Quidel Receives FDA Clearance for Its New Solana Molecular System and Assay for Diagnosis of Group a Streptococcal Infections

Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market Quidel's new instrumented molecular system -- Solana -- and for the Solana Group A Strep Assay (Solana GAS Assay) for the rapid, qualitative detection of β-hemolytic, Group A Streptococcus (Streptococcus pyogenes) nucleic acids isolated from throat swab specimens from patients with signs and symptoms of pharyngitis, such as sore throat.

The Solana molecular platform leverages the Helicase-Dependent Amplification (HDA) technology that is resident in Quidel's AmpliVue® molecular product line to generate a fast and accurate test result. Solana can process up to 12 patient samples in each 30-minute run, thereby providing time-saving workflow advantages to healthcare professionals in moderately complex settings.

The Solana Group A Strep Assay is an easy-to-use, rapid molecular diagnostic test that has superb clinical accuracy and does not require culture confirmation of negative results. The assay requires no upfront extraction of DNA and generates an accurate result in approximately 30 minutes.

Group A streptococci are Gram-positive bacteria, primarily residing in the nose, throat and skin; these bacteria are responsible for several illnesses, ranging from comparatively mild illnesses (e.g., strep throat, otitis media, or skin infections) to severe illnesses (e.g., necrotizing fasciitis and streptococcal toxic shock syndrome).(1) Strep throat (streptococcal pharyngitis) is the most common illness caused by Group A streptococcal infections. These bacteria are spread through contact with airborne droplets from an infected person's cough, sneeze or via contaminated items such as eating utensils.(2)

"We are very pleased to receive FDA clearance for the Solana system," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "We believe that Solana is uniquely positioned in the marketplace because it offers customers the ability to batch the more commonly-run assays, provides superb clinical accuracy, and can also serve as an elegant batch method for confirmation of rapid immunoassay results when needed."

With the 510(k) clearance of Solana, Quidel now offers three molecular platforms -- AmpliVue, Lyra, and Solana -- that are designed to meet the unique needs of customers in different market settings. Combined, they provide for the enhanced diagnosis of fourteen (14) different infectious diseases, including those caused by Influenza A, Influenza B, hMPV, RSV, Group A Strep, Groups C/G Strep, Group B Strep, C. difficile, Bordetella pertussis (whooping cough), adenovirus, parainfluenza virus, HSV 1, HSV2, and Trichomonas.

1. http://www.cdc.gov/groupAstrep/about/faqs.html
2. http://www.cdc.gov/Features/strepthroat/

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BacterioScan Wins Award for Design Excellence

BacterioScan Inc. a premier in vitro lab diagnostics company announced it’s third award of the year. The Medical Design Excellence Award (MDEA) winners were announced Wednesday night at a gala event recognizing significant advances in medical product design and engineering that improves the quality of healthcare delivery and accessibility. The celebration was held in conjunction with the MD&M East event, in New York. BacterioScan’s industrial design partner is MetaPhase (St. Louis, MO).

“The MDEA competition is a prestigious competition that fosters innovation by honoring the highest caliber medical devices on the market today and those who are dedicated to their development”, said Dana Marshall, President and CEO. Adding “it was an honor to work with our industrial design partners at Metaphase.

BacterioScan’s product platform is the worlds first rapid bacterial detection system that uses proprietary precision laser sensor, delivering phenotypic results that reduce the laboratories’ time-to-result by 95% for the vast majority of samples while reducing lab workload by more than 60%. BacterioScan’s advanced technology is also being developed to provide rapid detection of antibiotic-resistant bacterial infection, reducing the time for determining optimum treatment from several days down to a few hours, improving patient care, reducing the cost of effective treatment, and helping fight the emergence of bacterial infections that are resistant to antibiotics.

BacterioScan’s instruments and disposables are deployed globally for clinical studies within world-class institutions. “The core of this research is the rapid detection of antibiotic resistance and the precise determination of antibiotic susceptibility and patient-specific drug and dose concentrations for a variety of bacterial infections,” said Dana Marshall, BacterioScan President and CEO. “Initial work has clearly shown that our company’s technology can reduce the time to detect resistance from over 30 hours to less than two hours; this dramatic improvement in time-to-result can reduce antibiotic development time and costs as well as speed clinical trial enrollment; supporting the global need for antibiotic stewardship.

