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Dx Focus: Cepheid Updates Xpert BCR-ABL Assay; CBLPath Offers NRAS Mutation Test


Cepheid this week released an updated Xpert BCR-ABL Monitor test that incorporates lot-specific standardization using the World Health Organization BCR-ABL standards.

Cepheid is launching the test as a European CE IVD-marked product. The assay runs on Cepheid's GeneXpert system and detects the BCR-ABL mRNA transcript in the peripheral blood of patients with chronic myelogenous leukemia in about two hours.

"The new lot-specific standardization translates to even greater clinical accuracy for physicians as they compare BCR-ABL values over time within the same patient, as well as comparability across geographic locations where testing is being performed," Cepheid CEO John Bishop said in a statement.

CBLPath last week announced the launch of in-house NRAS mutation analysis testing.

The new PCR-based assay is designed to screen for variations in codons 12, 13, and 61 of the NRAS oncogene that may be present in patients with colorectal cancer, melanoma, and thyroid cancer, Rye Brook, NY-based CBLPath said.

The test may enable oncologists to make more accurate diagnoses and select the most appropriate treatments for patients with these cancers, the company said.