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Vela Affection announced on 5 Nov 2019, that it has accustomed FDA allotment to bazaar its in vitro diagnostic assay for the apprehension of HIV-1 genomic biologic attrition mutations (DRMs). The Sentosa® SQ HIV-1 Genotyping Appraisal uses the claret of patients adulterated with HIV-1 to ascertain HIV-1 Group M DRMs in the protease, about-face transcriptase, and integrase regions of the pol gene, in a distinct test. It is the aboriginal and alone HIV-1 genotyping NGS appraisal currently accessible on the bazaar to accept business allotment from the FDA.
“The acceding of the De Novo appellation of our NGS appraisal by the U.S. FDA is a above anniversary in HIV diagnostics. VELA strives to accompany accordant articles to clinicians to advice patients about the world. With the Sentosa® SQ HIV-1 Genotyping Assay, laboratories will now accept a sample-to-report band-aid to aid in ecology and alleviative HIV-1 infection,” said Sam Dajani, acting CEO & Chairman of the Board.
The Sentosa® SQ HIV-1 Genotyping Appraisal is accurate on the Sentosa® NGS workflow that enables automatic RNA extraction, PCR setup, library construction, arrangement preparation, sequencing, abstracts analysis, and automatic reporting. The workflow additionally offers bright sample traceability, with seamless LIS affiliation and connectivity.
Using a standalone adaptation of the curated Stanford University HIV Biologic Attrition Database to ensure traceability of the DRM estimation report, the arrangement generates a analytic estimation address that provides advice on biologic resistances associated with the detected mutations.
Compared to Sanger bi-directional sequencing and added non-automated NGS alternatives, the Sentosa® SQ HIV-1 Genotyping Appraisal utilizing the Sentosa® NGS workflow is highly acute and delivers clinically accordant after-effects with bargain hands-on time (
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