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FDA Clears EraGen Kit for HSV 1&2 Detection and Typing on bioMérieux Platform

NEW YORK (GenomeWeb News) – EraGen Biosciences today announced the US Food and Drug Administration has cleared its MultiCode-RTx HSV 1&2 kit for use on bioMérieux's NucliSens easyMag extraction system.

As a result, laboratories can now use either Roche's MagNa Pure system or the easyMag extraction system with the kit.

The MultiCode-RTx HSV 1&2 test is PCR-based and provides qualitative testing and typing of HSV 1 and 2 in about four hours, EraGen said, adding that the recent clearance of a second extraction system makes the test available to labs without the MagNa Pure system.

The 510(k) clearance is for the detection and typing of herpes simplex virus 1 and 2 in vaginal lesion swab specimens from symptomatic female patients 18 years of age and older as an aid for diagnosing genital herpes infection. The device is not cleared by FDA for use in cerebrospinal fluid or lesions other than vaginal, EraGen, a Luminex company, said.

The Scan

Breast Cancer Risk Related to Pathogenic BRCA1 Mutation May Be Modified by Repeats

Several variable number tandem repeats appear to impact breast cancer risk and age at diagnosis in almost 350 individuals carrying a risky Ashkenazi Jewish BRCA1 founder mutation.

Study Explores Animated Digital Message Approach to Communicate Genetic Test Results to Family Members

In the Journal of Genetic Counseling, the approach showed promise in participants presented with a hypothetical scenario related to a familial hereditary breast and ovarian cancer syndrome diagnosis.

Computational Tool Predicts Mammalian Messenger RNA Degradation Rates

A tool called Saluki, trained with mouse and human messenger RNA data, appears to improve mRNA half-life predictions by taking RNA and genetic features into account, a Genome Biology paper reports.

UK Pilot Study Suggests Digital Pathway May Expand BRCA Testing in Breast Cancer

A randomized pilot study in the Journal of Medical Genetics points to similar outcomes for breast cancer patients receiving germline BRCA testing through fully digital or partially digital testing pathways.