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Dx Focus: Clinical and Regulatory PCR and Nucleic Acid Testing News: Sep 1, 2010


Abbott this week said it has received approval from the US Food and Drug Administration to market the Abbott RealTime HBV assay for measuring the viral load of hepatitis B in patients.

Abbott said that the assay is based on real-time PCR and is available for laboratories that use Abbott's m2000 automated molecular diagnostic testing system; and is the only FDA-approved test capable of automating HBV viral load testing from sample extraction to final result.

The test quantifies HBV viral load in human plasma or serum from individuals chronically infected with the virus. It detects and measures all known HBV genotypes by targeting an essential, highly conserved segment of the HBV genome. Abbott said that the test offers a broad dynamic range in that it is capable of quantitating low levels (about 10 IU/mL) and high levels (1 billion IU/mL) in a patient's blood.

The RealTime HBV assay is intended for use as an aid in managing patients with chronic HBV infection undergoing anti-viral therapy, and is not to be used as a screen for the virus or as a diagnostic tool for confirming the presence of HBV, Abbott said. The company also noted that use of the assay to determine the clinical stage of HBV infection has not been established.

Abbott initially introduced the RealTime HBV test in Europe and other markets in 2007.

Asuragen this week launched KRAS and BRAF mutational testing services in its CAP-accredited CLIA laboratory.

Asuragen's KRAS and BRAF tests are laboratory-developed, and are intended to be used and interpreted in conjunction with all other available clinical and diagnostic information when evaluating anti-EGFR treatment options for colorectal cancer patients, the company said.

The tests are validated for use with CRC formalin-fixed paraffin-embedded tissue specimens that contain at least 40 percent tumor area; or that can be enriched to that tumor content in the course of a histological specimen review, according to the company's website. The tests have not been validated on other specimen types or other human malignancies. The testing process comprises specimen receipt and accessioning; pathologist review and slide enrichment; DNA extraction; and mutation-specific multiplex PCR amplification and detection.

Asuragen said that it designed the tests in response to newly modified guidelines from the American Society of Clinical Oncology and the National Comprehensive Cancer Network.

Asuragen's KRAS 7 mutation testing service detects the seven clinically relevant KRAS mutations in codons 12 and 13; and the KRAS 12 mutation test configuration expands this to detect an additional five KRAS mutations in codon 13. Asuragen noted that NCCN guidelines state that testing for mutations in BRAF, which are identified in 3 percent to 12 percent of CRC patients, should occur when KRAS testing indicates KRAS wild type.