Press release

DiaCarta Obtains Exclusive License for Non-Invasive Early Detection Colon Cancer Test

Apr 17, 2015 | Press Releases

DIACARTA INC. (“DIACARTA”) and UNIVERSITY OF POTSDAM (Germany) today announced that the parties have entered into an exclusive license agreement for the development and commercialization of non-invasive early detection of colon cancer from stool samples. University of Potsdam holds awarded patent “Method for Conducting Non-Invasive Early Detection of Colon Cancer/or of Colon Cancer Precursor Cells.” Under the terms of the agreement, DiaCarta will pay Potsdam an upfront payment plus additional payments based upon achievement of commercial milestones. DiaCarta will have exclusive rights to develop and commercialize the test globally.

Some key clinical groundwork has been established by the group to develop the non-invasive diagnostic test that could be used to screen for early colorectal cancer as well as precursor lesions by detecting cancer-initiating mutations associated with colorectal cancer, which was published in Cancer Prevention Research.

“DiaCarta’s XNA Clamping technology to block all the WT-DNA is the most promising tool for the non-invasive early detection of mutations, including from liquid biopsy,” said Dr. Bettina Scholtka, assistant professor at the University of Potsdam and inventor of the patent. “We are very pleased to partner with DiaCarta to accelerate worldwide development and commercialization of Non-Invasive Early Detection of Colon Cancer.”

“With this agreement, DiaCarta now can extend its QClamp® somatic mutation test product line targeting this unmet market,” said Aiguo Zhang, PhD, DiaCarta’s Founder and CEO. “We look forward to working with Dr. Bettina Scholtka and her team at University of Potsdam to move the unique colon cancer early detection program forward as quickly as possible.”

About DiaCarta Inc.

DiaCarta, is an innovative translational genomics and precision molecular diagnostics company located in the San Francisco Bay Area. QClamp® is a rapid, sensitive qPCR based platform for detection of somatic mutations in cancer genes. The technology can also used for mutant DNA enrichment for Sanger and NGS sequencing. HPV QuantiVirus® cervical and head-neck cancer tests are based on branched DNA technology, which allow detection of oncogenic E6/E7 mRNAs from 14 high-risk subtypes and genotyping of HPV 16 and 18, directly from samples without RNA purification and RT-PCR.

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.

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