By Turna Ray

It's a given that technology moves faster than regulation, but when it comes to the US Food and Drug Administration's framework for laboratory-developed tests, the pace of progress has been particularly slow.

Four months after the FDA announced its intent to regulate LDTs, the agency has yet to put any meat on the bones of its plan to base forthcoming regulations on the intended use and the risk of a given test, and FDA officials have reiterated that they are keeping all ideas on the table.

Get the full story with
GenomeWeb Premium

Only $95 for the
first 90 days*

A trial upgrade to GenomeWeb Premium gives you full site access, interest-based email alerts, access to archives, and more. Never miss another important industry story.

Try GenomeWeb Premium now.

Already a GenomeWeb Premium member? Login Now.
Or, See if your institution qualifies for premium access.

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

Not ready for premium?

Browse our free articles
You can still register for access to our free content.

In PNAS this week: The sea anemone is sequenced, a team describes a CRISPR/Cas9-based approach to label specific sites in the genome, and more. 

In a short video, CNN introduces viewers to a fecal transplant poop donor and explains how the treatments are made.

Researchers are testing the use of transgenically altered diamondback moths as an alternative to pesticides in controlling the bugs.

Two recent papers published in Science and Nature Medicine describe work that may result in a universal vaccine for the flu.

Sep
17
Sponsored by
Omicia

This online seminar will provide examples of how commercial and hospital-affiliated clinical labs are successfully developing and deploying high-throughput next-generation sequencing-based testing services for genetic diseases. 

Sep
24
Sponsored by
Personalis

This online seminar will outline a targeted enrichment technology to improve next-generation sequencing assays for cancer research and clinical applications. 

Oct
07
Sponsored by
Personal Genome Diagnostics

This webinar will highlight the key considerations and applications of next-generation sequencing for managing non-small cell lung cancer patients using plasma-based approaches. 

Oct
15
Sponsored by
Parabase

This webinar will discuss the benefits of a rapid targeted next-generation sequencing (TNGS) panel, using dried blood spots, for second-tier newborn metabolic and hearing loss screening and its immediate utility for high-risk diagnostic testing in the neonatal intensive care unit.