Press release

According to the recent FDA SARS-CoV-2 Reference Panel Comparative Data released on September 15, among all the FDA EUA tests with returned results, DiaCarta’s QuantiVirusTM SARS-CoV-2 Test and QuantiVirus™ SARS-CoV-2 Multiplex Test both rank within the top 3 for product sensitivity.

DiaCarta’s QuantiVirus™ 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.

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 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., 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.

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.

CIO Applications has chosen DiaCarta as one of the Top 25 Life Sciences Technology Vendors 2018. The positioning is based on an evaluation of DiaCarta’s specialty in personalized diagnostics, translational genomics and clinical sample testing services provided in both US and China.

MIODx and DiaCarta announced today that they have entered into an agreement for the development of a diagnostic test for immunotherapy. The test is based on MIODx’s ClonoMap™ immune sequencing platform, and is designed to predict patient response to immunotherapy, which will be developed and validated at DiaCarta’s CLIA labs in both the San Francisco Bay Area and Nanjing, China.

DiaCarta has announced that it has completed its Series B funding round, realizing a total of $45.0M USD. The second closing was led by Fortune Fountain Capital (FFC) and was also subscribed to by Good Health Capital (GHC).

ColoScape™ offers high sensitivity and accuracy of detection for clinically validated colorectal cancer mutations in DNA extracted from solid tumor, plasma or stool samples.

California-based molecular diagnostics company DiaCarta, Inc., has received a SBIR contract from the National Cancer Institute (NCI). This contract will fund a collaborative program between DiaCarta and University of Florida Health Cancer Center to convert RadTox QuantiDNATM into a cutting-edge test that monitors radiation response in cancer patients.

DiaCarta today announced the introduction of QFusionTM RT-qPCR assay, a new product for the comprehensive, rapid and reliable detection of ALK fusion gene variants. The assay enables users to detect ten EML4-ALK and three KIF5B-ALK fusion gene variants in a single tube of multiplexed reactions with only 50 ng of RNA from FFPE samples in approximately 1.5 hours.

DiaCarta, an innovator in precision molecular diagnostics, today announced that the company has received ISO 13485:2003 certification for the design, manufacture and distribution of its diagnostic and molecular genetic testing kits.

DiaCarta and Pangaea Biotech S.L have signed a long term agreement to launch in the U.S.A and China a non-invasive test to detect genetic material in blood of cancer patients, a technique known as ‘liquid biopsy’.

DiaCarta, an innovative translational genomics and precision molecular diagnostics company, today announced that DiaCarta Clinical Services Laboratory (DCSL) successfully passed the State of California survey under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

DIACARTA INC. (“DIACARTA”) and UNIVERSITY OF POTSDAM (Germany) today announced that the parties have entered into an exclusive license agreement for the development and commercialization of non-invasive early detection of colon cancer from stool samples.