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.

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In Science this week: intellectual property landscape of CRISPR genome editing, and more.

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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. 

Mar
09
Sponsored by
Bio-Rad

This webinar will discuss how next-generation sequencing and digital PCR can be used in a complementary manner for liquid biopsies in order to improve patient care.