Vela Diagnostics Gets FDA Approval for HIV-1 NGS Assay

Vela Diagnostics Gets FDA Approval for HIV-1 NGS Assay
HIV-1. Transmission electron micrograph from the CDC.

Vela Diagnostics has received FDA authorization to market its in vitro diagnostic test for detection of HIV-1 genomic drug resistance mutations (DRMs). The Sentosa SQ HIV-1 Genotyping Assay uses the plasma of patients infected with human immunodeficiency virus-1 (HIV-1)to detect HIV-1 Group M DRMs in the protease, reverse transcriptase, and integrase regions of the pol gene, in a single test. It is the first and only HIV-1 genotyping NGS assay currently available on the market to receive FDA marketing authorization.

“The granting of the De Novo designation of our NGS assay by the U.S. FDA is a major milestone in HIV diagnostics. Vela strives to bring relevant products to clinicians to help patients around the world. With the Sentosa SQ HIV-1 Genotyping Assay, laboratories will now have a sample-to-report solution to aid in monitoring and treating HIV-1 infection,” said Sam Dajani, acting CEO & Chairman of the Vela Board.

There are two main types of HIV virus—HIV-1 and HIV-2. Both can lead to AIDS. However, they’re very different. HIV-1 is the most common type, while HIV-2 occurs in a much smaller number of people, mostly in West Africa. HIV-1 and HIV-2 are genetically different and each has multiple groups. Those groups branch out even further into subtypes, or strains. HIV-1 has four groups — one large one and three much smaller ones.  Nearly 90% of all HIV-1 cases stem from the largest HIV-1 group, which is M.

The Vela Diagnostics NGS platform uses semi-conductor based sequencing technologies to translate chemical signals into meaningful information.  Ideal for sequencing targeted regions, the integrated Next-Generation Sequencing (NGS) solution from Vela Diagnostics detects single nucleotide variants as well as insertions and deletions. The automated solution reduces sample-to-sample variability, minimizes risk of rerun due to user error/inconsistency and helps produce more accurate results. Parallel preparation and subsequent analysis of up to 16 sample barcodes are possible.

The Sentosa SQ HIV-1 Genotyping Assay is validated on the Sentosa® NGS workflow that enables automated RNA extraction, PCR setup, library construction, template preparation, sequencing, data analysis, and automated reporting. The workflow also offers clear sample traceability, with seamless LIS integration and connectivity.

Using a standalone version of the curated Stanford University HIV Drug Resistance Database to ensure traceability of the DRM interpretation report, the system generates a clinical interpretation report that provides information on drug resistances associated with detected mutations.

Compared to Sanger bi-directional sequencing and other non-automated NGS alternatives, the Sentosa SQ HIV-1 Genotyping Assay is highly sensitive and delivers clinically relevant results with less than two hours combined of hands-on-time, and a two day turnaround.

Resistance of HIV-1 to antiretroviral drugs as a result of DRMs is the most common cause of therapeutic failure. Detection and reporting of DRMs is thus crucial for optimal selection of Highly Active Antiretroviral Therapy (HAART) regimens and can prevent or minimize the development of resistance to antiviral drugs. The World Health Organization (WHO) also recommends monitoring and reporting early warning indicators (EWI) of HIV drug resistance as a key component of public health strategy when scaling up antiretroviral therapy.

The Sentosa SQ HIV-1 Genotyping Assay was released just as Abbott scientists announced they havediscovered the first new strain of HIV-1 to be identified in almost 20 years. “We are obviously aware of the new strain, the first in 17 years, and accordingly have a collaboration to review the new HIV1 strain and will announce developments as they come to fruition,” said Tim Baxter, executive vice president of Vela Diagnostics US.