Diagnostics Regulatory News

The latest headlines on diagnostics regulation: FDA, CMS, and international regulatory agencies.

Lucid Diagnostics Gets FDA 510(k) Clearance for Esophagus Cell Collection Device

The firm is also developing a methylated DNA biomarker test — called EsoCheck Dx — for Barrett's esophagus that uses samples collected with EsoCheck.

Liquid Biopsy Assay From MSKCC Approved by New York State

MSK-ACCESS sequences 129 cancer-associated genes selected from the MSK-IMPACT assay and is designed to detect gene alterations in cfDNA specimen.

FDA Clears Quidel Drug Screen, Toxicology Test

The test, cleared for use with Quidel’s Triage MeterPro instrument, uses monoclonal antibodies that are specific for the metabolites of nine drug classes.

Japanese Regulators Approve Invivoscribe Assay as CDx for Daiichi Sankyo AML Drug

The LeukoStrat CDx FLT3 Mutation Assay can now be used in Japan as the CDx for quizartinib for the treatment of FLT3-ITD positive relapsed or refractory AML.

AstraZeneca, Merck's Lynparza, Myriad Genetics' BRCA Test Approved in Japan

The drug is for first-line maintenance therapy after BRCA-mutated advanced ovarian cancer patients respond to platinum chemo and the test will identify those with BRCA mutations.