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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