natural dominance. In this respect, it may actually compete more with the Cepheid GeneXpert platform.

"There will be certain diseases where it is very important that you know immediately when someone comes into an emergency department what it is, and there are others where they don't necessarily have to be done that fast, but once they're delivered to the laboratory you would like to turn them around quickly," Ogden said, adding that the menu pipeline will "address both of those areas."

Keirns agreed. "We're not looking at it as purely a point-of-care device; this is a molecular technology that can be deployed in many different spaces in the healthcare setting," he said.

In terms of competitive advantage, Keirns also pointed out that head-to-head trials will be important in the future. He declined to say whether Roche is planning to contract with pharmacy clinics, or how it will deploy its marketing resources.

The cost of the Liat is "very competitive in the market and is based on the utilization by the customers," Keirns said, adding that this "will vary by customer based on their volume and what their needs are." The Alere i platform, by comparison, was previously reported to cost $8,500 and about $70 per assay for the influenza test, with lower prices often negotiated with users.

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Perfect Score for MIT 1000 Optical Rapid Method on Staphylococcus Single Blind Identification Study

Micro Imaging Technology, Inc. (MIT) announced the result of a blind study conducted with its MIT 1000 System as part of a collaboration with Northern Michigan University (NMU) to identify and differentiate Staphylococcus aureus (S. aureus). The study was conducted by the NMU lab of Josh Sharp, Ph.D., Assistant Professor of Biology, in cooperation with the Microbiology lab at UP Health Systems in Marquette, Michigan to investigate whether the MIT 1000 System was able to detect S. aureus strains isolated from humans. In the single blind study, UP Health Systems provided 90 different previously tested, but unidentified cultures of bacteria to the Sharp lab to determine whether clinical isolates of S. aureus could be identified with the MIT 1000. Clinical isolates might have more variability in characteristics such as size, shape and pigment production compared to laboratory strains and, therefore, more challenging to identify. Out of those 90 samples, the MIT 1000 identified 30 as Staphylococcus species -- a 100% match to the hospital's independent test findings. Not only did the MIT 1000 accurately identify the 30 cultures of various Staphylococcus species, but the remaining 60 non-Staphylococcus cultures tested in the study were correctly ruled out as Staph species (no false positives).

As the Company previously announced, the goal of the collaboration with NMU is to rapidly and cost-effectively identify Staphylococcus aureus (S. aureus) and Methicillin Resistant Staphylococcus aureus (MRSA) using the MIT 1000 System, a bacterial cell based identification system that can identify pathogenic bacteria in three minutes (average) at significant cost savings per test. "The data from the single blind study with UP Health Systems is encouraging and supports the concept that the MIT 1000 Staphylococcus species Identifier can differentiate Staphylococcus species based on light scattering patterns," noted Dr. Sharp. "Additionally, the bacteria strains in this study were human isolates, which may have varying characteristics, yet the MIT Identifier was robust enough to correctly recognize them as Staphylococcus."

Dr. David Haavig, MIT Chief Scientist, said, "We are extremely pleased with the results of this study and thank Dr. Sharp and his laboratory staff for their time and efforts in developing and conducting the study. We are also grateful to UP Health Systems for their valuable cooperation in providing the test cultures."

MIT has developed and patented the MIT 1000, a stand-alone, rapid, optically-based, software driven system that can identify pathogenic bacteria and complete an identification test, after culturing, in three (3) minutes (average) at the lowest cost per test when compared to any other conventional method. It does not rely on chemical or biological agents, conventional processing, fluorescent tags, gas chromatography or DNA analysis. The process requires only clean filtered water and a sample of the unknown bacteria.

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Meridian Bioscience Europe Launches New Molecular Tests for the Detection of Herpes Simplex Virus Type 1 and Type 2

Meridian Bioscience, Inc. announced that it has received the CE Mark for new molecular assays for the detection of Herpes Simplex Virus Type 1 (HSV-1) and Type 2 (HSV-2), to be run on its molecular platform, illumigene®. The HSV 1&2 assays are additions to the portfolio of molecular tests available for use on the illumigene platform; including C. difficile, Chlamydia, Group A Streptococcus, Group B Streptococcus, Gonorrhea, Mycoplasma and Pertussis. All illumigene® products are distributed in the EMEA regions by Meridian Bioscience Europe and in additional international markets by the Company’s global distribution network.

