DiaCarta Expands Board Leadership with Industry Veteran
DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology tests using liquid biopsy, today announced the appointment of Jack Kaye, retired Partner with Deloitte LLP, as an independent board member who will serve as the Chairman of the Company’s Audit Committee.
DiaCarta Enters a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to Develop Cancer Tests based on its Novel XNA Technology
DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology tests using liquid biopsy today announced that the company, under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health, will collaborate on the evaluation and development of DiaCarta’s proprietary xeno-nucleic acid (XNA) molecular clamping technology. NCI and DiaCarta will collaborate on the following projects: (1) the investigation of low frequency mutation events in cancers and rare diseases using DiaCarta’s proprietary xeno-nucleic acid (XNA) molecular clamping technology, and (2) the development of XNA probes for in situ cancer cell detection. The duration of the CRADA will be 2 years from the effective start date.
DiaCarta’s Multivariant COVID-19 Test Accurately Detects the Omicron Variant
DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology tests using liquid biopsy announced today that the company has developed a novel test to detect the newest COVID-19 Omicron variant, based on its proprietary XNA technology.
DiaCarta and the Scientific World Mourns the Passing of CSO, Michael J. Powell, Ph.D.
DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel virology and oncology tests, mourns the passing of Michael “Mike” J. Powell, Ph.D., Chief Scientific Officer of DiaCarta.
DiaCarta Receives CE/IVD for its New COVID 19 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 rest of the world. This new 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 (S. Africa), Gamma (Brazil), Delta (India), Delta Plus (India), Epsilon (California) and the Kappa (India) variants.
Former AstraZeneca Personalized Healthcare Strategy Leader Named Senior Vice President of Companion Diagnostics at DiaCarta
DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology tests using liquid biopsy, today announced the appointment of Hongjun “Harry” Yang, Ph.D., former Executive Personalized Healthcare Strategy Leader at AstraZeneca, as Senior Vice President of Companion Diagnostics (CDx) at DiaCarta.
DiaCarta’s Novel XNA Technology Rapidly Detects Raging New SARS-CoV-2 Variants
DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology tests using liquid biopsy today announced the publication of a study entitled “A Rapid SARS-CoV-2 Variant Detection by Molecular-Clamping Based RT-qPCR” in MedRxiV that demonstrates the enhanced sensitivity and specificity using its proprietary XNA based Molecular Clamping Technology that uses innovative synthetic Xenonucleic acid molecular oligomers (XNA) that hybridize with target wild-type DNA sequences, acting as molecular clamps, to enable the accurate amplification of mutant sequences only, using quantitative real-time polymerase chain reactions (qPCR).
DiaCarta Announces Publication in Nature Scientific Reports Demonstrating cfDNA Biomarker Algorithm Predicts Response and Outcome of Chemotherapy
DiaCarta Inc., a precision molecular diagnostics company with proprietary technologies for the development of novel liquid biopsy oncology tests, announced today the publication of a study in Nature Scientific Reports that demonstrates that DiaCarta’s cfDNA biomarker algorithm could function as a prognostic biomarker and efficacy predictor for non-small cell lung cancer (NSCLC) patients.
FDA Report: DiaCarta COVID-19 Tests Rank Top 3 Among FDA SARS-CoV-2 Reference Panel Tests
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 COVID-19 Test Ranks Top 10 Among All FDA EUA Tests Based on Limit of Detection
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 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.
CIO Bulletin Announces DiaCarta Inc. As One of the 30 Fastest Growing Companies of 2018
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 Inc. Launches Ultra-Sensitive TaqMan-Based qPCR Assays for Cancer Gene Mutation Detection
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 Named to MedTech Outlook’s Top 10 In-Vitro Diagnostic Technology Solution Providers 2018
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 Inc. Appoints Arrow Diagnostics as Exclusive Distributor for ColoScape™ in Italy
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.
DiaCarta Named to CIO Applications’ “Top 25 Life Sciences Technology Vendors 2018”
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.
DiaCarta and MIODx Join Forces to Develop a Diagnostic Test to Predict Patient Responses to Immunotherapy
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.