Press release

DiaCarta Inc. Appoints Arrow Diagnostics as Exclusive Distributor for ColoScape™ in Italy

Jul 2, 2018 | Press Releases

DiaCarta Inc is a personalized diagnostic company headquartered in Richmond, California and a leading developer of innovative, high-quality products for qPCR based assays using its proprietary QClamp® Xeno-Nucleic Acid (XNA) clamping technology, today announced that it has signed a distribution agreement with Arrow Diagnostics. Under the agreement, Arrow Diagnostics becomes sole distributor of ColoScape™ a multigene biomarker TaqMan qPCR in vitro diagnostic (CE-IVD) test in Italy, San Marino & Vatican City.

Colorectal cancer is a highly preventable disease and the detection of cancer gene mutations is not only critical for early detection of cancer development but also for targeted therapy and the monitoring of disease recurrence. This highly innovative test is configured to work both in cases where the DNA is derived from patient plasma so called “liquid biopsy” thereby requiring minimal invasive sampling making it convenient for patients and physicians and with current technology such as analysis of DNA derived from formalin fixed paraffin embedded (FFPE) tumor biopsy.

“DiaCarta is committed to working with the best distribution partners; those dedicated to customer service, cutting edge science and ultimately better patient care,” commented Aiguo Zhang, Ph.D., Founder and CEO of DiaCarta, Inc. “We are therefore delighted to have signed this agreement with Arrow Diagnostics who have a proven record of success in the highly competitive molecular diagnostics market.”

Dr. Gianluigi Mascarino, CEO of Arrow Diagnostics, said “The partnership with DiaCarta will generate significant value for our customers. We were impressed with DiaCarta’s QClamp® Xeno-Nucleic Acid (XNA) clamping technology and their commitment to innovation and especially by the flagship product, ColoScape™ CE-IVD test, which we believe will make a significant impact on colorectal cancer.”

ABOUT DIACARTA

Diacarta’s mission is to provide its customers with innovative precision molecular diagnostic tests that are faster, highly sensitive and that positively impact treatment plans and improve the well-being of patients.

DiaCarta is a translational genomics and personalized diagnostics company established in 2011, with a 16,000-square foot laboratory based in Richmond, California, housing their CLIA compliant facility, and a clinical laboratory facility in Nanjing with offices in Shanghai China. The company is well positioned as a leader in the new IVD (in vitro diagnostic) field with high precision detection of the circulating free tumor DNA (cfDNA) and is ISO13485 certified and manufactures IVD kits under cGMP such as EGFR, BRAF, KRAS, NRAS, EML4-ALK, ROS-1, PIK3CA the ColoScapeTM colorectal cancer mutation detection kits.

DiaCarta offers a range of testing services. From single-gene QClamp® qPCR tests to QClamp-NGS panels at its state-of-art CLIA certified facility.

TECHNOLOGY PLATFORM

The novel QClamp® Xeno-Nucleic Acid (XNA) clamping technology has solved the interference bottleneck of wild-type DNA in gene mutation detection and has successfully enhanced the sensitivity and specificity in the detection process. The technology can be widely used in quantitative PCR (qPCR), gene chip, nanotechnology and all generations of NGS platforms and is underpinned by over 80 patents.

ABOUT ARROW DIAGNOSTICS

Arrow Diagnostics S.r.l. was founded in 2003 and is based in Genoa, Italy. Arrow produces and distributes reagents, kits, and tools in molecular biology, virology, cell biology, microbiology, clinical diagnostics, pharmacogenetics, oncology, and immunology. It offers its products through sales representatives.

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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