American Association for Clinical Chemistry
Better health through laboratory medicine
November 2009 Clinical Laboratory News: News from the FDA

CLN Banner Logo

November 2009: Volume 35, Number 11

Diagnostic Hybrids Flu Kit Cleared

Diagnostic Hybrids received 510(k) clearance of its D3 FastPoint L-DFA Respiratory Virus Identification Kit, which allows for the detection of influenza A, influenza B, respiratory syncytial virus, human metapneumovirus, adenovirus, and parainfluenza viruses from a patient specimen in under 30 minutes. The kit uses the same fluorescent labeling technologies as the company’s D3 Ultra and D3 Duet product lines in combination with newly developed L-DFA processing technology.

HIV Donor Screening Assay Approved

Abbott announced that it has received approval from FDA for its Prism HIV O Plus test, the first fully automated blood screening test for HIV-1/HIV-2. The test can be used to screen donors of blood and plasma for antibodies to HIV type 1 Groups M and O (anti-HIV-1) and type 2 (anti-HIV-2), and as an aid in the diagnosis of HIV-1/HIV-2 infection. The assay provides labs with a fully automated test capable of processing 160 samples per hour on the Abbott Prism system. With this approval, Abbott now has a complete panel of hepatitis and retrovirus tests available on the Prism system.

FDA Commissions IOM to Study Premarket Clearance Process

FDA announced that the Institute of Medicine (IOM) has been commissioned to study the premarket notification program used to review and clear certain medical devices marketed in the U.S. As part of the study, IOM will assemble a committee to investigate whether the current 510(k) process protects patients and promotes innovation that supports public health, and what changes are necessary to achieve these goals. The $1.3 million review is scheduled to be completed in 2011.

Cepheid’s Thrombophilia Gene Test Cleared

A new test developed by Cepheid to detect genetic variations associated with thrombophilia received 510(k) clearance. The Xpert HemosIL FII & FV test detects Factor II and Factor V Leiden genetic variations that can lead to an increased risk for blood clots. The test produces results in just over 30 minutes using a single GeneXpert cartridge. Although developed and manufactured by Cepheid, the test will be available worldwide through a partnership with Instrumentation Laboratory, the exclusive distributor of the test.

Meridian, Quidel Cleared to Update Flu Test Labels

Two rapid flu tests used to detect the 2009 H1N1 virus have been granted special 510(k) clearance for updated labeling claims. Meridian Bioscience will update its TRU FLU package insert to include analytical sensitivity claims for two strains of the 2009 H1N1 virus cultured from respiratory specimens, and Quidel will update its QuickVue Influenza A+B test package insert to include reactivity with culture isolates of the 2009 H1N1 Influenza A virus. Although the performance characteristics of either test in regard to the 2009 H1N1 virus have not been established, the analytical sensitivity claims add an additional product benefit. Both tests have been used to distinguish between influenza A and B viruses.

Nanosphere Cleared for New Respiratory Virus Test

FDA 510(k) clearance has been granted to Nanosphere for its Verigene Respiratory Virus Nucleic Acid Test and the Verigene SP System. The test detects influenza A and B and the respiratory syncytial virus, and the Verigene SP System provides automated molecular diagnostics capabilities in a multiplexed, random-access, modular system using the same imaging technology as the first generation Verigene system. The platform is intended for both molecular and microbiology labs.

Ovarian Cancer Test Cleared

Vermillion’s ovarian cancer test, OVA1, received FDA clearance as an aid in determining if a woman is at risk for a malignant pelvic mass prior to surgery. The new blood test is the first FDA-cleared test that can indicate the possibility of ovarian cancer with high sensitivity prior to biopsy or surgery, even if radiological tests fail to indicate a malignancy. An in vitro diagnostic multivariate index test, OVA1 combines the results from five immunoassays using an algorithm to produce a single score indicating the chance of a malignancy. Quest Diagnostics participated in development of the test and retains exclusive rights to offer it to the clinical reference lab market within the U.S. for 3 years.

Anti-HIV Test Receives FDA Approval

Ortho Clinical Diagnostics received FDA approval for its VITROS Anti-HIV 1+2 Assay on the VITROS 5600 Integrated and VITROS 3600 Immunodiagnostic Systems. The assay is designed for the qualitative detection of HIV 1+2 in human serum and plasma and can be used by physicians as a quick HIV test or to screen pregnant women to identify neonates at high risk of acquiring HIV. This is the first HIV diagnostic assay approved for an integrated system in the U.S., allowing labs to run HIV and other tests on a single testing platform. Since 2008, OCD has released 112 assays for the VITROS systems.