OraSure and Roche Sign Commercialization Agreement for Oral Fluid DOA Assays

OraSure Technologies Inc and Roche Diagnostics announced that the companies have signed an agreement for the worldwide commercialization of homogeneous fully automated oral fluid drugs of abuse assays with OraSure’s Intercept® oral specimen collection device. The oral fluid assays use Roche’s kinetic interaction of micro-particles in solution (KIMS) technology and are being jointly developed under an agreement previously signed by the parties. The oral fluid assays are designed to run on various clinical chemistry automated analyzers, which is intended to allow oral fluid samples to be processed with the same efficiency as current fully automated urine-based drug tests.

“We are very pleased with our joint development effort with Roche and the finalization and execution of the commercialization agreement associated with these important drugs of abuse assays. This relationship leverages Roche’s industry leadership in lab instrumentation and reagent chemistry and our leadership in oral fluid technology and sample collection devices,” said Douglas A. Michels, president and CEO of OraSure Technologies. “We look forward to working with Roche to bring these new assays to market, where they will have an immediate and positive impact on laboratory efficiency for drugs of abuse testing.”

“We are very pleased to be collaborating with OraSure Technologies in the development and commercialization of fully automated oral fluid drugs of abuse assays,” said Dirk Ehlers, head of Roche Professional Diagnostics. “This partnership leverages the strengths and experience of both companies and will enable us to deliver on our global commitment to providing best-in-class high-throughput oral fluid drug testing solutions.”

Developed and manufactured by OraSure Technologies, the Intercept® device is the only FDA-cleared in vitro diagnostic laboratory-based oral fluid testing system used for detecting commonly abused drugs such as marijuana, cocaine, opiates, PCP, and amphetamines (including methamphetamine and ecstasy) and for detecting barbiturates, methadone, and benzodiazepines. Intercept® is currently being used in workplaces, drug treatment and criminal justice testing markets, as well as in public school systems.

Source: OraSure Technologies Inc

Idaho Technology Begins FDA Clinical Trials for FilmArray Respiratory Panel

Idaho Technology Inc (ITI) announced that clinical trials of the FilmArray™ Respiratory Panel (RP) have commenced at three US hospital laboratories. The FilmArray RP is a user-friendly multiplex PCR platform capable of detecting 21 common respiratory viruses and bacteria. The FilmArray RP includes integrated sample preparation, requires only 5 minutes of hands-on time, and reports results in less than 1 hour.

“We believe that the FilmArray RP holds tremendous potential for hospital clinical laboratories frustrated with the hassle, long turnaround times, and inferior sensitivity and specificity of viral culture, DFA, and rapid flu tests. The FilmArray RP is a powerful molecular diagnostic assay designed for comprehensive detection of common respiratory pathogens and yet is still incredibly simple and easy to use,” said Kirk Ririe, CEO of Idaho Technology. “Beginning these clinical trials represents a significant milestone in the development of the FilmArray, which we anticipate will soon become ITI’s flagship technology.”

The clinical trials will be conducted at Children’s Medical Center, in association with UT Southwestern Medical Center, Dallas; Detroit Medical Center, Detroit; and The Medical University of South Carolina, Charleston.

Source: Idaho Technology Inc

FDA Clears Phadia’s Allergy Test, ImmunoCAP Rapid Reader II

Phadia announced that the FDA has cleared the ImmunoCAP® Rapid Reader II, a part of the ImmunoCAP Rapid System, used to aid in the diagnosis of allergy in the physician’s office.

This clearance allows Phadia to begin marketing the ImmunoCAP Rapid System to physicians throughout the United States who have laboratories that meet CLIA standards for Moderately Complex testing. The test requires a simple capillary blood draw, and test results are available to the physician in 20 minutes.

Up to 90% of all pediatric asthma patients have allergies, and up to 60% of adult asthma patient have allergies that trigger their asthma attacks. Reducing exposure to these allergens is a key recommendation of the NIH-funded National Asthma Education and Prevention Program and is an important step in the effective management of allergic asthma.

David Esposito, president of Phadia US, said, “The development of ImmunoCAP Rapid represents the continued evolution of Phadia’s leadership in in vitro allergy testing. With quick results available while the patient is still in the office, doctors will be able to help their patients better understand their allergic triggers which are common in respiratory diseases such as asthma and rhinitis.”