BacterioScan Inc. is an in-vitro diagnostics (IVD) company focused on the rapid detection and real-time quantification of bacteria in fluid using optical measurements. BacterioScan’s IVD platform can rapidly detect bacterial infections, determine resistance to a range of antibiotics, and provide clinicians with patient-specific guidance on the most rapid and cost-effective treatment plan. This phenotypic approach to early detection and targeted intervention support the global need for optimal, informed antibiotics usage and to control and monitor antimicrobial resistance. BacterioScan’s first medical device product is a compact, simple, and low-cost system for rapid detection of Urinary Tract Infection (UTI) for use in clinical microbiology labs. BacterioScan is a privately held global corporation with headquarters in St Louis, Missouri.

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OraSure Awarded $10.4 Million HHS Contract to Advance Rapid Ebola Test Clinical Development

OraSure Technologies, Inc., a leader in point of care diagnostic tests and specimen collection devices, announced that it has been awarded a contract for up to $10.4 million in total funding from the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response's Biomedical Advanced Research and Development Authority (BARDA) related to the Company's OraQuick® Ebola Rapid Antigen Test. The three-year, multi-phased contract includes an initial commitment of $1.8 million and options for up to an additional $8.6 million to fund certain clinical and regulatory activities.

The Company's rapid Ebola test utilizes the OraQuick® technology platform which is the same proven technology used in the Company's rapid HIV and HCV test kits.

"We believe that the availability of an accurate and simple rapid Ebola antigen test will be critical to containing and controlling current and future Ebola outbreaks," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "We are grateful to BARDA for making this funding available as it will enable us to complete key clinical activities and obtain important regulatory approvals for this product."

Earlier in the year, the Company announced that it had completed the design of a prototype device that appears to deliver analytical performance similar to laboratory PCR tests when evaluated on stored samples from infected patients. During the first quarter of 2015, the Company also recognized revenues from the initial sales of this product to the Centers for Disease Control and Prevention for investigational use in Africa. The data generated from this field testing, along with other clinical and non-clinical studies being performed, is expected to be used in an application to obtain Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) during the next several months. The Company continues to focus its efforts on securing sustainable product purchase commitments from both government and non-government sources.

OraSure has a highly successful track record for developing and commercializing point-of-care tests that address critical disease states. The Company has developed the only FDA approved rapid test for hepatitis C, the OraQuick® HCV Rapid Antibody Test, and the first FDA approved rapid test for HIV, the OraQuick ADVANCE® HIV-1/2 Antibody Test. The Company has also developed the first and only HIV test approved by the FDA for use by consumers, the OraQuick® In-Home HIV Test.

This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201500009C.

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REAGEN LLC Launches Rapid Elisa Tests for EHDV Detection in Cervids

REAGEN  EHDV Detection Kit is designed for the detection of Epizootic Hemorrhagic Disease (EHD) virus in cervids. EHDV is an orbivirus that infects most wild and domestic ruminants. EHD is endemic in many countries, particularly affecting white-tailed deer in North America, with a morbidity and mortality rate as high as 90%. Deer, elk, and moose can seroconvert. Edema, hemorrhage, and ulcerations are seen in the mouth and lips in the acute form of the disease. In the chronic form of the disease, affected animals exhibit sloughing of the hoof wall, erosions, and scars in the rumen. Spontaneous abortions and stillbirths have also been reported in some epidemics. Duration of viremia in wild ruminants is 15-40 days post infection, with peak viremia seen from 6 days post infection (titers greater than 106 pfu/ml) in experimental animals

The REAGEN EHDV Detection Kit provides a simple, rapid, sensitive and cost-effective enzyme-based immunoassay (ELISA) screening method for detectng EHDV from animal blood sample(serum or plasma) . Bluetongue virus (BTV), a member of the genus Orbivirus, produces similar symptoms, and differential diagnosis is important to prevent widespread outbreak and economic loss. The ELISA methodis specific, without cross-reactivity between the serogroups of BTV and EHDV.

REAGEN LLC is an indrustry-leading biomedical enterprise focused on designing and producing a broad range of ELISA kits, including clinical diagnostic kits, food and feed safety kits, and veterinary disease kits. we also manufacture microplate readers, plate washers, and related instruments and equipment.

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HHS Looks to Rapid, Point of Care Ebola Test

To assist doctors in diagnosing Ebola virus disease quickly, the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) will pursue development of an Ebola virus diagnostic test for use in a doctor’s office, hospital, clinic, or field setting that will provide results within 20 minutes.

