Press release

DiaCarta Introduces QFusion™ Single-Tube qPCR Assay for ALK Fusion Gene Detection

Sep 26, 2016 | Press Releases

DiaCarta today announced the introduction of QFusion™ RT-qPCR assay, a new product for the comprehensive, rapid and reliable detection of ALK fusion gene variants. The assay enables users to detect ten EML4-ALK and three KIF5B-ALK fusion gene variants in a single tube of multiplexed reactions with only 50 ng of RNA from FFPE samples in approximately 1.5 hours. It addresses critical issues in fluorescence in situ hybridization (FISH), the “gold standard” technique in fusion gene analysis, by eliminating objective interpretations of chromosomal break-apart patterns and reducing turnaround time by more than ten-fold.

Joining QClamp® EGFR and KRAS gene mutation detection kits in the DiaCarta’s lung cancer panel, the QFusion™ assay provides researchers and pathologists with a new tool to expand and accelerate their research in non-small cell lung cancer (NSCLC). The assay is the only commercial qPCR kit on the market that detects both EML4-ALK and KIF5B-ALK fusion gene variants, covering 95% of EML4-ALK and 90% KIF5B-ALK variants found in the COSMIC database for NSCLC. QFusion™ ALK generates highly specific results and accurately detects as low as 50 fusion templates in each reaction.

“I am excited about the launch of our QFusion™ ALK fusion gene detection assay. It is a best in class product that provides comprehensive, rapid and robust detection of not only the widely studied EML4-ALK but also the novel KIF5B-ALK fusion genes. Our one-tube assay is an alternative to the laborious slide-based ALK fusion gene assays, especially FISH, and it is designed to improve the quality and productivity of NSCLC research in many labs where real-time PCR machines are routinely used,” said Michael Powell, Ph.D., Chief Scientific Officer of DiaCarta. “As an innovator in precision molecular diagnostics, DiaCarta is uniquely positioned to deliver advanced solutions for cancer research and diagnostic applications. Among a suite of tests that we are planning to launch within the next year, QFusionTM ALK is one of them, and it has been designed and developed in our CLIA- and ISO 13485-certified facility.”

About DiaCarta, Inc.

Headquartered in Richmond, California with an ISO 13485-certified facility, DiaCarta develops, manufactures and markets cancer research and IVD products for precision molecular diagnostics. We specialize in genomic testing for biomarkers and offer clinical sample testing services in our CLIA-certified lab. We have also established our business operations and clinical service lab in Shanghai and Nanjing, China, respectively. QClamp® and OptiSeq™ are xeno nucleic acid (XNA) based technologies that enable highly sensitive detection of actionable mutations using qPCR and next-generation sequencing (NGS) platforms, respectively, for liquid biopsy and other traditionally challenging specimens. Other XNA applications include CRISPR/Cas9 gene-editing event screening and adapter dimer removal for NGS library preparation. 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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