Source: Phadia

Linden Acquires Hycor Biomedical from Agilent Technologies Inc

Linden LLC, a Chicago-based health care private equity firm, announced it has acquired Hycor Biomedical Inc from Agilent Technologies Inc. Hycor develops, manufactures, and markets in vitro diagnostic products for the global allergy, autoimmune, and urinalysis markets. Agilent acquired Hycor through its acquisition of Stratagene in 2007. The terms of the agreement were not disclosed.

Founded in 1981 and based in Garden Grove, Calif, Hycor is a global manufacturer and marketer of in vitro diagnostics products. A series of acquisitions since its founding have expanded the company’s presence into urinalysis, allergy and autoimmune products used in clinical laboratories, hospitals, and doctors’ offices worldwide. Among its products, Hycor markets the HYTEC, KOVA, and AUTOSTAT brands. The company is focused on delivering products that provide the highest value to clinicians through innovation, reliability, and customer service.

“We believe Hycor has great opportunities outside of the Agilent portfolio,” said Nick Roelofs, president of Agilent’s Life Sciences Group. “Hycor is an innovative, profitable, and growing business, but it does not fit the core focus of our life science business. Agilent is pleased that Linden is the buyer because of its strong health care and diagnostics expertise coupled with its track record of investing in and growing businesses.”

Source: Linden LLC

Biomarker Could Help Doctors Tailor Treatment for Rheumatoid Arthritis

Investigators have identified a biomarker that could help doctors select patients with rheumatoid arthritis who will benefit from therapy with drugs such as Enbrel, a tumor necrosis factor (TNF)-antagonist drug. The study, led by researchers at Hospital for Special Surgery in collaboration with rheumatologists at University of Southern California, appears in the February issue of the journal Arthritis & Rheumatism.

“While our study was performed on a relatively small group of patients and will need to be confirmed in a larger cohort, the data are promising and may be clinically significant for the medical management of patients,” said Mary K. Crow, MD, director of Rheumatology Research and co-director of the Mary Kirkland Center for Lupus Research at Hospital for Special Surgery. “Treatment with these drugs is very expensive; the drugs can cost around $16,000 or so per year. If you are going to use them, you would like to know that they are likely to work in your patient.” Other well-known TNF-antagonists include Humira and Remicade.

The investigators found that patients with higher baseline levels of type I IFN were more likely to respond to therapy with TNF antagonists. Patients who had an increased IFN-beta/alpha ratio, meaning they had more IFN-beta, were also more likely to respond to therapy. They also observed significantly higher baseline levels of IL-1Ra in plasma samples from good responders as compared with those from nonresponders or moderate responders.

Source: Hospital for Special Surgery

Celerus Diagnostics Demonstrates Automated Rapid ISH

Through collaborative efforts with multiple industry partners, Celerus Diagnostics has successfully demonstrated Rapid ISH™ (in-situ hybridization) on its forthcoming Wave RPD System. In-situ hybridization uses a labeled complementary DNA or RNA strand to localize a specific sequence in a section of tissue. This is distinct from immunohistochemistry, which localizes proteins in tissue sections.

“The combination of onboard heating and our proprietary Wave technology has dramatically improved hybridization efficiencies for ISH assays,” said Marc Key, chief scientific officer.

“We’ve had success with both fluorescent and chromogenic markers,” said Jason Lusk, vice president of business development. “This is significant because the importance of molecular targets as companion diagnostics to identify patients for drug therapies continues to grow.”

Celerus Diagnostics will launch the Wave RPD System, a totally automated immunohistochemistry (IHC) and in-situ-hybridization staining system, to the market this year. The new system will be introduced at the United States and Canadian Association of Pathologists annual meeting being held in Washington DC, March 22–24. In 2008 Celerus Diagnostics introduced Rapid IHC® with its Wave System, a semiautomated platform that delivers high-quality IHC results in 15 minutes. The addition of onboard pretreatment steps to the existing 15-minute staining protocols results in totally automated IHC in 1 hour, compared to industry standards of 2½ to 4 hours. “The combination of onboard heating and our proprietary Wave technology has dramatically improved hybridization efficiencies for ISH assays,” Key said.

Source: Celerus Diagnostics

Research and Markets: 2010 Worldwide Medical Laboratories Industry Report

Research and Markets has announced the addition of the “2010 Worldwide Medical Laboratories Industry Report” to its offering.

The report, published annually, contains timely and accurate statistics, forecasts, and demographics. It features 2010 current and 2011 forecast estimates on the size of the industry (sales, establishments, employment) for the 47 largest countries, such as Japan, China, India, Russia, Canada, Mexico, Brazil, Argentina, UK, France, Germany, Italy, and the United States. It also includes definitions; 5-year historical trends on industry sales, establishments, and employment; and estimates on up to 10 subindustries.

