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.
“This CAP Accreditation is a tremendous accomplishment that signifies DiaCarta’s commitment to excellence and I am proud of our team’s dedication in support this major milestone,” said Zheng Li, Vice President of Medical Clinical Affairs at DiaCarta. “This achievement reflects our continued adherence to the highest standards of quality, accuracy and consistency in providing clinical diagnostic tests to patients and clinical communities and builds on the success of our recently won New York State CLIA license.”
The U.S. federal government recognizes the CAP Laboratory Accreditation Program as being equal-to or more-stringent than the government’s own inspection program. During the CAP inspection process, inspectors examine the laboratory’s quality system and records. Included in the inspection is the examination of laboratory staff qualifications, laboratory equipment, safety programs, and overall management practices.
DiaCarta is a molecular diagnostics company that has developed innovative technologies to transform patient care by providing effective precision diagnostics using liquid biopsy. Its novel XNA technology is designed to provide a high level of sensitivity as it binds to the wild-type sequence, to enable only the mutant target sequence to be amplified. Using this technology, DiaCarta has developed its ColoScape™ colorectal cancer mutation test. Powered by its isorbDNA™ technology that amplifies the signal and requires no RNA/DNA extraction or amplification, DiaCarta has developed its RadTox™ test to personalize radiation and chemotherapy, mitigate adverse events and enhance patient care. Based in Pleasanton, California, DiaCarta is ISO certified, GMP-compliant, and offers CLIA certified laboratory services to its customers. www.diacarta.com
On October 14, 2022, DiaCarta and HH&L Acquisition Co. (NYSE: HHLA), a special purpose acquisition corporation, entered into a definitive business combination agreement that would result in DiaCarta becoming a public company.
About the College of American Pathologists
As the world’s largest organization of board-certified pathologists and a leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, read the CAP Annual Report at cap.org.
Important Additional Information Will Be Filed with the SEC
This communication relates to the proposed business combination between HH&L and DiaCarta (the “Business Combination”). HH&L has filed a preliminary, and will file a definitive, proxy statement, which will include a prospectus, which will be a part of a registration statement, and other relevant documents with the SEC. This communication does not contain all the information that should be considered concerning the proposed Business Combination and is not intended to form the basis of any investment decision or any other decision in respect of the Business Combination. HH&L’s and DiaCarta’s shareholders and other interested persons are urged to read the proxy statement/prospectus and any other relevant documents filed with the SEC when they become available, and any amendments thereto, because, among other things, they will contain updates to the financial, industry and other information herein as well as important information about HH&L, DiaCarta and the contemplated Business Combination. When available, the definitive proxy statement/prospectus and other relevant materials for the proposed Business Combination will be mailed to shareholders of HH&L as of a record date to be established for voting on the proposed Business Combination. Shareholders will be able to obtain a free copy of the proxy statement/prospectus (when filed), as well as other filings containing information about HH&L, DiaCarta and the proposed Business Combination, without charge, at the SEC’s website located at www.sec.gov or by directing a request to: HH&L Acquisition Co., Suite 2001-2002, 20/F, York House, The Landmark, 15 Queen’s Road Central, Central, Hong Kong. Investment in any securities described herein has not been approved or disapproved by the SEC or any other regulatory authority nor has any authority passed upon or endorsed the merits of the Business Combination or the accuracy or adequacy of the information contained herein. Any representation to the contrary is a criminal offense.
This communication contains certain statements, estimates, targets, forecasts, and projections with respect to HH&L or DiaCarta. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements include, without limitation, statements regarding the estimated future financial performance and financial position of DiaCarta. Future results are not possible to predict. Opinions and estimates offered in this communication constitute DiaCarta’s judgment and are subject to change without notice, as are statements about market trends, which are based on current market conditions. You can identify these forward looking statements through the use of words such as “may,” “will,” “can,” “anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,” “seek,” “estimate,” “continue,” “plan,” “point to,” “project,” “predict,” “could,” “intend,” “target,” “potential” and other similar words and expressions of the future, but the absence of these words does not necessarily mean that a statement is not forward-looking. Such forward-looking statements are based on estimates, assumptions and factors that are inherently uncertain, that are beyond DiaCarta’s control or ability to predict and that could cause actual results to differ materially from expected results. As a result, they are subject to significant risks and uncertainties and actual events or results may differ materially from these forward-looking statements. No reliance should be placed on any forward-looking statements, including any projections, targets, estimates or forecasts contained in this communication. Any forward-looking statement speaks only as of the date on which it was made, based on information available as of the date of this communication, and such information may be inaccurate or incomplete. Products described by DiaCarta in its pipeline are under investigation and have not been proven to be safe or effective, and there is no guarantee any such product will be approved in the sought-after indication or will meet the developmental milestones set forth herein, including within the timeline set forth herein. Neither DiaCarta nor HH&L undertakes any obligation to release any revisions to such forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Information regarding performance by, or businesses associated with, our management team or businesses associated with them is presented for informational purposes only. Past performance by DiaCarta’s management team and its affiliates is not a guarantee of future performance. Therefore, you should not rely on the historical record of the performance of DiaCarta’s management team or businesses associated with them as indicative of DiaCarta’s future performance of an investment or the returns DiaCarta will, or is likely to, generate going forward.
Participants in the Solicitation
HH&L and its directors and executive officers may be deemed to be participants in the solicitation of proxies from HH&L’s shareholders in connection with the proposed Business Combination. A list of the names of HH&L’s directors and executive officers and information regarding their interests in HH&L is contained in HH&L’s Annual Report on Form 10-K, which was filed with the SEC on March 30, 2022, and is available free of charge at the SEC’s website at www.sec.gov, or by directing a request to HH&L Acquisition Co., Suite 2001-2002, 20/F, York House, The Landmark, 15 Queen’s Road Central, Central, Hong Kong. Additional information regarding the interests of any such participants will be contained in the proxy statement/prospectus for the proposed Business Combination when available.
DiaCarta and its directors and executive officers may also be deemed to be participants in the solicitation of proxies from the shareholders of HH&L in connection with the proposed Business Combination. A list of the names of such directors and executive officers and information regarding their interests in the proposed Business Combination will be included in the proxy statement/prospectus for the proposed Business Combination when available.
The definitive proxy statement/prospectus will be mailed to shareholders as of a record date to be established for voting on the proposed Business Combination when it becomes available. Shareholders, potential investors and other interested persons should read the proxy statement/prospectus carefully when it becomes available before making any voting or investment decisions.
No Offer or Solicitation
This communication is for informational purposes only and does not constitute (i) a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the Business Combination, (ii) an offer or invitation for the sale or purchase of the securities, assets or business described herein or a commitment of HH&L, DiaCarta or any of their respective subsidiaries, stockholders, affiliates, representatives, partners, directors, officers, employees, advisers or agents, with respect to any of the foregoing, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction, and this press release shall not form the basis of any contract, commitment or investment decision and does not constitute either advice or recommendation regarding any securities.
Anne Vallerga PhD, MBA
VP, External Affairs
VP, Public Relations
Cody Slach, Matthew Hausch
Gateway Group, Inc.
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