“Fast and inexpensive point-of-care diagnostics will improve our ability to control Ebola virus disease outbreaks,” said Robin Robinson, Ph.D., director of ASPR’s Biomedical Advanced Research and Development Authority (BARDA), which will oversee this development program for HHS. “Faster diagnosis of Ebola virus infections allows for more immediate treatment and an earlier response to protect public health worldwide.”

Diagnosing Ebola virus infections quickly in resource-poor areas would enable health care providers to isolate and provide necessary treatment and supportive care to patients suffering from Ebola. Quickly isolating patients helps limit the spread of the disease. Emerging evidence has shown that early initiation of supportive care improves outcomes for patients suffering from Ebola virus disease.

The development of this simple, low-cost, lateral-flow test, called the OraQuick rapid Ebola antigen test, will take place under a $1.8 million contract with OraSure Technologies Inc., headquartered in Bethlehem, Pennsylvania. Lateral flow tests detect the presence of a virus with a drop of the patient’s blood or saliva on a test strip, similar to the tests used in doctors’ offices to diagnose strep throat.

The agreement supports clinical and non-clinical work necessary to apply for approval of the test by the U.S. Food and Drug Administration. The contract could be extended for up to a total of 39 months and $10.4 million.

In addition, OraSure will evaluate whether the test can be used in the post-mortem analysis of oral fluids. During the current epidemic, people died before Ebola virus infections could be confirmed, yet the bodies of people infected with Ebola virus would have remained highly infectious. A simple, rapid test that could determine disease status quickly from the body’s oral fluids would facilitate infection control efforts and support the appropriate handling of remains infected with the Ebola virus.

The OraQuick rapid Ebola antigen test is the first point-of-care Ebola virus testing device to receive BARDA support. To help the United States prepare for and control Ebola virus disease outbreaks, BARDA also is supporting development of vaccines to prevent Ebola virus infections and therapeutic drugs to treat the disease.

The new test is part of BARDA’s comprehensive integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear (CBRN) agents, pandemic influenza, and emerging infectious diseases.

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New Microscope Technique Could Speed Identification of Deadly Bacteria

Holographic microscope coupled with machine-learning software, which could be an inexpensive, point-of-care solution for hospitals and contamination screening of food industries worldwide, will be tested in Tanzania next month.

 new way of rapidly identifying bacteria, which requires a slight modification to a simple microscope, may change the way doctors approach treatment for patients who develop potentially deadly infections and may also help the food industry screen against contamination with harmful pathogens, according to researchers at the Korea Advanced Institute of Science and Technology (KAIST) in Daejeon, South Korea.

Described this week in The Optical Society (OSA) journal, Optics Express, the new approach involves bouncing laser light off individual bacteria under the microscope, creating holographic images of them, and then using a mathematical transformation and computer software to analyze the images and identify them by comparing them to other, known bacteria. The software uses a machine-learning algorithm — the sort computers connected to security cameras might use for automated facial recognition.

If the approach proves to be effective in controlled clinical trials, it could lead to a powerful new way of routinely and almost immediately identifying dangerous bacteria at the bedside — much faster than the days it normally takes to grow or "culture" the microbes in the laboratory from a patient's blood, which is still the gold standard in the health care industry for making a definitive diagnosis. Also routinely used today is a newer method for rapidly identifying bacteria based on a DNA-analysis technique called quantitative polymerase chain reaction (qPCR), but it still may take hours to return a result, and it requires expensive sample preparation that is often cost prohibitive for routine use in rural or resource poor settings around the world.

The challenge of meeting clinical needs in the developing world was one of the motivations behind the work, according to the KAIST team. They wanted to find an inexpensive method that could surpass the speed of qPCR.

"Employing laser holographic techniques, we achieved rapid and label-free identification of bacterial species at the single bacterium level with a single-shot measurement," said physicist YongKeun Park, who led the KAIST team. "This means the present method can be utilized as a prescreening test for point-of-care bacterial diagnosis for various applications including medicine and food hygiene."

"We have also developed a compact portable device, so called quantitative phase imaging unit (QPIU) (Optics Letters 39 (12), 3630-3633), to convert an simple existing microscope to a holographic one, in order to measure light scattering patterns of individual bacteria, which can then be used to identify bacteria species for rural areas and developing countries," said Park. "Our team has plans to go to Tanzania next month for a field test."

