DiaCarta Receives CE/IVD for its New COVID 19 Screening Test that Identifies Delta Plus and New Variants

DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology tests using liquid biopsy today announced that its new QuantiVirus™ SARS-CoV-2 Variant Detection Test received the CE/IVD marking and therefore, can now be commercialized within the EU and the rest of the world. This new multiplex qPCR-based test screens for the SARS-CoV-2 virus and simultaneously identifies and differentiates all the new mutating COVID 19 variants including the Alpha (UK), Beta (South Africa), Gamma (Brazil), Delta (India), Delta Plus (India), Epsilon (California) and the Kappa (India) variants.

"This test can be run on commonly available qPCR cyclers, thereby, bypassing the need to perform expensive and time-consuming Next-Generation Sequencing," said Ramanathan Vairavan, Senior Vice President at DiaCarta.

The delta variant, named as "Variant of Concern" by WHO has rapidly spread to over 98 countries and is responsible today for > 93% of the reported COVID-19 cases in the US with more than 97% being vaccinated people [1].Recent studies show that the Delta variant infected population can carry 1000 times more viral load when compared with the original virus and remains infectious for a longer time (18 days versus 13 days)[2]. Delta-mediated deaths in India increased from 15% to 83% between April 1 to May 15, 2021[3]. Due, to its high transmissibility, fully vaccinated populations are having breakthrough infections. SE Asia has recorded 38,522 deaths due to the Delta variant of COVID-19 in the first two weeks of August 2021, nearly twice as many as North America [4].

"Most commercially available COVID-19 tests cannot identify the Delta variant as it carries distinctive biological markers. To solve this challenge, DiaCarta designed the SARS-CoV-2 Variant Detection Test that gives accurate and rapid results," said Vairavan.

References

https://www.umassmed.edu/news/news-archives/2021/07/delta-variant-spurring-uptick-in-covid-19-cases-largely-in-unvaccinated/

https://www.medrxiv.org/content/10.1101/2021.07.07.21260122v2 

https://www.news-medical.net/news/20210702/What-role-did-the-SARS-CoV-2-delta-variant-play-in-Indiae28099s-devastating-second-wave.aspx

https://reliefweb.int/report/indonesia/covid-19-southeast-asia-battles-world-s-highest-deaths

About DiaCarta Inc. 

DiaCarta is a molecular diagnostics company that has developed innovative technologies that transform patient care by providing effective precision diagnostics using liquid biopsy. Using its XNA technology it has developed a highly-sensitive, early detection Colorectal Cancer test. Further its revolutionary RadTox™ test personalizes radiation therapy, mitigates adverse events, and enhances patient care. Based in Pleasanton, California the company is ISO certified, GMP-compliant and offers CLIA certified laboratory services to its customers. www.diacarta.com   

Source: DiaCarta Inc.