Close Menu
A recently released guidance to industry and US Food and Drug Administration staff, called “Pharmacogenetic Tests and Genetic Tests for Heritable Markers,” is not explicit enough in outlining when diagnostic companies will need to apply for premarket approval and when a 510(k) clearance will be sufficient, according to a lawyer representing the interests of diagnostic companies, patient groups, and investors.
 

Get the full story with
GenomeWeb Premium

Only $95 for the
first 90 days*

GenomeWeb Premium gives you:
✔ Full site access
✔ Interest-based email alerts
✔ Access to archives

Never miss another important industry story.

Try GenomeWeb Premium now.

You may already have institutional access!

Check if I qualify.

Already a GenomeWeb or 360Dx Premium member?
Login Now.

*Before your trial expires, we’ll put together a custom quote with your long-term premium options.

Not ready for premium?

Register for Free Content
You can still register for access to our free content.

A new Trump executive order about "free inquiry" on college campuses may threaten $35 billion-worth of federal research funding, reports Ars Technica.

As we enter conference season, Nature News asks why graduate students and postdocs are sometimes forced to choose between paying the rent and paying to attend important meetings.

A new analysis says that a 2018 study claiming to show biparental mtDNA inheritance has several flaws.

In PNAS this week: a genome sequence analysis of Crucihimalaya himalaica, multicellularity and fruiting body development in mushroom-forming fungi, and more.

Mar
28
Sponsored by
Qiagen

The Human Gene Mutation Database (HGMD) is a manually curated, comprehensive collection of disease-causing, germline mutations. Since 1996, a team of experts has manually catalogued over a quarter of a million mutations for the database.  

Apr
11
Sponsored by
Bionano Genomics

This webinar will review a recent study that applied whole-genome sequencing and optical genome mapping to identify a large number of previously undetected somatic structural variants in leukemia samples.

Apr
30
Sponsored by
Lexogen

This webinar will discuss novel long-read transcript sequencing (LRTseq) methods for transcriptome annotation that could increase the efficiency and accuracy of future sequencing projects.

May
08
Sponsored by
Sysmex Inostics

This webinar will present recent evidence that demonstrates how incorporating circulating tumor DNA (ctDNA) assessments into real-world patient management can influence patient care decisions, alter radiographic interpretations, and impact clinical outcomes.