Genetics & Genomics Regulatory News

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

Health Canada Approves Two BCR-ABL Tests

The tests from Asuragen and MolecularMD are designed for use in chronic myeloid leukemia patients, including those receiving tyrosine kinase inhibitor therapy.

FDA Actions on PGx Testing Confuse Genetic Industry Players

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The genetic testing community is having a tough time deciphering FDA's intentions based on its authorization of 23andMe’s PGx test and a recent safety alert.

FDA Tells Patients, Docs to Take Caution When Using Unapproved PGx Tests to Make Treatment Decisions

The agency informed the public that most PGx tests haven’t been reviewed by the agency, and they should refer to information in FDA approved product labels when using such tests.

23andMe Gains FDA Market Authorization to Sell PGx Test Reports Directly to Consumers

The market authorization came with a number of caveats and special requirements that 23andMe must follow when selling its PGx tests to consumers.

Abbott Molecular Flu, Strep Tests Get FDA Clearance

Abbott said that the next-generation molecular POC assays have also been CLIA waived for use on the Abbott ID NOW instrument, formerly called Alere i.

Oct 24, 2018

Agena Biosciences MassArray System Cleared by China FDA

Oct 22, 2018

Zeesan Biotech Wins China FDA Approval for HPV Genotyping Assay

Oct 22, 2018

MRC Holland Gets CE-IVD Mark for Spinal Muscular Atrophy Assay

Oct 18, 2018

DiaSorin Receives CE Mark for Simplexa Group B Strep Assay

Oct 18, 2018

Co-Diagnostics Receives CE-IVD Marking for Zika Test

Oct 17, 2018

Thermo Fisher Scientific Gets CE-IVD Mark for NGS Cancer Test

Oct 16, 2018

FDA Approves Myriad Genetics BRCA CDx With Pfizer's Metastatic Breast Cancer Drug

Oct 16, 2018

BD Obtains CE Mark for Molecular TB, MDR-TB Assay

Oct 15, 2018

FDA Guidances Elucidate Agency's Regulatory Thinking on Precision Oncology Drug Development

Oct 12, 2018

AmoyDx Lung Cancer CDx Approved in South Korea

Oct 11, 2018

FDA Approves Progenika MDx Assay for Blood Compatibility

Oct 08, 2018

Bioneer Obtains CE-IVD Marking for HIV-1 Kit

Oct 02, 2018

GenMark Submits ePlex BCID Gram-Negative, Fungal Pathogen Panels for FDA Clearance

Oct 02, 2018

DiaSorin Receives CE Mark for Varicella-Zoster Virus Assay

Oct 01, 2018

Applied Biocode MDx System, GI Pathogen Panel Get FDA 510(k) Clearance

Oct 01, 2018

FDA Authorizes Adaptive Biotechnologies NGS Test for Minimal Residual Disease

Sep 28, 2018

FDA Approves Expanded Use of Qiagen EGFR CDx in Lung Cancer

Sep 20, 2018

Noridian Issues Draft LCD for GenomeDx Prostate Biopsy Genomic Classifier

Sep 19, 2018

Cepheid Fingerstick HCV Test Receives CE-IVD Clearance

Sep 05, 2018

Asuragen Gets CE Mark for QuantideX NGS Oncology Panel

Breaking News

The Scan

Halt Under Consideration

The United Nations is to consider a ban on field testing gene drives at a meeting being held next week, Technology Review reports.

How's It Going to Go Over?

The Associated Press reports that gene-edited food may soon be for sale.

Meetings on Fetal Research

The US Department of Health and Human Services is beginning a series of meetings on human fetal tissue research, Stat News reports.

This Week in Cell

In Cell this week: epigenetic change linked to glioblastomas, rare and low-frequency variants contributing to multiple sclerosis risk, and more.