DiaCarta Secures NCI SBIR Funding to Advance RadTox QuantiDNA™ for In Vitro Monitoring of Radiotherapy Response
Recently, DiaCarta, a U.S.-based biotechnology company, announced that it has been awarded Small Business Innovation Research (SBIR) funding from the National Cancer Institute (NCI). The funding will support the collaborative program between DiaCarta and the University of Florida Health Cancer Center (UFHCC), leveraging the company’s RadTox QuantiDNA precision testing platform.TMTranslate into cutting-edge testing technologies and products capable of monitoring radiotherapy response in cancer patients. The company currently plans to use the obtained funds for clinical trials of cfDNA (cell-free DNA fragments in blood) testing to monitor patients’ radiotherapy response.
DiaCarta is a world-leading biotechnology company integrating precision diagnostics and precision therapeutics. Headquartered in Silicon Valley, San Francisco, USA, the company operates a CLIA-certified clinical laboratory and manufacturing facilities compliant with ISO 13485 and GMP standards. Its portfolio of diagnostic kits and cancer genetic tests covers precise quantitative detection of oncogenic viruses, early screening for colorectal cancer, next-generation sequencing (NGS) of cancer genomes, quantitative analysis of tumor molecular biomarkers, and a specialized series of assays designed for CAR-T immunotherapy. Additionally, the company possesses a big data management platform for precision medicine, offering world-class services in the collection, management, analysis, and mining of genomic big data. Currently, DiaCarta’s sales network spans China, Southeast Asia, Europe, the Americas, Australia, the Middle East, Africa, and other regions. The company has also established subsidiaries and third-party clinical testing centers in Shanghai and Nanjing, China.
DiaCarta boasts a world-class professional team, including three long-term advisors who are Nobel Laureates in Physiology or Medicine. Leveraging its extensive industry experience in clinical laboratory medicine, molecular diagnostics, and molecular biology, DiaCarta has established three precision testing technology platforms in the field of molecular diagnostic reagents. The company holds more than 80 patented technologies and, utilizing its proprietary technology platforms, has developed a series of highly sensitive and specific commercial molecular diagnostic products. DiaCarta is particularly recognized for leading global development in the in vitro diagnostics (IVD) sector with the high accuracy of its blood-based liquid biopsy technology.
Radiotherapy rarely carries the risks associated with surgery and is itself painless. However, because radiation affects normal tissues within the treatment field, it can cause side effects.
The most common side effects include rash in the treatment area, fatigue, and others. The exact cause of fatigue induced by radiation therapy remains unclear. It may be attributed to leukopenia, impacts on the human immune system, or other conditions such as anemia and malnutrition.
Typically, normal cells damaged during radiation therapy can repair themselves automatically after treatment; therefore, these side effects occur only during the course of therapy. However, some radiation-induced damage is long-term, resulting from injury to different types of normal cells. Such injuries, termed late radiation reactions, are irreversible.
RadTox QuantiDNATMIt is one of the company’s three precise detection technology platforms. This technology enables direct detection and quantification of nucleic acids in body fluids without the need for DNA or RNA purification. With funding support from the NCI, DiaCarta will leverage its proprietary QuantiDNATMThis technology directly detects circulating cell-free DNA (cfDNA) in patient plasma to monitor radiation response and the extent of systemic injury during radiotherapy. Currently, there are no reliable and effective clinical methods available for monitoring side effects in patients undergoing radiotherapy.
DiaCarta will leverage blood specimens from prostate cancer patients undergoing radiotherapy at the UF Health Cancer Center and the UF Health Proton Therapy Institute to fully validate its RadTox QuantiDNA assay.TMLaboratory-developed test (LDT) products are designed to meet the requirements of CLIA testing services, thereby preparing for a wide range of clinical service offerings. Meanwhile, the company stated that it will also gradually seek regulatory approval for global distribution of these products.
“We are refining a diagnostic test with significant medical implications to meet the healthcare needs of patients undergoing radiation therapy for cancer. This method enables direct monitoring of the severity of side effects and tumor response within days of initiating radiotherapy, thereby addressing an unmet need in the field of cancer radiation oncology,” said Dr. Paul Okunieff, Chair of the UF Health Cancer Center and Director of the UF Health Proton Therapy Institute.
The support and collaboration from the NCI affirm this technological product, while also marking DiaCarta’s technology as being at the forefront of the field. This positions the company to take an early lead in the development of quantitative liquid biopsy technologies, facilitating personalized radiotherapy for cancer patients. DiaCarta will further enhance the quality and safety of personalized cancer treatment. This is also exciting news for the UC Davis Comprehensive Cancer Center and Dr. Okunieff’s laboratory.
“This will be the first in vitro diagnostic (IVD) test product, and the first cfDNA assay supported by the National Cancer Institute (NCI) for real-time monitoring of radiotherapy responses in both tumor and normal tissues, marking a breakthrough in the field of radiation oncology. It represents a significant milestone in the monitoring of patient responses to radiotherapy,” said Dr. Zhang Aiguo, CEO of DiaCarta. Despite decades of innovation and rapid advancement in cancer care technologies, 70% of cancer patients still require radiotherapy, and challenges remain regarding its safety and efficacy. Dr. Zhang added, “Our QuantiDNA™ assay has the potential to overcome these challenges.”
DiaCarta also aims to establish a partnership with UFHCC, one of the largest cancer centers in the United States, to validate the innovativeness and efficacy of this testing technology. Dr. Zhang Aiguo emphasized, “DiaCarta is committed to the field of precision medicine and has achieved significant success in biomarker discovery and the development of breakthrough technologies. The company also looks forward to this technology enhancing radiotherapy outcomes and safeguarding patients’ quality of life.”