American Association for Clinical Chemistry
Better health through laboratory medicine
June 2011 Clinical Laboratory News: News from the FDA

News from the FDA

First Clearance for Major Molecular Allergens

Siemens Healthcare Diagnostics has received FDA clearance for a total of 21 3gAllergy allergens assays that run on its IMMULITE 2000 Immunoassay System, including approval of eight new molecular allergens never before available in the U.S. The eight molecular allergens identify major allergenic proteins derived from cat and dog dander, house dust mites, Aspergillus (mold), and shrimp. These molecular allergens are intended to help physicians further identify patient sensitization to a specific protein component of an allergen, as well as differentiate whether symptoms are caused by a specific allergen or by cross reactivity.

Roche’s HPV Test for Cervical Cancer Approved

FDA has approved Roche’s cobas HPV (human papillomavirus) test designed to identify women at the highest risk for developing cervical cancer. The cobas HPV test is the only cervical cancer screening test that allows HPV 16 and 18 genotyping concurrently with testing for 12 other high-risk HPV types. HPV 16 and 18 are the two highest-risk HPV genotypes and are responsible for more than 70% of cervical cancers.

Wako’s Tests for Liver Cancer Risk Assessment Cleared

FDA has granted Wako Diagnostics 510(k) clearance to market its μTASWako i30 instrument with tests for alpha-fetoprotein L3 (AFP-L3) and des-gamma-carboxy prothrombin (DCP). The AFP-L3 and DCP tests aid in risk assessment for hepatocellular carcinoma in patients with chronic liver disease. 

Trichomonas Vaginalis Test Gets Nod

Gen-Probe has received FDA clearance to market its APTIMA Trichomonas vaginalis assay on the fully automated TIGRIS system. The APTIMA assay is the first amplified nucleic acid test to detect Trichomonas vaginalis, the most common, curable sexually transmitted infection in the U.S. The test can be used on clinician-collected endocervical or vaginal swabs, urine, and specimens in PreservCyt solution from symptomatic or asymptomatic women.

Test to Detect and Differentiate Influenza A/B, and H1N1 Cleared

Cepheid has received FDA clearance to market its Xpert Flu test. The molecular diagnostic test operates on Cepheid’s GeneXpert System and is designed to simultaneously detect and differentiate influenza A, influenza B, and the 2009 H1N1 influenza virus in 60 minutes.

Idaho Technology Respiratory Virus Panel Gets Green Light

FDA has granted Idaho Technology 510(k) clearance to market its FilmArray instrument and FilmArray Respiratory Panel, a multiplex nucleic acid test designed to simultaneously detect 15 respiratory viruses. The respiratory virus panel includes adenovirus, coronaviruses HKU1 and NL63, human metapneumovirus, influenza A and influenza A subtypes H1, H3, and H1 2009, influenza B, parainfluenza viruses 1, 2, 3, and 4, rhinovirus/enterovirus, and respiratory syncytial virus. The assay simultaneously tests for all the virus types in nasopharyngeal swabs collected from individuals suspected of respiratory tract infections.