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

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October 2009: Volume 35, Number 10

FDA Publishes Draft Recommendations on HPV IVD Tests

FDA published draft guidance recommendations for studies evaluating the analytical and clinical performance of in vitro diagnostics for the detection of human papillomaviruses (HPVs), particularly those used in conjunction with cervical cytology to aid in the screening for cervical cancers. The guidance includes both devices that detect groups of HPV genotypes, especially high-risk HPVs, and those that detect more than one genotype of HPV and indicate which HPV genotypes are present. The guidance provides detailed information on the types of studies FDA recommends to support premarket approval of these devices. A copy of the guidance is available online.

Public Health Notification Released on Glucose Monitoring Technology

FDA recently released a public health notification warning consumers who take therapeutic products containing certain non-glucose sugars about the possibility of falsely elevated blood glucose results on glucose dehydrogenase pyrroloquinoline quinine (GDH-PQQ) test strips. These sugars may falsely elevate glucose results, masking hypoglycemia and leading to excessive insulin administration and the possibility of serious injury or death. Since 1997, FDA has received 13 reports of deaths associated with GDH-PQQ glucose test strips in which there was documented interference from maltose and other non-glucose sugars. Six of these deaths have occurred since 2008. FDA recommends avoiding use of GDH-PQQ glucose test strips in healthcare facilities and to never use these strips on patients receiving interfering products. A list of GDH-PQQ glucose test strips is available on the FDA website.

Nanosphere Submits Application for Respiratory Virus Assay

Nanosphere announced that it has submitted a 510(k) application to FDA for an influenza and respiratory syncytial virus (RSV) assay for its Verigene SP system, an automated, multiplexed, random-access, modular system for molecular diagnostics. The company also plans to submit additional FDA applications for each of its previously 510(k)-cleared assays for the Verigene SP system. These assays include a thrombophilia or hypercoagulation panel, a warfarin metabolism assay, and a cystic fibrosis panel.

510(k) Clearance Granted to Luminex Cystic Fibrosis Test

Luminex received 510(k) clearance from FDA for its new cystic fibrosis (CF) test, the xTAG Cystic Fibrosis 39 Kit v2. The newly cleared test can be used to screen potential parents to determine if they are carriers of CF gene mutations or as a confirmatory diagnostic for newborns and children. The xTAG Cystic Fibrosis 39 Kit v2 is the next generation of Luminex’s xTAG Cystic Fibrosis Kit that was first cleared by FDA in May 2005. The kit screens for 23 CFTR gene mutations and four variants recommended by the American College of Medical Genetics and American College of Obstetricians and Gynecologists, as well as 16 additional CFTR gene mutations.

H1N1 Test Approved for Emergency Use on U.S. Troops Overseas

FDA issued an Emergency Use Authorization (EUA) that allows a H1N1 influenza test developed by the CDC and manufactured by Biosearch to be used to detect the virus in troops serving overseas. EUAs allow the use of unapproved products or unapproved uses of approved medical products during declared public health emergencies. The Department of Defense plans to distribute the swH1N1 (swine) Influenza Real-Time RT-PCR test to qualified labs.