In This Issue...

Cepheid Receives FDA Nod for Rapid Tuberculosis Test

The U.S. Food and Drug Administration (FDA) has cleared Cepheid's Xpert MTB/RIF test for the identification of tuberculosis (TB)-positive patients. Designed for use on Cepheid's GeneXpert Systems, this new assay performs rapid molecular detection of Mycobacterium tuberculosis complex (MTB-complex) DNA, reducing the wait for results from 6 weeks to 2 hours. When MTB-complex DNA is detected in a specimen, Xpert MTB/RIF can also detect rifampin-resistance associated with mutations of the rpoB gene. Rifampin is an important TB drug, and strains that show resistance to it are often multidrug-resistant as well, requiring more intensive drug therapy.

Use of HPV Assay on Hologic's Panther System Granted FDA Approval

FDA approved Hologic, Inc.'s Aptima HPV assay for use on the company's fully automated Panther system. Using a Hologic ThinPrep liquid cytology specimen, this mRNA-based assay detects 14 high-risk strains of human papillomavirus (HPV) associated with cervical cancer and precancerous lesions by nucleic acid amplification. Its addition to the Panther menu expands the ability of low- to high-volume laboratories to run multiple tests from a single specimen on this platform.

FDA Approves Qiagen's Lung Cancer Co-Diagnostic

Qiagen received FDA approval for its therascreen EGFR test as a companion diagnostic for Gilotrif, a new therapeutic from Boehringer Ingelheim that targets metastatic non-small cell lung cancer (NSCLC) tumors with the most common EGFR gene mutations. These include EGFR exon 19 deletions and exon 21 L858R substitution mutations. The test also features the ability to detect EGFR mutations in separate tubes. Developed through a collaboration with Boehringer Ingelheim, this is the third assay approved or cleared for use on the Rotor-Gene Q MDx, a real-time PCR platform in the QIAsymphony line.

Luminex Gets FDA Clearance for Updated Drug Metabolism Assay

FDA granted Luminex Corporation clearance for a new version of the xTAG CYP2D6 Kit that determines a patient's cytochrome P450 2D6 (CYP2D6) genotype by analyzing DNA extracted from blood. According to the company, this test can help guide treatment decisions involving the more than 25% of drugs metabolized by CYP2D6. Designed to run on the Luminex 100/200 instrument, the new version of this assay optimizes performance on the *17 allele and features an updated software algorithm that detects all 17 genotypes for which the assay is cleared.

Randox Immunoassay Controls Cleared by FDA

FDA cleared Randox's Acusera Immunoassay Speciality 1 control, a quality control (QC) that contains the following nine complex immunoassays: I-25-(OH)2–vitamin D, 25-OH-vitamin D, C peptide, insulin, insulin like growth factor 1, procalcitonin, parathyroid hormone, anti-thyroglobulin, and anti-thyroperoxidase. This control works with most immunoassay analyzers, and according to the company's press release, it is the only multi-analyte immunoassay QC on the market that contains clinically relevant levels of vitamin D. To enhance its stability, the control is lyophilized, and when reconstituted it remains stable for up to 5 days at 2–8°C and 4 weeks at -20°C. It is manufactured independently using 100% human serum to minimize antibody cross reactivity and can be used with Acusera 24.7.