FAIRFIELD, N.J., Jan. 7, 2022
FAIRFIELD, N.J., Jan. 7, 2022 /PRNewswire/ -- Vela Diagnostics announced that its Sentosa® SQ HIV-1 Genotyping Assay is covered for reimbursement from The Centers for Medicare and Medicaid (CMS) starting January 2022.
Based on the 2022 Clinical Diagnostic Laboratory Fee Schedule by CMS, healthcare providers using the Sentosa® SQ HIV-1 Genotyping Assay solution with the assigned descriptor for therapeutic diagnoses can expect a reimbursement of US$725 using CPT code 0219U for HIV gene analysis*.
The Sentosa® SQ HIV-1 Genotyping Assay is a sample-to-result solution that uses Next-Generation Sequencing (NGS) on the Sentosa® NGS Workflow, offering automation for extraction, library and template preparation, and bioinformatics analysis with reference to the Stanford University HIV Drug Resistance Database. The assay analyses three key drug targets (Protease, Reverse Transcriptase and Integrase) within a virus's genome, in a single run. Mutations in these regions can confer drug resistance and lead to treatment failure. Analysis of the Integrase gene is notable – this Sentosa® assay is currently the only FDA-authorized genotyping assay with this capability.
Automation could be the key to streamlining genotyping in clinical settings, which is historically an arduous and time-consuming process. "Our Sentosa® SQ HIV-1 Genotyping Assay drastically reduces technician time compared to traditional methods based on Sanger sequencing, requiring less than 2 hours of hands-on time from sample to report generation. By combining efficiency of NGS techniques and testing three common drug targets in one run, our solution provides critical insights into the virus's drug resistance profile in an efficient and simplified workflow," said Steve Wallace, Executive Vice President.
"There are around 1.1 million people in the US living with HIV, and 25.4 million in the WHO African Region, of which roughly 8 million people with HIV are undiagnosed or poorly treated. In the current COVID-19 pandemic, this HIV-positive population could serve as a large reservoir for the emergence of SARS-CoV-2 variants, like the recent Omicron, that possibly could have been incubated in a person who was immunocompromised," said Sam Dajani, CEO and Executive Chairman of the Board.
"We are the encouraged that CMS now reimburses our Sentosa® SQ HIV-1 Genotyping Assay. This will allow more laboratories to bridge the gap that may have been deterring them from moving onto a newer technology that gives higher sensitivity and possibly better clinical outcomes to HIV patients," added Mr Dajani.
In addition to receiving the FDA De Novo authorization, the assay has received approval from Thailand FDA and Singapore HSA.
*As applicable, per CMS reimbursement rules.
About Vela Diagnostics
Vela Diagnostics is a leading provider for IVD solutions, from sample to result on an integrated workflow. VELA's testing solutions have the unique ability to leverage one system for NGS and PCR testing in infectious disease and oncology.
All Sentosa® products listed above are by Vela Diagnostics. For more information, visit www.veladx.com.