Press release

DiaCarta Inc. Launches Ultra-Sensitive TaqMan-Based qPCR Assays for Cancer Gene Mutation Detection

Oct 29, 2018 | Press Releases

DIACARTA Inc., a precision molecular diagnostics company headquartered in Richmond, California, today 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. The tests are validated on standard real-time qPCR instruments including Thermo Fisher Scientific Quantstudio 5, Roche LightCycler® 480 and Bio-Rad CFX384. The analytical sensitivity ranges from 0.1 to 0.5% for variant allelic frequency, providing lower detection limit compared with competition due to application of DiaCarta’s proprietary XNA technology. The XNA technology selectively enriches mutant sequences while suppressing amplification of wild-type sequences, allowing identification of cancer gene mutations from small population of cells among large number of normal cells, thus making early cancer gene mutation detection possible.

High sensitivity detection of somatic cell gene mutations is not only critical for testing due to tumor tissue heterogeneity but also important for guidance in targeted therapy and monitoring of disease recurrence. DiaCarta’s highly innovative QClamp® TaqMan gene mutation tests are configured to work with DNA extracted from traditional formalin fixed paraffin embedded (FFPE) tumor biopsy samples as well as minimally invasive liquid biopsy plasma samples. LEARN MORE >

ABOUT DIACARTA

DiaCarta is a translational genomics and personalized diagnostics company based in Richmond, California with significant business operations in China. DiaCarta provides highly sensitive and advanced technologies to improve human health around the world. With over 20,000 square feet dedicated to a GMP-compliant lab space as well as CLIA and ISO 13485 certifications, DiaCarta is changing the landscape of molecular diagnostics.

DiaCarta offers research use and CE-IVD products and CLIA services for cancer gene mutation detection by leveraging different technology platforms, including single gene or small panel of genes using qPCR platform, multiple gene target detection using multiplex assays, and high-throughput next generation sequencing platforms powered by XNA technology or branched DNA technologies.

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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