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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.

The Scan

Enzyme Involved in Lipid Metabolism Linked to Mutational Signatures

In Nature Genetics, a Wellcome Sanger Institute-led team found that APOBEC1 may contribute to the development of the SBS2 and SBS13 mutational signatures in the small intestine.

Family Genetic Risk Score Linked to Diagnostic Trajectory in Psychiatric Disorders

Researchers in JAMA Psychiatry find ties between high or low family genetic risk scores and diagnostic stability or change in four major psychiatric disorders over time.

Study Questions Existence of Fetal Microbiome

A study appearing in Nature this week suggests that the reported fetal microbiome might be the result of sample contamination.

Fruit Fly Study Explores Gut Microbiome Effects on Circadian Rhythm

With gut microbiome and gene expression experiments, researchers in PNAS see signs that the microbiome contributes to circadian rhythm synchronicity and stability in fruit flies.