FAIRFIELD, NJ, January 7, 2022 / PRNewswire / – Vela Diagnostics has announced that its SentosaÂ® The SQ HIV-1 genotyping test is covered for reimbursement by the Centers for Medicare and Medicaid (CMS) from January 2022.
Based on the CMS 2022 Clinical Diagnostic Laboratory Fee Schedule, healthcare providers using the SentosaÂ® The SQ HIV-1 Genotyping Assay solution with the assigned descriptor for therapeutic diagnostics can expect reimbursement of US $ 725 using the CPT code 0219U for the analysis of HIV * genes.
the SentosaÂ® The SQ HIV-1 Genotyping Assay is a sample-to-outcome solution that uses Next Generation Sequencing (NGS) on the SentosaÂ® NGS Workflow, providing automation for extraction, library and model preparation, and bioinformatic analysis with reference to the Stanford University HIV Drug Resistance Database. The test analyzes three key drug targets (protease, reverse transcriptase, and integrase) in a virus genome in a single pass. Mutations in these regions can confer drug resistance and lead to treatment failure. The analysis of the integrase gene is remarkable – this SentosaÂ® is currently the only FDA-cleared genotyping test with this capability.
Automation could be the key to streamlining genotyping in the clinical setting, which has historically been an arduous and time consuming process. “Our SentosaÂ® The SQ HIV-1 genotyping assay dramatically reduces technician time compared to traditional methods based on Sanger sequencing, requiring less than 2 hours of manipulation between sample and report generation. By combining the effectiveness of NGS techniques and testing three common drug targets in one go, our solution provides essential information about the drug resistance profile of the virus in an efficient and streamlined workflow, âsaid Steve wallace, Executive Vice President.
âThere are approximately 1.1 million people living with HIV in the United States and 25.4 million in the WHO African Region, of which approximately 8 million people living with HIV are either undiagnosed or improperly treated. . In the current COVID-19 pandemic, this seropositive population could serve as a large reservoir for the emergence of SARS-CoV-2 variants, such as the recent Omicron, which could have been incubated in an immunocompromised person, âsaid Sam dajani, Chief Executive Officer and Executive Chairman of the Board of Directors.
âWe are encouraged that CMS is now reimbursing our SentosaÂ® SQ HIV-1 genotyping test. This will allow more laboratories to bridge the gap that may have dissuaded them from switching to newer technology that offers higher sensitivity and possibly better clinical outcomes for HIV patients, âDajani added. .
In addition to receiving FDA De Novo clearance, the test has received approval from the Thai FDA and the Singapore HSA.
* Where applicable, according to CMS reimbursement rules.
About Vela Diagnostics
Vela Diagnostics is a leading provider of IVD solutions, from sample to outcome on an integrated workflow. VELA’s test solutions have the unique ability to leverage a single system for NGS and PCR testing in infectious disease and oncology.
All SentosaÂ® the products listed above are from Vela Diagnostics. For more information visit www.veladx.com.
SOURCE Vela Diagnostics