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DiaCarta Receives NCI Contract for a Circulating Free DNA (cfDNA) Test to Monitor Radiation Response in Cancer Patients

by | Oct 26, 2016 | Press Releases

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, which has clinical laboratory sites located in the San Francisco Bay area and Nanjing, China, has developed and commercialized a suite of highly sensitive and specific technologies and products for the detection and quantitation of nucleic acids directly from bodily fluids without DNA purification. With support from the NCI, DiaCarta will employ its QuantiDNATM to monitor circulating free DNA (cfDNA), a patented DNA biomarker, directly from patient plasma during radiation therapy. Currently, there exists no reliable methodology for determining radiation response during radiotherapy. Utilizing blood specimens from patients undergoing radiotherapy for prostate cancer at the UF Davis Cancer Center and the UF Health Proton Therapy Institute, DiaCarta will fully validate their current RadTox QuantiDNATM product as a laboratory developed test (LDT) and pursue regulatory approval for global distribution.

“This will be a breakthrough ‘first-in-class’ IVD test in the field of radiation therapy and the first cfDNA test to be supported by the NCI for real-time detection of tumor and normal tissue responses to radiation. It is a significant milestone in the field of patient monitoring of radiation therapy response,” said Aiguo Zhang, PhD, CEO of DiaCarta. “Radiation treatment is required by 70% of cancer patients,” he said. “However, despite decades of advances in cancer care and technology, there remain many fundamental challenges affecting safe and efficacious delivery of radiation treatment. Our QuantiDNATM test has the potential to overcome these challenges.”

“We are fulfilling an unmet medical need in cancer radiation therapy by enabling the direct monitoring of side effect severity and tumor response within days of treatment initiation,” said Paul Okunieff, MD, chair of the Department of Radiation Oncology at the UFHCC. “This NCI-supported contract puts us in a powerful position to begin development of quantitative and personalized ‘liquid biopsies.’ It is a very exciting opportunity for the UF Department of Radiation Oncology and the Okunieff Lab to make a real difference in the quality and safety of care for individual cancer patients.”

“DiaCarta is committed to precision medicine with our strong expertise in biomarker discovery and breakthrough technologies. RadTox QuantiDNATM has the potential to make personalized medicine in radiation oncology a reality. We are very excited to collaborate with the UFHCC, one of the largest cancer centers in the U.S., to validate the novel test and potentially increase the quality and safety of radiation therapy for its patients,” said Dr. Zhang.

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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.

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