Mike Shaughnessy, Executive Vice President and President of Meridian Global Diagnostics stated, “With the launch of our HSV 1&2 tests, our illumigene platform now supports nine molecular assays. Coupled with our Chlamydia and Gonorrhea assays launched earlier this year, Meridian is now able to offer a compelling STD and Women's Health portfolio that will empower laboratories to test in-house while using best in practice diagnostic methods for both infections.” (1,2)

illumigene HSV 1&2 assays utilize cutaneous and mucocutaneous specimens from symptomatic patients for the qualitative detection and differentiation of HSV-1 and HSV-2. The test procedure is the same for both HSV-1 and HSV-2, and both test results are available within one hour in order to guide patient counseling and management. Unlike other molecular systems, the illumigene platform does not require expensive capital equipment or costly annual service contracts. The performance and simplicity of this technology, along with its cost efficiency and small footprint, make these new assays ideal for enabling a more rapid diagnosis in a moderately complex laboratory setting.

HSV is a major health concern because both HSV-1 and HSV-2 can be transmitted perinatally from mother to child, and in some cases, cause fatal infection in infants. Other serious complications from HSV 1&2 include blindness, encephalitis, aseptic meningitis and an increased risk of acquiring and transmitting HIV infection. Testing with illumigene HSV 1&2 facilitates same day reporting, treating and counseling for optimal patient management.

(1) Department of Health and Human Services, Centers for Disease Control and Prevention, Sexually Transmitted Diseases Treatment Guidelines, Recommendations and Reports, 2010. MMWR 2010:59

(2) Patel R, Alderson S, Geretti A, et al. 2010 European guideline for the management of genital herpes. http://www.iusti.org/regions/Europe/pdf/2010/Euro_Guideline_2010_herpes.pdf

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POCARED Announces Real Time Identification of Bacterial Species and Antibiotic Resistance Markers Via Intrinsic Fluorescence

POCARED Diagnostics, a leading in-vitro diagnostic and pre-analytical technologies manufacturer announces a breakthrough in real time identification of bacterial species and antibiotic resistance markers utilizing its proprietary technology in the P 1000. POCARED's P 1000™ is a rapid automated platform that employs intrinsic fluorescence; optical data analysis and artificial intelligence to analyze multi-dimensional optical characteristics of microorganisms.

POCARED's P-1000 has successfully identified 5 antimicrobial resistance markers: KPC, NDM, vanB, mecA and OXA.

Performance data will be presented at the  ASM 2015  General Meeting, May 30 to June 2 in New Orleans, LA.

"Rapidly identifying bacterial species and their antimicrobial resistance markers provides the laboratory, clinicians and epidemiologists significant advances that assist in the care and management of the ill patient. POCARED is pleased to lead in the antibiotic stewardship efforts in the Healthcare setting," says Jonathan Gurfinkel, President and CEO of the company.

Increasing antimicrobial resistance is a global problem with surveillance of resistance a priority. The global market for antimicrobial resistance testing is greater than $500 million and is growing 5 to 7% annually. POCARED continues to develop solutions for today's Healthcare issues. The P 1000 is revolutionizing the detection, identification and enumeration of bacteria and yeast together with their antimicrobial resistance markers in a few minutes directly from culture.  It is a fully automated, reagent-free, real-time and easy to operate platform.

POCARED's P-1000™ is an automated rapid system that employs intrinsic fluorescence, optical data analysis and artificial intelligence methods to analyze multi-dimensional optical characteristics of microorganisms. It captures the emitted light from the interaction between photons and molecules to detect the pathogens' unique optical properties and subsequently an algorithm determines results.

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Genetic Signature of Sepsis Deciphered - Rapid Diagnostic Test Hopeful

Researchers have discovered a pattern in 11 genes that could make it quick and easy to diagnose sepsis, a serious life-threatening condition.

Sepsis is an extreme inflammatory reaction affecting the entire body and which causes around 37,000 deaths each year in the UK - a rapid diagnostic test could save many of those lives. 'It's critical for clinicians to diagnose sepsis accurately and quickly, because the risk of death from this condition increases with every passing hour it goes untreated,' explained Dr Purvesh Khatri, assistant professor of biomedical informatics research at Stanford University, USA and senior author of the study, which was published in Science Translational Medicine.

Most cases of sepsis are caused by bacterial infection, and if it is caught early it can be treated effectively with antibiotics. But sepsis can be very difficult to recognise, and existing diagnostic tests can be slow or inaccurate. 'Sepsis doesn't lend itself to easy recognition,' said Professor Greg Martin of Emory University, who was not involved in the study. 'Early in its course it is easy to treat but difficult to recognise, and once it has become more recognisable it is incredibly difficult to treat.'

Sepsis is difficult to distinguish from another similar condition - sterile inflammation - which is not caused by an infection. This condition isn't helped by antibiotics, which can actually make it worse.

