October 2010 Clinical Laboratory News: FDA News

FDA Approves First Automated Molecular Test for HBV

Abbott has received FDA approval to market an assay for measuring viral load, the amount of hepatitis B virus (HBV) in a patient’s blood. The Abbott RealTime HBV assay is the first and only FDA-approved test capable of automating HBV viral load testing from sample extraction to final results. The test provides sensitive measurement of HBV in human plasma or serum from individuals chronically infected with HBV and is designed for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy.

BD Gets Moderate Complexity Status for Group B Strep Assay

Becton Dickinson has received moderate complexity status from the FDA for its BD MAX GBS Assay for Group B Streptococcus (GBS) on the BD MAX System. With the new test status, the BD MAX GBS Assay will be available as a cost-effective molecular test for a wider range of laboratories performing GBS screening.

FDA Clears New Test System to Detect TORCH Infections

ZEUS Scientific has announced clearance of its AtheNA Multi-Lyte ToRCH IgG Plus Test System. This new test system is designed for the qualitative detection of specific human IgG class antibodies to Toxoplasma gondii, rubella, cytomegalovirus (CMV), and HSV 1 and 2 (type specific) in human sera (TORCH). According to the company, the assay’s results are meant to be used as an aid in assessing the serological status of individuals, including pregnant women. Serological testing for infection by TORCH organisms in fetuses and newborns can aid in identifying individuals who are at significant risk of adverse outcomes.

Arrayit Seeking PMA for Ovarian Cancer Test

Arrayit, a microarray firm, announced that it will be seeking pre-market approval from FDA for its OvaDx ovarian cancer test. According to the firm, the test is based on Arrayit’s proprietary microarray platform that detects close to 100 protein biomarkers in serum. The company claims that the OvaDx test can identify ovarian cancer 5 years before there are any signs or symptoms.

FDA Clears Radiometer’s New ABL90 FLEX POC Analyzer

Radiometer has received FDA clearance for its ABL90 FLEX analyzer. The new cassette-based analyzer is the latest addition to the company’s blood gas line, offering speed and high-throughput in a compact instrument. The ABL90 FLEX analyzer delivers results on 16 parameters in 35 seconds from 65 µL of whole blood.

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