Dx Focus: Quidel Gets FDA OK for HSV 1 and 2 Assay | GenomeWeb

Quidel said last week that it has received 510(k) clearance from the US Food and Drug Administration for its AmpliVue HSV 1+2 assay for the differentiation of herpes simplex viruses 1 and 2.

AmpliVue HSV 1+2 uses helicase-dependent amplification technology, an isothermal amplification method, and as such is easy to use, handheld, and disposable, and does not require expensive thermal cycling equipment, Quidel said.

The assay also requires no upfront extraction of DNA, and generates a result in approximately one hour.

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.

In Science this week: metagenomic-based technique for determining protein structure, and more.

An academic laments the rise of narcissism in the sciences, the Guardian reports.

Outgoing FDA commissioner Robert Califf writes in an editorial that the agency can help boost innovation.

The Trump transition team has asked NIH Director Francis Collins to remain at his post, though it's unclear for how long that will be.

Mar
02
Sponsored by
VelaDx

This online seminar will highlight recent advances in the use of next-generation sequencing to detect drug-resistant mutations in patients with HIV or HCV.