August 2010 Clinical Chemistry News: FDA News

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August 2010: Volume 36, Number 8

FDA Focuses on DTC Genetic Tests

On the heels of a warning letter to Pathway Genomics that its Genetic Health Report home-use saliva collection kit required FDA regulatory review, FDA sent letters to five more direct-to-consumer test companies that offer genomic testing, questioning the legality of selling their products directly to customers without FDA review. Letters went out to Navigenics, 23andMe, Knome, and deCODE Genetics.

FDA highlighted statements on the Navigenics website that claim that the company’s tests can determine the effectiveness of certain medications for individuals, as well as provide information on the predisposition for “important health conditions and medication sensitivities.”

FDA also wrote to Illumina, manufacturer of the Infinium HumanHap550 array used by deCODE Genetics and 23andMe. FDA noted that the device is labeled for research use only, yet Illumina has knowingly provided the HumanHap550 array to 23andMe and deCODE Genetics for clinical diagnostic use without FDA review.

FDA offered to meet with each of the companies to discuss what they must do to comply with agency requirements.  The letters are available on the FDA website.

H1NI Emergency Use Status Terminated

FDA has revoked the emergency use authorizations for a number of molecular diagnostic tests that were previously cleared during the peak of the 2009 novel H1N1 influenza outbreak. According to the Department of Health Human Services, the number of new 2009 H1N1 cases has dropped to normal flu infection rates and there is no longer a need for a state of emergency. FDA indicated it is aware that a large number of labs have brought and are still using tests that were authorized for emergency use.

Molecular Test for Chlamydia and Gonorrhea Cleared

FDA has granted Abbott clearance to market a new, sensitive molecular diagnostic test and instrument to simultaneously detect gonorrhea and chlamydia, two of the nation's most widespread sexually transmitted diseases (STDs). Abbott received independent clearances for both the Abbott RealTime Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) assay and the Abbott m2000 System. Used together as a system to identify CT/NG infections, the new tests work with multiple specimen types, including urine, and urethral, vaginal, and endocervical swabs.

Green Light for First Rapid HCV Test

FDA has approved the first-ever rapid hepatitis C virus (HCV) test in the U.S. Manufactured by OraSure Technologies, the test produces results in 20 minutes and will aid in the diagnosis of more than 4 million Americans who are infected with HCV but not aware they have the disease. The test detects HCV antibodies in venous, whole-blood specimens. The availability of a rapid HCV test represents an important milestone because unlike HIV, HCV is curable, and early detection will help infected individuals receive life saving medical treatment and avoid unknowingly infecting others.


FDA Okays First Assay to Detect both HIV Antigen and Antibodies

FDA announced it has approved the first diagnostic assay that will help identify HIV antigen and antibodies, allowing healthcare practitioners to pinpoint HIV at its early stages in infected individuals and potentially save lives. The assay, manufactured by Abbott, is highly sensitive, and is intended as an aid in the diagnosis of HIV-01/HIV-2 infection in adults, including pregnant women. The assay is also the first that can be used to diagnose HIV-01/HIV-2 in children as young as 2 years.


FDA Clears Lactate Test for epoc System

OEpocal announced that FDA has given clearance to market its new lactate test on the epoc Blood Analysis System. Lactate measurements from the epoc System are used to assess acid-base status and for diagnosis and treatment of lactic acidosis, or abnormally high acidity in the blood. The addition of the lactate assay to the BGEM Test Card represents the second metabolite cleared for use on the epoc System, a point-of-care blood gas and electrolyte platform, in the past 12 months.


FDA Clears Tissue of Origin Test for FFPE

FDA has given the green light to Pathwork Diagnostics’ Tissue of Origin Test for formalin-fixed, paraffin-embedded (FFPE) tissues. FDA’s authorization enables the Tissue of Origin Test to be widely used on common clinical FFPE tumor specimens from both community and research hospitals and will help identify difficult to diagnose cancers. The Pathwork Tissue of Origin Test uses microarray-based RNA profiling to compare the patient’s specimen to a database of known tumor types. This clearance will also serve as a model for additional FFPE-based cancer tests on the Pathwork platform.

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