The Stanford researchers set out to find whether the activity of certain genes was increased in response to sepsis alone. This was a challenging task since around 20,000 genes are known to increase in activity during inflammation. Using information collected from previous studies, they analysed around 2,900 blood samples from almost 1,600 patients, taking into account how soon the blood test was done after the initial injury that caused the sepsis.

'We were able to identify a slight bump in activity of these 11 genes in patients, two to five days prior to their clinical diagnosis,' said Dr Khatri. 'We think we've got the makings of a diagnostic blood test that will allow clinicians to distinguish between these two types of inflammation.' The researchers have filed a patent in association with their findings and are thought to be attempting to develop a rapid diagnostic test for sepsis.

Dr Daniel Henning of the division of emergency medicine at the University of Washington said of the work: 'Overall, the study shows promise for new diagnostic modalities for a common and costly disease. The actual use of gene expression to determine the presence of infection in a clinical setting still has a way to go, however.'

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IDEXX Launches Canine Influenza Test Targeting H3N2 in Response to Outbreak

IDEXX Laboratories, Inc. announced that the company has developed, validated and made available a new test for the detection of H3N2 canine influenza virus. An avian-origin H3N2 strain identified in Asia around 2006 was determined to be the cause of a recent widespread canine influenza outbreak in the Chicago area. This highly contagious strain had previously been reported only in Asia but is now spreading among the dog population in the U.S. The IDEXX RealPCR Laboratory recently confirmed cases in the following states: Alabama, California, Texas, New York, Iowa, Michigan, Wisconsin and Indiana, in addition to the outbreak in the Chicago area.

As soon as the H3N2 strain was reported in the U.S., IDEXX invested in research and development and in less than four weeks produced and validated a test to detect the H3N2 strain. The new H3N2 Influenza Virus RealPCR Test allows rapid, reliable and specific testing for the strain responsible for the outbreak. IDEXX has added the H3N2 Influenza Virus RealPCR Test to existing IDEXX Comprehensive Canine Respiratory Disease (CRD) RealPCR panels at no additional cost to customers. The H3N2 test is also available as a stand-alone test.

"The rapid development of the H3N2 Influenza Virus RealPCR Test underscores our industry-leading investment in pet health innovation and demonstrates that diagnostics are central to pet health care and veterinary medicine," said Jonathan W. Ayers, president and chief executive officer of IDEXX Laboratories. "The test will dramatically increase the speed and accuracy of H3N2 influenza diagnosis in the United States. We're adding it to all Comprehensive Canine Respiratory Disease (CRD) RealPCR panels offered by IDEXX Reference Laboratories in order to help contain this highly contagious disease and as part of our commitment to helping pets live long, happy lives."

H3N2 influenza causes cough, fever, lack of appetite, weight loss and interstitial pneumonia and can be fatal. The signs of this illness in dogs are cough, runny nose and fever; however, some dogs are asymptomatic. Canine influenza also can impact cats.

"In response to the H3N2 outbreak, our team of infectious disease specialists mobilized, developed and validated a new test in less than one month, specifically for identifying H3N2," said Christian Leutenegger, DrVetMed, PhD, FHV, head of PCR molecular diagnostics at IDEXX Reference Laboratories. "We have developed an accurate diagnostic for this canine influenza strain to ensure that veterinary practices across the country are equipped with the tools they need to provide the best possible care to their patients and to help contain this outbreak and keep it from spreading further in the United States."

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Vivione Biosciences Inc. Announces Research Collaboration With Northwestern U School of Medicine

Vivione Biosciences Inc. ("Vivione" or the "Company") (VBI), is pleased to announce a research collaboration with Northwestern University Feinberg School of Medicine located in Chicago, Illinois. The collaboration will focus on the rapid detection of low levels of bacteria in clinical blood samples, as well the quantitative assessment of immune biomarkers related to sepsis. Working with Dr. Richard Wunderink in the Division of Pulmonary and Critical Care Medicine, the aim of this collaboration is to assess the performance of Vivione's RAPID-B bacterial detection system for detection of blood stream infections, where speed and high sensitivity are of particular importance.

