BioHelix Gets FDA Nod for First Point-of-Care MDx Test | GenomeWeb

By Ben Butkus

BioHelix said this week that it has been granted 510(k) clearance from the US Food and Drug Administration for its IsoAmp HSV Assay for detecting herpes simplex virus in genital and oral lesion specimens from symptomatic patients.

The IsoAmp HSV Assay is BioHelix's first FDA-cleared molecular diagnostic test, and is based on the company's first-generation disposable handheld device using the company's helicase-dependent amplification technology and lateral flow strip detection scheme.

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?

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

Pacific Biosciences is hosting a competition in which researchers are vying to win free sequencing for an organism with the most interesting genome.

An opinion piece appearing in Newsday likens familial DNA searches to stop-and-frisk policies.

The San people of Africa have drawn up a code of conduct for researchers, according to the Conversation.

In Nature this week: genotypes linked to hip osteoarthritis, and more.