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Dec 13, 2019

New Drug Approvals More Likely With Supporting Human Genetic Evidence

AbbVie researchers validated and extended a previous study to find different types of genetic evidence have varying influences on approval prospects.

Dec 04, 2019

FDA Approves Foundation Medicine CDx for Novartis Breast Cancer Drug Piqray

The FDA approved FoundationOne CDx as a companion diagnostic for alpelisib in combination with fulvestrant to treat certain PIK3CA-mutated breast cancers.

Dec 03, 2019

Illumina, PacBio Dispute UK Regulator's Finding That Merger Would Weaken Competition

Illumina and PacBio wrote that the agency "has failed to establish that Illumina's short-read systems and PacBio's native long-read systems compete."

Dec 02, 2019

Genetron Health Gets China NMPA Approval for Clinical NGS System, Files for IPO

The Genetron Health S5 NGS system is based on the Thermo Fisher Scientific Ion GeneStudio S5 and will be accompanied by Genetron-developed assays.

Nov 27, 2019

UK Regulator Extends Inquiry Into Proposed Illumina-Pacific Biosciences Merger

In a notice posted on its website, the Competition and Markets Authority said it is extending its inquiry, with a new deadline of Feb. 5, 2020.

Nov 21, 2019

Myriad Genetics BRACAnalysis Approved by Japanese Regulators

Doctors can now order the test to identify breast cancer patients with BRCA1/2 mutations who may be eligible for surgery or targeted therapy.

Nov 19, 2019

Despite FDA Clearance for NantHealth Test, Benefits of TMB Biomarker Unclear

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Recent studies question the clinical utility of tumor mutational burden as a biomarker for immuno-oncology response, and the FDA clearance includes no therapeutic indications.

Nov 05, 2019

FDA Authorizes Marketing of Vela Diagnostics NGS-Based HIV-1 Drug Resistance Mutation Test

It is the first time that the agency has authorized for marketing a next-generation sequencing test for HIV-1 resistance, the FDA noted.

Nov 05, 2019

FindGene Noninvasive Prenatal Screening Kit Gets Approval from Chinese Regulators

The company said three clinical centers have validated the test in a prospective clinical trial involving more than 10,000 participants.

Oct 24, 2019

All of Us Program Working on IDE Submission to FDA, Weighing Long-Read Sequencing Techs

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The program will likely only generate sequencing data, not genotyping array data, for returning health-related results to reduce the complexity associated with two platforms.

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The Scan

That Rude Reviewer

ScienceInsider reports that rude and unprofessional paper reviewers are common and can have harmful effects.

New FDA Commish Confirmed

The US Senate has confirmed Stephen Hahn as the next commissioner of the Food and Drug Administration, according to the New York Times.

DNA Screening for Apple Employees

CNBC reports Apple is partnering with Color Genomics to offer its employees free DNA screening for disease.

Science Studies Describe Role for Microbiome-Derived Immunity, Platform to Develop Flavivirus Vaccines

In Science this week: researchers use CRISPR tool to find gut microbiome molecules involved in immunity, and more.

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  1. New Drug Approvals More Likely With Supporting Human Genetic Evidence

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