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

News from the FDA


Quest’s Influenza and Respiratory Virus Test Kit Cleared

Bio-Rad Laboratories and Axis-Shield have received FDA clearance for Bio-Rad’s BioPlex 2200 Anti-CCP test for the early detection of rheumatoid arthritis. The clearance also marks the test’s U.S. launch. The BioPlex 2200 Anti-CCP assay is based on Axis-Shield’s proprietary anti-CCP technology. The test runs on Bio-Rad’s BioPlex 2200 system and measures anti-cyclic citrullinated peptide antibodies, a biomarker that has shown to have superior specificity in diagnosing rheumatoid arthritis. 

Additional Claims Cleared for MRSA Test

Thermo Fisher Scientific has received FDA clearance for additional claims for its Spectra MRSA test, which is designed to check for methicillin-resistant Staphylococcus aureus(MRSA). Labs can now use the test for qualitative detection of MRSA from positive blood cultures demonstrating Gram-positive.

Ortho’s Intact Parathyroid Hormone Assay Gets Nod

FDA has given Ortho Clinical Diagnostics clearance to market its VITROS intact Parathyroid Hormone (iPTH) assay. The test measures intact parathyroid hormone levels and uses one protocol for both routine and intraoperative testing. Results are available in 18 minutes on the fully automated, random access VITROS ECi/ECiQ and 3600 Immunodiagnostic Systems.

ARK Diagnostics Finishes its 5-Test Menu of FDA-Cleared Assays

ARK Diagnostics, Inc. has received FDA clearance to market its ARK Gabapentin and ARK Lamotrigine Assays. These proprietary tests are designed to measure drug levels in serum or plasma and to aid in dosing decisions for personalized drug therapy. The clearance of these two tests completes ARK’s 5-test menu of FDA-cleared assays for newer generation anti-epileptic drugs (AEDs), which includes assays for levetiracetam, lamotrigine, topiramate, and zonisamide. 

Gen-Probe Submits Regulatory Application for Cervical Cancer Test

Gen-Probe has submitted a Premarket Approval Application (PMA) to the FDA for its APTIMA HPV (human papillomavirus) test. The new molecular test identifies high-risk HPV infections that are associated with cervical cancer and precancerous lesions.

FDA Approves Roche’s Second-Generation Hepatitis C Virus Test

Roche has received FDA approval for its real-time PCR Cobas TaqMan HCV test. The new test is designed to help clinicians monitor patients with HCV infections, as well as to improve treatment outcomes. The assay measures the amount of viral RNA in serum of infected individuals.