Molecular Diagnostics
News on lab-developed tests and emerging diagnostic technologies.
Senators Reintroduce Bill to Establish Medicare Coverage Pathway for MCED Tests
The bill would allow Medicare to cover MCED tests following approval by FDA and ensure their use would not impact coverage of traditional screenings.
The assay detects HPV 16 and HPV 18 DNA within 45 minutes and is intended to be used in low-resource settings.
Bioinformatics Startup Geneyx Builds Business on Whole-Genome, Long-Read Sequencing Analysis
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A recent data-integration partnership with Oxford Nanopore mirrors one that Israel-based Geneyx already has with PacBio in pursuit of higher diagnostic yields.
Exact Sciences Releases Next-Gen Cologuard Data, Inks New Partnerships
The firm said the new version of its colon cancer screening test improved upon its predecessor across a variety of metrics, including both sensitivity and specificity.
FDA Launches Pilot Program to Determine Performance Criteria for Lab-Developed CDx Tests
Through the voluntary program, the agency will ask drug manufacturers for performance information for the tests used to enroll patients in pharmaceutical clinical trials.