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

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Chronic Lymphocytic Leukemia Test Gets Nod

Abbott has received FDA clearance to market its new test to help determine the prognosis of patients with chronic lymphocytic leukemia (CLL). The Vysis CLL FISH Probe Kit works by detecting genetic abnormalities in lymphocytes. It includes five probes intended to detect deletion of the LSI TP53, LSI ATM, and LSI D13S319 probe targets and gain of the D12Z3 sequence in peripheral blood specimens from untreated patients with B-cell CLL.

Clearance for Influenza A/B Assay

IQuum’s assay for detecting and differentiating influenza A and B in roughly 20 minutes has received FDA clearance. The Liat Influenza A/B Assay is an automated sample-to-result multiplex real-time polymerase chain reaction test intended for use in CLIA-certified laboratories.

ROTEM Assays for New Hemostasis Analyzer Cleared

FDA has cleared ROTEM’s hemostasis analyzer for market. The ROTEM analyzer is designed to help clinicians get faster and more complete information about their patients’ coagulation status. The analyzer and five assays, including in-tem, ex-tem, hep-tem, fib-tem, and ap-tem, are intended to guide cardiovascular, trauma, and liver transplant procedures. The ROTEM hemostasis analyzer system also provides in-depth information on all stages of hemostasis.

Companion Dx Test and Drug for Late-Stage Skin Cancer Approved

FDA has approved Roche’s cobas 4800 BRAF V600 Mutation Test for late-stage unresectable melanoma. The polymerase chain reaction-based, companion diagnostic test is intended to help physicians determine if a patient’s melanoma cells have the BRAF V600E mutation. The test was approved along with Zelboraf (vemurafenib), a drug co-developed with Daiichi Sankyo, to treat patients with late-stage melanoma whose tumors have the BRAF V600E mutation.

Approval for Companion Dx Test: Pfizer’s NSCLC Drug

FDA has approved Abbott’s companion diagnostic test designed to detect rearrangements of the anaplastic lymphoma kinase (ALK) gene in non-small-cell lung cancer (NSCLC). The Vysis ALK Break Apart FISH Probe test is designed to identify ALK-positive NSCLC patients for Pfizer's approved NSCLC therapy, Xalkori (crizotinib), an oral first-in-class ALK inhibitor. The test uses fluorescence in situ hybridization technology to detect rearrangements on the ALK gene on the 2p23 chromosome.