"Working with a leading researcher in the area of infectious disease diagnostics like Dr. Rich Wunderink is a great step for Vivione. Dr. Wunderink's interest in quantitative bacterial detection for blood is a perfect next step in our clinical development of RAPID-B and sets the stage for the addition of rapid antimicrobial susceptibility testing using our platform's unique capabilities," said Vivione's Chief Medical Officer, Matthew Gombrich, M.D., M.S. "This test data will allow us to continue working in the rapid bacterial detection and sepsis testing markets establishing Vivione as a leader in infectious disease diagnostics," Gombrich continued. "Currently bacteremia and sepsis diagnostics represent a $4 billion market worldwide, and the predominant culture-based procedures take 12 to 24 hours on average to confirm the presence of bacteria, and an additional 24 to 48 hours to determine the subject bacteria's susceptibility to selected antibiotics. We believe that the RAPID-B system can combine these steps, shorten the detection period to under 7 hours, and yield more quantifiable results in the process."

Dr. Wunderink commented, "The need for more rapid assessment of bacterial presence in normally sterile body fluids such as blood, urine, and bronchial lavage fluid is well established and is vital to addressing the growing problem of antibiotic resistant bacteria. We're looking forward to assessing RAPID-B in this context, as well as the additional rapid antibiotic susceptibility profiling to determine the clinical utility of Vivione's platform."

"The involvement of a world-class academic center like Northwestern is further evidence of the growing interest in Vivione's RAPID-B platform. This collaboration strengthens the company's clinical development foundation and advances its strategic focus on infectious disease and sepsis," said Vivione CEO, Kevin Kuykendall. He continued, "Dr. Wunderink's academic and clinical reputation speaks for itself in the area of infectious disease and critical care medicine. Vivione could not think of a better collaborator as we move towards commercializing the RAPID-B platform in the clinical marketplace."

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Vivione Biosciences Finalizes Agreement With U of Rochester for Worldwide Rights to Novel Infectious Disease-Related Biomarker

Vivione Biosciences Inc., announced today the execution of an Option Agreement with the University of Rochester to gain exclusive worldwide rights to a novel biomarker for infectious disease-related diagnostics. This acquisition is one of many steps Vivione is taking to strategically position the company's entry into the clinical diagnostics market. Through the Option Agreement, Vivione will also have the ability to obtain exclusive worldwide rights to a therapeutic peptide targeting the same molecule identified by the biomarker. During the option period, Vivione will work with researchers at the University of Rochester in the Departments of Immunology and Pulmonology in order to expand upon existing data in clinical patient populations.

Matthew Gombrich, Chief Medical Officer at Vivione said, "Published data in the journal, Blood, (as well as non-published internal data at the University of Rochester) points to overexpression of this biomarker as being an excellent indicator to help clinicians define a population of patients with increasing toxicity related to infectious disease. The added prospect of combining the therapeutic peptide, which showed a dramatic improvement in mortality in animal models, with the diagnostic test, offers an incredible opportunity for the company to address the needs of critically ill patients. The fact that we will be able to develop a combined theranostic application will only strengthen our position as we begin moving through the clinical regulatory process."

Vivione's Chief Executive Officer, Kevin Kuykendall, said, "We continue to position our RAPID-B flow cytometric platform as a viable solution in clinical microbiology for use in pathology labs aiding in the rapid detection of serious infections. The addition of the University of Rochester's biomarker on our platform could be the catalyst that launches Vivione as a leader in infectious disease diagnostics. We could not have found a better partner to help us in expanding our clinical assays than the University of Rochester. Their commitment to excellence and their willingness to provide the clinical research needed to expand the patient population data gives us the confidence necessary to move this test into our clinical pipeline and establish Vivione as a leader in the multi-billion dollar infectious disease market."

Scott Catlin, Associate Vice President for Technology Commercialization at UR Ventures, added, "The University of Rochester is pleased to partner with Vivione Biosciences. We hope this collaboration will lead to earlier detection and more effective treatment of deadly infections."

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PositiveID Expands Testing of Firefly Dx PCR Chip to Food Safety Market, Detecting E. coli in Less Than 20 Minutes

PositiveID Corporation, a developer of biological detection and diagnostics solutions, today announced that it has successfully detected Escherichia coli (E. coli) bacteria on the PCR (polymerase chain reaction) chip of its Firefly Dx prototype handheld, real-time PCR pathogen detection system, in less than 20 minutes.

E. coli is a common pathogen that can cause diarrhea or other illness outside of the intestinal tract. The types of E. coli that cause diarrhea can be transmitted through contaminated water or food, or through contact with animals or people. These toxin-producing bacteria are called Shiga toxin-producing E. coli ("STEC"). According to the U.S. Centers for Disease Control, an estimated 265,000 STEC infections occur each year in the United States. Some types of STEC can cause severe disease, including bloody diarrhea and hemolytic uremic syndrome, which is a type of kidney failure that can lead to death.

