Press release

DiaCarta Clinical Services Laboratory Receives CLIA Certification

Mar 28, 2016 | Press Releases

DiaCarta Inc. today announced that DiaCarta Clinical Services Laboratory (DCSL) successfully passed the State of California survey under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The State of California inspector gave DCSL permission to begin offering QClamp-based molecular diagnostic patient and clinical trial testing services.

The DiaCarta-owned and -operated laboratories, both in Richmond, California, and Nanjing, China, enable clinical and research laboratories, as well as diagnostic and pharmaceutical companies, to incorporate complex molecular tests into clinical practice. The CLIA certification ensures that all of its processes are standardized to consistently meet federal and Clinical Laboratory Standards Institute (CLSI) guidelines for accuracy, precision, sensitivity, calibration and control. In addition, all of the DCSL assays have been validated for clinical applications to ensure reproducible results.

Located in Richmond, California, DCSL is a facility of over 16,000 square feet. The laboratory specializes in patient testing and clinical trial services for gene mutation and gene expression monitoring, genotyping and copy number analysis, as well as other molecular diagnostic tests. The company is dedicated to the science of rapid, highly sensitive detection technologies and diagnostic solutions for healthcare that positively impact treatment plans and improve the wellbeing of individuals around the world. QClamp®, a revolutionary new way to screen for somatic mutations in cancer genes, utilizes a sequence-specific xeno-nucleic acid (XNA) clamp that suppresses PCR amplification on wild-type DNA template and allows selective amplification of only mutant template. With its detection sensitivity below 0.1%, QClamp® is ideal for a variety of samples including FFPE tissue, liquid biopsy and traditionally challenging cytology specimens. QClamp® on next-generation sequencing (NGS), the OptiSeq™ platform, can implement mutant DNA target enrichment to detect very low copy mutant numbers that are not possible by conventional NGS protocols.

“We are very excited about the new addition of CLIA-certified clinical laboratory testing to our suite of product offerings. Our CLIA certification is an important regulatory milestone and demonstrates our commitment to quality laboratory testing to provide accurate, reliable and timely test results,” said Dr. Aiguo Zhang, Founder and CEO of DiaCarta. “With our Independent Clinical Service Lab also in Nanjing, China, we are well positioned to become a key companion diagnostic partner with pharmaceutical companies for global clinical trials of novel targeted therapies.”

About DiaCarta Inc.
DiaCarta is a translational genomics and personalized diagnostics company headquartered in Richmond, California with business and clinical operations in Shanghai and Nanjing, China, respectively. We are dedicated to the science of rapid and highly sensitive detection technologies and diagnostic solutions for healthcare that positively impact treatment plans and improve the well-being of individuals around the world. QClamp®, a revolutionary new way to screen for tumor oncogenic driver and resistance mutations in tumor DNA derived from cancer patients, utilizes a sequence-specific xeno-nucleic acid (XNA) clamp that suppresses PCR amplification on wild-type DNA template and allows selective amplification of only mutant template with detection sensitivity below 0.1% for a variety of samples including FFPE tissue, liquid biopsy and traditionally challenging cytology specimens. The QClamp® XNA-PCR technology has also been applied for mutant DNA target enrichment on our OptiSeq™ next-generation sequencing platform. QuantiVirus™ HPV cervical cancer and DigiPlex™ genotyping tests are the products powered by SuperbDNA™ and multiplex bar-coding technology platforms, respectively. To learn more, visit https://www.diacarta.com.

Lead Source

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.

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.

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