Industry Definition
NAICS 621511: Medical Laboratories. This industry comprises establishments primarily engaged in providing professional analytic or diagnostic services to the medical profession, or to the patient on prescription of a physician.


  • Medical laboratories
  • Pathological laboratories
  • Testing laboratories
  • Urinalysis laboratories
  • Bacteriological laboratories
  • Neurological laboratories
  • Biological laboratories
  • Ultrasound laboratories
  • Blood analysis laboratories
  • X-ray laboratories, including dental

Source: Research and Markets

Abaxis Inc (ABAX) Receives FDA 510(k) Clearance for a New Clinical Assay, C-Reactive Protein

Abaxis Inc, a medical products company manufacturing point-of-care blood analysis systems, announced that the FDA has granted 510(k) marketing clearance of the new C-Reactive Protein (CRP) assay when used by health care professionals in conjunction with the Piccolo Xpress™ point-of-care analyzer. As a result of this new FDA 510(k) approval, US health care professionals can now conduct on-site chemistry analysis in less than 12 minutes for many types of conditions, including infections, inflammatory diseases, tissue injury, and some neoplastic processes.

CRP is widely used as an indicator of inflammation or infection and will initially be made available to the US market on an acute care panel called MetLyte Plus CRP. The most common use of the CRP assay is by rheumatologists in the detection and treatment of rheumatoid arthritis, although the test has utility in the detection and treatment of other afflictions including colon cancer, non-Hodgkin’s lymphoma, fever from bacterial infections, atrial fibrillation, and osteomyelitis. Abaxis is also investigating other configurations of tests along with CRP that may have additional utility to physicians at the point of care.

“With the addition of the CRP assay, Abaxis continues to add valuable specialty tests to its already broad general chemistry menu offering,” said Clint Severson, chairman and CEO of Abaxis Inc. “Our technology has the ability to perform a wide variety of tests, and our rich R&D pipeline continues to accelerate the Piccolo platform far beyond any other point-of-care device. As the Piccolo test menu expands, physicians will be able to do more on-site, leading to improvements in patient care, practice efficiency, and profitability.”

Source: Abaxis Inc

AspenBio Pharma Enters Development/Supply Agreement for AppyScore Reader

AspenBio Pharma Inc announced that it has entered into a strategic relationship with LRE Medical GmbH (LRE) to complete commercial development and manufacture of the reader instrument to be used with the AppyScore™ cassette system.

“We are fortunate to be working with LRE, who brings over 40 years of experience in medical device manufacturing and has built a successful track record in developing instruments currently in use in emergency and critical care settings,” said Daryl J. Faulkner, CEO of AspenBio Pharma. “LRE provides AspenBio with a proven instrument platform to commercialize our novel assay and strengthens an important part of our supply chain.”

The ELISA format of the AppyScore test is currently in clinical trials for clearance by the FDA and is designed to aid in the evaluation of patients suspected of having acute appendicitis. In addition to the ELISA format, the company has been developing a cassette and instrument format of the test, which will also require separate regulatory clearance prior to commercialization. Under the terms of the agreement, LRE will be the exclusive manufacturer of the instrument and will be responsible for providing the required manufacturing capacity and quality standards necessary to meet global market demands.

Source: AspenBioPharma Inc

AACE Approves New Diagnosis for Diabetes

The American Association of Clinical Endocrinologists (AACE) has approved the use of A1C as an additional diagnostic criterion for type 2 diabetes. An A1C of 6.5 or greater is now considered an alternate criterion for the diagnosis of type 2 diabetes.

“Using A1C will provide doctors and patients a convenient additional tool to diagnose diabetes and thereby identify more patients with it,” said Jeffrey R. Garber, MD, FACP, FACE, president of AACE. A1C is a test that is used to determine the average level of blood glucose over a prior 3-month period. It is currently used to measure glucose control in patients already diagnosed with diabetes. The test requires a single blood draw, and the results can be available the same day.

The most common criteria currently used to diagnose diabetes are a fasting glucose of 126 or greater or a 2-hour value on a glucose tolerance test (GTT) greater than 200. Both tests require patients to fast for a minimum of 8 hours prior to being tested. The GTT is a 2-hour series of glucose levels following the administration of a large amount of glucose.

Source: AACE