Press release

DiaCarta Announces Publication in Nature Scientific Reports Demonstrating cfDNA Biomarker Algorithm Predicts Response and Outcome of Chemotherapy

Apr 8, 2021 | Press Releases

Richmond, California, April 8, 2021.

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.1

The paper entitled, “Kinetics of Plasma cfDNA Predicts Clinical Response in Non-Small Cell Lung Cancer Patients”1 evaluated the utility of a plasma cell-free DNA (cfDNA) algorithm of pre-chemotherapy (CT) and first cycle post-CT as a prognostic biomarker and efficacy predictor of CT, in NSCLC patients using DiaCarta’s proprietary QuantiDNA™ cfDNA test. The biomarker provides real-time evaluation of the therapy and allows adjustment of treatment at early stage of the therapy if necessary.

The QuantiDNA™ cfDNA test is used to quantify the total amount of cfDNA directly from a plasma sample while the patient is undergoing cancer therapy. The test is highly accurate because it uses DiaCarta’s highly sensitive SuperbDNA™ technology, an extremely reliable and signal-specific amplification platform that allows quantitative detection of specific nucleic acid sequences directly from the source. Previously, the same test, known as RadTox™ test when used for radiotherapy toxicity measurement, was also used to demonstrate the cfDNA algorithm of the pre- and post-radiotherapy patient samples is a potential biomarker for radiotherapy safety measurement.2

Dr. Steven Eric Finkelstein, MD, DABR, FACRO, Editor-in-Chief, Contemporary Radiation Oncology said that “the RadTox™ test has the potential to fulfill an important unmet medical need in cancer therapy by enabling the direct monitoring of cell death within hours after a cancer treatment; thus, they can predict tumor response, irrespective of tumor type, and in postoperative patients predict side effect severity. This unique approach has the potential to provide a fast, cost-effective quantitation of liquid biopsy circulating DNA in cancer patients before and after therapy, providing patient information for early clinical decision making.”

DiaCarta is initiating a large-scale clinical development program, which will monitor cfDNA levels to determine early treatment outcomes of systemic therapy in all types of stage 4 cancer. In addition, DiaCarta will continue to evaluate cfDNA as a predictive marker for early tissue toxicity from various cancer therapies, to facilitate early chemo and/or radiation therapy dose adjustments. Once extensive clinical validation is completed, DiaCarta will pursue regulatory approval to market the RadTox™ test kit worldwide for multiple cancer indications.

“This pivotal study demonstrates the utility of DiaCarta’s developmental pipeline,” said Ram Vairavan, Ph.D., Senior Vice President of Business Development at DiaCarta, Inc. “This data will be used to guide a large clinical development program. The progression of this project has the potential to become a ‘first-in-class,’ class IVD (in vitro diagnostic) test in the field of cancer therapy. Although this new study was focused on lung cancer, the RadTox™ cfDNA test has also been applied to many other cancer patients including colon, breast, pancreatic cancer, etc. and in the past two years DiaCarta has tested over 100,000 samples globally, suggesting a broader application for this technology.”

About DiaCarta Inc.
DiaCarta is a molecular diagnostics company that has developed innovative technologies that transforms patient care by providing effective precision diagnostics using liquid biopsy. In addition to its FDA EUA approved QuantiVirusTM SARS-CoV-2 Test, DiaCarta offers a range of testing services, from single-gene QClamp® qPCR tests to its OptiSeq™ XNA-NGS panels. The company is well positioned as a leader in the new ‘liquid biopsy’ IVD (in vitro diagnostic) field with high-precision detection of cfDNA. Its novel XNA technology provides high level of sensitivity as it binds to the wild-type sequence and enables only the mutant target sequence to get amplified. Using this technology, the company has developed its highly sensitive ColoScape™ early detection Colorectal Cancer test using blood. Powered by its SuperbDNA™ technology that provides high level of detection as it amplifies the signal and requires no RNA/DNA extraction or amplification, the company has developed its revolutionary RadTox™ test that personalizes radiation therapy, mitigates adverse events and enhances patient care. Based in Richmond, California the company is ISO certified, GMP-compliant and offers CLIA certified laboratory services to its customers.

  1. Kinetics of Plasma cfDNA Predicts Clinical Response in Non-Small Cell Lung Cancer Patients, Nature Scientific Reports 11, Article No: 7633; Pages 12; MS code 85797; Dispatch 8-302021. 
  2. Circulating Cell-Free DNA Correlates with Body Integral Dose and Radiation Modality in Prostate Cancer Int J Part Ther 2020 Sep 15;7(2):21-30. doi: 10.14338/IJPT-20-00033.1. eCollection Fall 2020.

Richard Brand, CFO, DiaCarta 

Olipriya Das, Ph.D.,Russo Partners

SOURCE DiaCarta Inc.

Lead Source

DiaCarta Receives Accreditation by the College of American Pathologists (CAP)

DiaCarta, Ltd. (“DiaCarta”), a novel molecular diagnostic test developer for cancer and infectious diseases, today announced that it has received accreditation by the College of American Pathologists (CAP) for its CLIA certified lab. This accreditation is awarded to facilities that meet the high standards of quality, accuracy, and consistency in laboratory services required by CAP and underscores DiaCarta’s leadership and commitment to excellence.

DiaCarta Receives U.S. FDA Emergency Use Authorization for its Monkeypox Test Kit

DiaCarta, Ltd. (“DiaCarta”), a precision molecular diagnostics company, today announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for its QuantiVirus™ MPXV test, which is a PCR test for the qualitative detection of DNA from monkeypox virus (MPXV) in lesion swabs collected from individuals suspected of monkeypox infection.

DiaCarta Announces Successful Completion of Oncuria® Validation Study with Nonagen Bioscience

DiaCarta, Ltd. (“DiaCarta”), a precision molecular diagnostics company, and Nonagen Bioscience Corporation (“Nonagen”), a cancer diagnostics company, today announced the successful completion of the validation study of Oncuria® multiplex bladder cancer immunoassay as a laboratory developed test (“LDT”). DiaCarta also announced that it has begun receiving patient urine samples for testing in its CLIA certified lab in Pleasanton, California.

DiaCarta to Become a Publicly Listed Company Through Merger with HH&L Acquisition Co.

DiaCarta, Ltd., a precision molecular diagnostics company and developer of novel oncology and infectious disease tests, and HH&L Acquisition Co. (NYSE: HHLA.U, HHLA, HHLA WS) (“HH&L”), a publicly traded special purpose acquisition company (“SPAC”), today announced that they entered into a definitive business combination agreement (the “Business Combination Agreement”) that is expected to result in DiaCarta becoming a publicly listed company (the “Transaction” or “Business Combination”). The Transaction is expected to provide DiaCarta with access to the approximately $414 million cash from HH&L’s IPO proceeds held in trust, assuming no redemptions by HH&L’s shareholders and prior to the payment of transaction expenses, and potential additional financing to catalyze DiaCarta’s growth. The Transaction implies a pre-money equity value of $460 million for DiaCarta on a fully diluted basis and is expected to close in the first quarter of 2023. The Transaction positions DiaCarta to capitalize on significant future growth within existing and new markets.