In This Issue...
Siemens Gets FDA Nod for Rheumatoid Arthritis Test
The Food and Drug Administration (FDA) has cleared Siemens Healthcare's anti-cyclic citrullinated peptide IgG assay for the early diagnosis of rheumatoid arthritis (RA). Designed for use on Siemens' Immulite 2000/2000 XPi immunoassay systems, this assay allows labs to integrate RA testing on an automated, random-access analyzer. According to the company's press release, the test has a clinical specificity of 97% and enables physicians to determine RA prognosis while ruling out other inflammatory and arthritic conditions.
FDA Approves Melanoma Co-Diagnostic From bioMérieux
bioMérieux received FDA approval for its molecular test THxID TM-BRAF, a companion diagnostic that qualitatively and simultaneously detects BRAF V600E and V600K mutations in late-stage metastatic melanoma tumor samples. This real-time PCR test is designed to help oncologists identify patients with BRAF-mutant unresectable or metastatic melanoma who might benefit the most from treatment with the drugs Tafinlar or Mekinist. bioMérieux developed this assay as part of a collaboration with GlaxoSmithKline initiated in 2010.
Roche Granted FDA Approval for NSCLC Co-Diagnostic
FDA approved Roche's cobas EGFR Mutation Test in conjunction with the non-small cell lung cancer (NSCLC) drug Tarceva. Tarceva is the first personalized medicine approved for the initial treatment of metastatic NSCLC patients whose tumors contain specific epidermal growth factor receptor (EGFR)-activating mutations. By determining which patients have these mutations, the cobas EGFR Mutation Test will help guide therapy with Tarceva.
FDA Clears Pleural Fluid pH Test From Siemens
Siemens has obtained FDA clearance to provide pleural fluid pH testing on its RAPIDPoint 500 Blood Gas System for management of patients with parapneumonic effusions. Using a single, whole-blood sample, the RAPIDPoint 500 can deliver laboratory-quality results in approximately 1 minute, and its measurement cartridges last up to 28 days. According to the company's press release, it increases accuracy to conduct pleural fluid pH readings with a Siemens blood gas analyzer compared to a pH meter or indicator stick.
DiaSorin Hypertension Assay Cleared by FDA
DiaSorin received FDA clearance for its Liaison Aldosterone immunoassay for the diagnosis of hypertension. The assay quantitatively determines aldosterone in human serum, EDTA plasma, and urine samples. Along with the new aldosterone assay, DiaSorin's Liaison analyzer menu includes the Direct Renin assay, allowing labs to analyze hypertension on one platform.
FDA Clears First HbA1c Test for Diabetes Diagnosis
FDA granted clearance to Roche for its laboratory-based test, the cobas Integra 800 Tina-quant HbA1cDx assay. This is the first HbA1c test that FDA has deemed accurate enough for both diagnosing diabetes and monitoring patients' blood glucose control, the latter being the standard use for HbA1c tests. Researchers found less than a 6% difference in accuracy between test results from the Tina-quant HbA1cDx assay and the standard reference for hemoglobin analysis, according to the company's press release. However, Roche states that this assay should not be used to: diagnose diabetes during pregnancy; monitor diabetes in patients with hemoglobinopathy, hereditary spherocytosis, malignancies, or severe chronic, hepatic and renal disease; nor to diagnose or monitor diabetes in patients with the hemoglobin variant hemoglobin F.