Genetics & Genomics Regulatory News

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

Legislators Release New Draft Bill Incorporating FDA Ideas for Diagnostics Regulation

The discussion draft includes the regulatory proposals, including precertification, the FDA provided to legislators in a technical assistance document.

SpeeDx Gets CE-IVD Mark for Antibiotic-Resistant Gonorrhea MDx

The firm said that the Resistance GC assay will allow doctors to treat up to 70 percent of infected patients with a single dose of ciprofloxacin.

FDA Issues Draft Guidance to Address Challenges With CDx Oncology-Class Labeling

The guidance addresses cases in which there's enough evidence to conclude that the CDx is suitable for use with a specific group or class of oncology therapies.

New York State Approves OneOme PGx Test

The test covers 27 genes in which variants are known to contribute to the effectiveness or safety of more than 360 medications for 30 conditions.

FDA Recognizes ClinGen Database for Development of Clinical Tests

The endorsement is the agency's first through the Human Variant Database Program, for which it released final guidance earlier this year.

Dec 04, 2018

FDA Proposes More Efficient, Transparent De Novo Clearance Pathway

Dec 04, 2018

Asuragen Myotonic Dystrophy 1 Dx Kit Receives CE Mark

Nov 30, 2018

FDA Clears Meridian Bioscience's Newborn Cytomegalovirus Test

Nov 28, 2018

Invivoscribe CDx Assay Gets Expanded FDA Approval Alongside Astellas AML Drug

Nov 27, 2018

Invivoscribe Submits FLT3 Mutation CDx Assay to FDA

Nov 27, 2018

Loxo's Pan-Cancer Drug Garners FDA Approval for Patients With NTRK Fusions

Nov 26, 2018

FDA Developing New Pathway for Device Clearance

Nov 26, 2018

Group B Strep Test From DiaSorin Molecular Cleared by FDA

Nov 26, 2018

PerkinElmer Vanadis NIPT Receives CE-IVD Mark

Nov 19, 2018

Invivoscribe Submits FLT3 Mutation Assay CDx to Japanese Regulators

Nov 15, 2018

FDA, Industry Willing to Collaborate on Dx Regulation via Legislation Despite Differences

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Nov 13, 2018

Health Canada Approves Two BCR-ABL Tests

Nov 05, 2018

FDA Actions on PGx Testing Confuse Genetic Industry Players

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Nov 01, 2018

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

Oct 31, 2018

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

Oct 25, 2018

Abbott Molecular Flu, Strep Tests Get FDA Clearance

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

Breaking News

The Scan

Blame the Follicles

A genome-wide association study highlights a potential role for hair follicles in acne risk, according to New Scientist.

Missed a Few

Newsday reports that breast cancer genetic testing guidelines for are out of date and may miss individuals.

This Week in Cell

In Cell this week: gene editing-based strategy to screen for immune system regulators, ancient plague patterns, and more.

Yep, Couple of Concerns There

Publication of He Jiankui's work on gene-edited infants would raise ethical concerns for journals, Wired and others report.