DiaCarta Receives U.S. FDA Emergency Use Authorization for its Monkeypox Test Kit
PLEASANTON, Calif., Jan. 12, 2023 (GLOBE NEWSWIRE) -- 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 QuantiVirusTM 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.
The test is designed for use by authorized laboratories on the most popular qPCR instruments, including the Thermo Fisher (ABI) QuantStudio5, Thermo Fisher (ABI) 7500 Fast Dx, Bio-Rad CFX384, and Roche LightCycler 480 II Systems.
QuantiVirusTM MPXV test targets two different regions of the MPXV genome, following recommendations from the CDC, which are both less prone to mutations than other parts of the genome. This dual-target approach is designed to help QuantiVirusTM MPXV continue to detect the virus even if a mutation occurs in one of the target regions.
"I am very proud of our speed, dedication and ability to develop the QuantiVirusTM MPXV test, which now places us at the forefront of combating potential problems from Monkeypox," said Adam (Aiguo) Zhang, CEO of DiaCarta. "When cases of the Monkeypox virus infection were initially reported, DiaCarta quickly allocated resources to develop a test kit that could meet the testing needs and provide an easy, safe, and reliable testing solution. Through our proprietary technology, we developed the QuantiVirusTM MPXV test as a high-throughput solution on an open qPCR system to better serve patients and healthcare providers."
The high-throughput solution on an open qPCR system allows labs to more easily adopt the test and helps individuals get accurate results quickly, eliminating instances of unnecessary additional testing or isolation and allowing patients to have access to appropriate treatment as soon as possible.
About monkeypox
Symptoms of monkeypox include fever, chills, headaches, muscle aches, fatigue, swollen lymph nodes and a painful rash that characteristically appears as raised bumps on the skin and tends to be distributed on the face, extremities, and genitals. As the disease progresses, these bumps fill with pus and fluid and become umbilicated. They will eventually ulcerate, scab, and fall off.
About DiaCarta
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 SuperbDNA™ 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.
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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.
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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.
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