Firefly Dx is designed to provide real-time, accurate diagnostic results in a handheld device, thereby leading to treatment scenarios at the point of need that are not possible with existing systems, which require lab-based equipment and can take hours or even days to provide results. Firefly's applications include point-of-need, lab-quality, detection of pathogenic organisms; agricultural screening in both domestic sectors and developing countries; and detection of biological agents associated with weapons of mass destruction.

"We are developing Firefly Dx to solve the critical need for rapid, portable, pathogen detection using real-time PCR within multiple markets including food safety, human infectious disease and clinical diagnostics, among others," stated William J. Caragol, Chairman and CEO of PositiveID. "We are very pleased with our progress to date on the development of Firefly Dx and are continuing our testing on the PCR chip to detect additional pathogens in less than 20 minutes."

By 2019, the global market for food safety testing is projected to reach more than $15 billion, and the North American food safety testing market is projected to grow from $3.7 billion in 2012 to $5.6 billion in 2018, according to MarketsandMarkets. In 2012, pathogen testing dominated the food safety testing market.

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UC Irvine Receives $5 Million to Advance Bloodstream Infection Detection Technology

A UC Irvine research team will receive up to $5 million to further develop a bloodstream infection detection system that speeds up diagnosis times with unprecedented accuracy – allowing physicians to treat patients with potentially deadly ailments more promptly and effectively. The five-year federal award is part of a ​National Institute of Allergy & Infectious Diseases program to fund nine institutions that will create tools to identify certain pathogens that frequently cause infections in healthcare settings – especially those that are resistant to most antimicrobials.

Advancing the development of quick and innovative diagnostic tests for identifying resistant bacteria is a key goal of President Barack Obama’s National Action Plan for Combating Antibiotic-Resistant Bacteria (pdf).

Led by Weian Zhao, assistant professor of pharmaceutical sciences, the UCI effort will employ his recently created Integrated Comprehensive Droplet Digital Detection system (IC 3D). In as little as 90 minutes, it can detect bacteria in milliliters of blood with single-cell sensitivity; no cell culture is needed.

“Rapid, precise diagnostics is vitally important to limit the spread of infections in the healthcare environment and to provide patients the prompt and exact treatments they need,” Zhao said. “In addition, this is an important part of meeting the president’s goal of personalized medicine. At the heart of this goal is giving the right patient the right drug at the right time. With rapid detection technology like IC 3D, this can be achieved.”

The IC 3D device will be used at UC Irvine Medical Center to identify in blood samples such antibiotic-resistant bacteria as extended spectrum beta-lactamase-producing Enterobacteriaceae, carbapenem-resistant Enterobacteriaceae, methicillin-resistant Staphylococci aureus and vancomycin-resistant Enterococci.

The clinical effort will be headed by Dr. Susan Huang, UCI professor of medicine and medical director of epidemiology and infection prevention, and Ellena Peterson, a UCI professor of pathology who oversees the clinical microbiology lab at UC Irvine Medical Center.

Bloodstream infections are a major cause of illness and death. In particular, infections associated with antimicrobial-resistant pathogens are a growing health problem worldwide. According to the Centers for Disease Control & Prevention, more than 2 million people a year in the U.S. get antibiotic-resistant blood infections, causing about 23,000 deaths.

“The mortality rate for blood infections is due, in part, to the inability to rapidly diagnose and treat patients in the early stages,” said Huang. A nationally recognized infectious diseases expert, she helps lead a CDC research program to develop and test innovative approaches to reducing infections in healthcare settings.

“This new technology will help advance early therapy,” she said. “It will have the potential to increase the survival of patients who are ill due to antibiotic-resistant pathogens.”

The IC 3D technology differs from other diagnostic techniques in that it converts blood samples directly into billions of very small droplets. Fluorescent DNA sensor solution infused into the droplets detects those with bacterial markers, lighting them up with an intense fluorescent signal.

Zhao noted that separating the samples into so many small drops minimizes the interference of other blood components, making it possible to directly identify target bacteria without the purification typically required in conventional assays.

A patent application has been filed by the University of California for the IC 3D technology, which has been optioned by Velox Biosystems, a startup company founded by Zhao to commercialize the product.

Other participants from UCI are Enrico Gratton, professor of biomedical engineering and director of the Laboratory for Fluorescence Dynamics; Michelle Digman, assistant professor of biomedical engineering; and Dong-Ku Kang, a pharmaceutical sciences project scientist.

The team will also work with industrial partners ISS Inc., Dolomite Microfluidics and BioVenture Services LLC to further develop and validate the IC 3D system and to modify the product with an eye toward future clinical approval.

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