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Orchid Receives US Approval for Cystic Fibrosis Diagnostic Kit

NEW YORK, Aug 16 – Orchid BioSciences said Thursday it had received approval to provide its cystic fibrosis genetic screening test to certain approved labs in the United States.

The Elucigene CF 29 test screens for 29 common mutations associated with cystic fibrosis and includes the 25 mutations the American College of Medical Genetics recommends for cystic fibrosis testing.

The Elucigene test uses allele specific amplification, a modified version of the polymerase chain reaction, to detect mutations.

For the past decade Europe has been using Elucigene kits and reagents to test for mutations. 

This will be Orchid’s first genetic diagnostic launched in the US. Orchid of Princeton, NJ, recently said that this European subsidiary had registered its Elucigene CF20 kit in France for human in-vitro diagnostic use.

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.