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

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May 2009: Volume 35, Number 5

FDA Approves Two Hologic HPV Tests

Two new tests that can identify multiple types of the human papillomavirus (HPV) have received premarket approvals from FDA. Cervista HPV 16/18, the first HPV genotyping test to receive FDA approval, will enable providers to detect types 16 and 18 of the HPV virus—the two most oncogenic forms responsible for approximately 70% of all cervical cancers in the US. Cervista HPV HR (high-risk) test, the first new high-risk HPV DNA test to be approved in a decade, detects 14 high-risk types of HPV known to cause cervical cancer. Both tests work in similar manners by detecting the DNA sequences of these types of HPV. The two tests are intended to be used together for women age 30 and older, or women with borderline cytology, as a complete risk assessment for cervical disease. Women can also be tested occasionally to see whether dangerous strains have been cleared, which can lower the risk of cervical cancer. Cervista HPV 16/18 and Cervista HPV HR are manufactured by Madison, Wis.-based Third Wave Technologies, a wholly-owned subsidiary of Hologic. Hologic is the second company to gain FDA approval to sell a molecular diagnostic for HPV, following Qiagen’s HPV molecular diagnostic assay.

Qiagen Blood Collection, Purification System Cleared

Qiagen has received marketing clearance from FDA for the automation of the PAXgene Blood RNA System on the QIAcube. This clearance allows labs to automate an IVD purification method that is part of an integrated IVD blood collection method for intracellular RNA. The PAXgene Blood RNA System is currently the only collection, stabilization, and purification method, either automatic or manual, available in the US for IVD use, and the only product designed to stabilize whole blood in the tube at the point of collection with FDA marketing clearance. The automated system allows clinicians to obtain a gene expression profile or gene expression signature.

FDA Issues Draft Guidance on Donor Screening

FDA has released a draft guidance recommending that facilities which manufacture whole blood and blood components intended for transfusion use an FDA-approved donor screening test system for the detection of antibodies to Trypanosoma cruzi, the agent responsible for Chagas’ disease. Chagas’ disease is a tropical parasitic disease that usually spreads through blood-sucking insects, but can also be spread through blood transfusions. This guidance document does not apply to source plasma. FDA is looking to discuss the public health benefit of implementing selective testing of repeated donors as an alternative to testing all donations. Under such a scenario, all first time donors and any repeat donors not previously tested would have a licensed ELISA performed on their current donation. The guidance is available online, and FDA is accepting comments until June 24, 2009.

BD Receives Clearance for Chlamydia, Gonorrhea Assays

BD Diagnostics has received 510(k) clearance from FDA for two new assays for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae. These two new assays, the BD Probe Tec CT Qx Amplified DNA Assay and the BD Probe TEC GC Qx Amplified DNA Assay, are cleared for use on the BD Viper System with XTR Technology.