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The Sofia 2 Lyme FIA uses a bidirectional test strip format. One side of the test strip detects IgM antibodies to B. burgdorferi; the other side of the strip detects IgG antibodies to B. burgdorferi.

It is the fourth FDA-cleared, CLIA-waived Sofia test for use on the Sofia 2 system. The others are the Influenza A+B FIA, RSV FIA, and Strep A+ FIA. Quidel also markets the moderately complex Sofia Lyme FIA in the U.S., as well as Sofia Legionella FIA and Sofia S. pneumoniae FIA in Europe.

Natera signs agreement with Bristol-Myers Squibb

Natera announced an agreement with Bristol-Myers Squibb for use of Natera’s Signatera custom circulating tumor DNA assay in a prospective phase two adjuvant non-small cell lung cancer clinical trial.

The study will use the Signatera ctDNA assay to select patients who have minimal residual disease after surgical resection to receive adjuvant standard of care with or without Opdivo (nivolumab). The first patient is expected to enroll in 2019 once Natera completes validation of its Signatera ctDNA assay.

This study is the first prospective clinical trial using Natera’s Signatera ctDNA assay in adjuvant NSCLC, the company said in a statement. Charles Swanton, MD, PhD, senior group leader of the translational cancer therapeutics laboratory, Francis Crick Institute, London, will lead the study.

Draft LCD for Veracyte’s Envisia Genomic Classifier

Veracyte received a draft Medicare local coverage determination for its Envisia Genomic Classifier through the MolDx program. WPS Health Solutions posted a draft policy Aug. 30, and the three other MACs (CGS, Noridian Health Solutions, and Palmetto GBA) that participate in the Palmetto GBA-administered MolDx program were expected to issue similar LCDs, according to Veracyte.

The Envisia classifier is the first test to achieve this coverage for use in diagnosing idiopathic pulmonary fibrosis, Veracyte said in a statement.

The draft policy was open to a 45-day comment period.