Why Speed Matters in Infection Control

In hospitals and clinics worldwide, bacterial infections are a major source of illness, often slowing recovery or making matters much worse for people who are admitted to inpatient care for routine or emergency treatment. In the most severe cases, bacterial poisoning causes severe disease and syndromes like sepsis, meningitis, pneumonia, and gastroenteritis — all of which can be deadly unless the patient is given immediate and appropriate treatment.

The true challenge of fighting those infections is time. In order to best treat their patients, doctors would like to know exactly which bacteria they are infected with, but the lost hours or days spent identifying the exact pathogen can make the road to recovery that much steeper. Sepsis, for instance, can develop so rapidly that mortality has been seen to increase by 9 percent per hour until treatment is given. Waiting two days may kill the patient, Park added.

For that reason, many hospital-acquired infections are treated presumptively, before they are definitively identified, using broad-spectrum antibiotics. These powerful combinations of potent drugs are often effective, but using them routinely raises the risk of deadly multidrug-resistant bacteria emerging.

The new QPIU technology promises to deliver better point-of-care diagnostics by reducing the time it takes to specifically identify bacteria, which may guide treatment, allowing doctors to prescribe the best drugs available to treat an infection and improving outcomes for people with hospital-acquired infections — though the effectiveness of the approach remains to be proven in future clinical trials.

In their initial experiments, Park and his colleagues showed as a proof of principle that they could identify bacteria with high accuracy. They examined four different bacterial species (Listeria monocytogenes, Escherichia coli, Lactobacillus casei, and Bacillus subtilis). The first three are all pathogens known to infect humans through the food chain or via hospital-acquired infections. The fourth is a harmless bacteria used in laboratory research but of great interest because it is closely related to the deadly Bacillus anthracis, which is the base for Anthrax.

Under a microscope, all four of these rod-like bacteria look nearly identical. They would be virtually impossible to distinguish. The KAIST team, however, sorted them using the QPIU process with an accuracy greater than 94 percent.

The technique involves scattering light off the bacteria under the holographic microscope and then applying a mathematical function known as a Fourier Transform to the holographic images. The Fourier Transform allows them to define a distinct, fingerprint-like light scattering pattern for any given bacterial cell. They then applied software they designed to the analysis, which used a conventional approach to statistical classification known as machine learning — a sorting strategy based on pattern similarities that has been extensively used in applications like facial recognition software. This was the first time anyone had applied machine learning to Fourier Transform light scattering data, Park said.

They are now looking to extend their initial work to see if they can distinguish between several types of bacterial subgroups — to identify the most drug resistant or virulent strains from the innocuous ones.

In addition to helping in the clinic, the new method may be useful in the food industry or for homeland security applications. In principle, the approach could be scaled up to screen for contaminated food or suspicious packages.

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UMass Food Scientist Wins Award for Rapid Pathogen Detection

A University of Massachusetts food science researcher has won an award for developing a method of rapid pathogen detection in food.

The researcher, Sam Nugen, engineered viruses to identify and separate microbial contaminants from food. His methods may help food manufacturers skip the wait time for safety test results before products can be sold, according to UMass.

The researcher has been named one of two winners of the 2015 Future Leaders Award from the International Life Sciences Institute’s North America. ILSI awards the two-year, $15,000 international award to promising nutrition and food scientists each year to conduct research that might not otherwise receive funding.

The Food Safety Modernization Act of 2011 shifted the Food and Drug Administration’s focus from responding to food contamination to preventing it, placing increasing pressure on food manufacturers to prove that their products are safe prior to shipping. Results from current testing methods, which involve sending a sample to a lab where a broth is prepared and any bacteria found are plated and grown, can take several days to a week. This adds to warehouse costs before shipping, according to a UMass press release.

“We’re working on separating bacteria from a food sample much more quickly, in minutes, so technologies that already exist for testing a clean sample can be used,” Nugen said in the release. “It should break the bottleneck in the system and save considerable time and expense.”

Nugen and his colleagues engineered viruses magnetized with cobalt nanoparticles, which can recognize and infect E. coli while separating it from a sample, according to the release. The infection changes the solution’s color, making the presence of E. coli known.

According to Nugen, about 46 percent of food-borne illness outbreaks come from fresh fruit and vegetables, which can’t be held in storage for testing without losing freshness and nutritional quality. According to the release, faster testing methods will make fresh produce safer for consumers.

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