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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

US Booster Eligibility Decision

The US CDC director recommends that people at high risk of developing COVID-19 due to their jobs also be eligible for COVID-19 boosters, in addition to those 65 years old and older or with underlying medical conditions.

Arizona Bill Before Judge

The Arizona Daily Star reports that a judge is weighing whether a new Arizona law restricting abortion due to genetic conditions is a ban or a restriction.

Additional Genes

Wales is rolling out new genetic testing service for cancer patients, according to BBC News.

Science Papers Examine State of Human Genomic Research, Single-Cell Protein Quantification

In Science this week: a number of editorials and policy reports discuss advances in human genomic research, and more.