DiaCarta Inc. has filed for EUA with the FDA and has received CE mark for its highly sensitive QuantiVirus™ SARS-CoV-2 Test Kit
Richmond, California, March 24, 2020.
DiaCarta Inc., a precision molecular diagnostic company, announced today that it has filed for Emergency Use Authorization (EUA) with the US FDA for its QuantiVirus™ SARS-CoV-2 test and has validated the COVID-19 diagnostic test in its own CLIA certified lab in Richmond, CA to provide testing services for healthcare providers and patients. DiaCarta recently received Conformitè Europëenne (CE) Mark for its product.
The in vitro diagnostic test based on Real-Time PCR technology is developed for specific detection of SARS-CoV-2 viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs and sputum from patients suspected with coronavirus infection. Three genes of SARS-CoV-2 including N, Orf1ab and E genes are targeted in the real-time PCR (qRT-PCR) assay to ensure high degree of sensitivity and accuracy. The analytical sensitivity is 1-5 copy/uL of SARS-CoV-2 viral RNA for patient sample with a 95% confidence. Clinical validation of the assay showed 96.7% sensitivity and a specificity of 100%, with no cross-reaction to different types of non-SARS-CoV-2 species.
“We are pleased that we can offer our QuantiVirusTM SARS-CoV-2 product to healthcare providers and as a CLIA validated test to our customers” said Dr. Ram Vairavan, Senior Vice President of DiaCarta Inc., “as it will help to fulfil an urgent need, as the coronavirus pandemic continues to shut down daily life across the globe”.
About DiaCarta Inc.,
DiaCarta is a molecular diagnostics company that has developed innovative technologies that transforms patient care by providing effective precision diagnostics using liquid biopsy. Its novel XNA technology provides high level of sensitivity as it binds to the wild-type sequence and enables only the mutant target sequence to get amplified. Using this technology, the company has developed its highly sensitive ColoScape™ Colorectal Cancer Mutation test. Powered by its SuperbDNA™ technology that provides high level of detection as it amplifies the signal and requires no RNA/DNA extraction or amplification, the company has developed its revolutionary RadTox™ test that personalizes radiation therapy, mitigates adverse events and enhances patient care. Based in Richmond, California the company is GMP-compliant and offers CLIA certified laboratory services to its customers. www.diacarta.com
Ram Vairavan PhD
Senior Vice President, DiaCarta Inc.
2600 Hilltop Drive
Richmond, CA 94906
DiaCarta announced that CIO Bulletin has named it among the 30 Fastest Growing Companies of 2018. The positioning is based on DiaCarta’s revenue growth, financial status, openness to innovation, global collaboration and partnership, flagship products launching, regulatory progress and ability to forecast future business and technology trends.
DiaCarta announced that it is launching a new suite of CE-IVD marked highly sensitive hydrolysis probe (TaqMan-qPCR) based QClamp® assays for detection of common cancer mutations in genes, such as KRAS, NRAS, BRAF, EGFR, PIK3CA and JAK2, using tissue biopsy (FFPE) and liquid biopsy (cfDNA) samples.
DiaCarta, Inc., Awarded $2 Million NCI Contract to Pursue Regulatory Approval of Innovative Cancer Radiation Response Blood Test
DIACARTA, Inc. announced today that it has received a $2 million National Cancer Institute (NCI) Small Business Innovation Research (SBIR) contract to continue development of its RadTox™ cfDNA radiation therapy toxicity monitoring test kit for cancer patients.
DiaCarta has been recognized as one of the Top 10 In-Vitro Diagnostic Technology Solution Providers 2018 by Med Tech Outlook Magazine. The positioning is based on an evaluation of DiaCarta’s specialty in genomic testing for biomarkers, personalized diagnostics and clinical sample testing service provided in their CLIA-certified lab.
DiaCarta today announced that it has signed a distribution agreement with Arrow Diagnostics. Under the agreement, Arrow Diagnostics becomes sole distributor of ColoScape™ a multigene biomarker TaqMan qPCR in vitro diagnostic (CE-IVD) test in Italy, San Marino & Vatican City.