DiaCarta’s COVID-19 Test Ranks Top 10 Among All FDA EUA Tests Based on Limit of Detection
Richmond, California, September 2, 2020.
Based on evaluation of all the FDA EUA approved kits before July 27, 2020, DiaCarta’s QuantiVirusTM SARS-CoV-2 Multiplex Test ranks among the top 10 kits in terms of low limit of detection (LoD). DiaCarta is the top 6 company, after Perkin Elmer, Roche, Quest, RTA and BD Biosciences. The QuantiVirusTM SARS-CoV-2 Test, another RT-qPCR-based DiaCarta kit granted with FDA EUA, is top 20 on the list. The evaluation was conducted by MacKay et al. in Nature Biotechnology published on August 20.
Why is low LoD a big deal? According to Arnaout R et al., for every 10-fold increase in LoD, there is a 13% increase in false-negativity. This means tests with higher LoD significantly lower the test sensitivity, although clinical sensitivity and specificity are both over 95% for all 157 tests on the list. Surprisingly, the LoD for these tests spans 5 orders of magnitude from 0.009 to more than 100 copies per mL of sample.
“We are proud to have two viral RNA tests approved by the FDA EUA and CE-marked, both of which are highly sensitive,” Said Dr. Ramanathan Vairavan, Senior Vice President, Commercial Operations at DiaCarta, Inc. “These tests are critical for COVID-19 infection screening as we reopen the economy.”
In addition, DiaCarta has also developed the QuantiVirusTM Anti-SARS-CoV-2 IgG test, which is also filed with FDA and is CE-marked. This sensitive antibody test, once approved by FDA EUA, will add great value identifying potential blood donors for COVID-19 plasma therapy authorized by FDA EUA on August 23, although the risk reduction from the therapy may be relative rather than absolute, according to Dr. Steven Hahn, the FDA commissioner.
To help speed up COVID-19 screening, DiaCarta has validated these tests at our own CLIA lab. With three types of sample collection kits available (nasal, oral, and saliva), DiaCarta offers seamless COVID-19 testing services for healthcare providers, public health departments, businesses, and schools.
DiaCarta is a molecular diagnostics company that has developed innovative technologies to transform patient care. Its novel XNA technology provides ultra-sensitivity for ColoScape™ Colorectal Cancer Test. Powered by SuperbDNA™ technology, the company has developed revolutionary RadTox™ test that personalizes radiation therapy to mitigate adverse events. Based in Richmond, California, the company is ISO certified, GMP-compliant and offers CLIA certified laboratory services.
DiaCarta Receives Regulatory COFEPRIS Approval in Mexico & ICMR Approval in India for its FDA EUA Approved QuantiVirus™ SARS-CoV-2 Test
DiaCarta Inc., a precision molecular diagnostics company with a unique, patented XNA technology platform for the development of novel liquid biopsy tests, announced today that its QuantiVirus™ SARS-CoV-2 test has been approved for distribution in Mexico.
DiaCarta SARS-CoV-2 Test Detecting 3 Viral Genes Receives US FDA Emergency Use Authorization & Test Manufacturing Expanded to 500K COVID-19 Tests/Week
DiaCarta Inc, a precision molecular diagnostic company in CA, announced Thursday the US FDA granted Emergency Use Authorization for DiaCarta’s proprietary QuantiVirus™ PCR diagnostic (Dx) test specifically detecting three different genes of SARS-CoV-2, the virus causing the COVID-19 pandemic. DiaCarta recently expanded manufacturing capacity to 500,000 tests per week and is planning to expand to even larger (4x) scale manufacturing to meet the increasing demand for PCR tests to monitor COVID-19.
DiaCarta Inc. has filed for EUA with the FDA and has received CE mark for its highly sensitive QuantiVirus™ SARS-CoV-2 Test Kit
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.
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.