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Genetics & Genomics Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

The clearances pave the way to clinical applications for three of MGI's instruments but the BGI subsidiary faces legal challenges from Illumina in Europe and the US.

The group wants the agency to allow labs to discuss gene-drug relationships with "adequate evidence" in test reports and hold a public meeting.

The AlloSeq cfDNA kit is used to quantify the level of donor-derived cell-free DNA in transplant recipients in order to measure graft health.

The firm said its panel, which runs on its MDx-3000 system, tests nasopharyngeal swabs for the most common viruses and bacteria.

Despite the availability of more precision therapies and complex biomarker tests, systemic gaps and lack of physician education continued to hinder access.

Bloomberg Law writes that the Genetic Information Nondiscrimination Act may work better as a privacy, rather than anti-discrimination, law.

TechCrunch reports that Linda Avey has a new personal genomics startup that's focusing on India.

A new report finds that though the US has increased its activity in science and engineering, its global share of that activity has fallen in some areas, according to Inside Higher Ed.

In Nature this week: genomic analysis of rapeseed, universal target enrichment method for metagenomic sequencing, and more.