DiaCarta Receives U.S. FDA Emergency Use Authorization for its Monkeypox Test Kit
DiaCarta, a precision molecular diagnostics company, received Emergency Use Authorization (EUA) from the FDA for its QuantiVirus MPXV test, designed to detect monkeypox virus DNA in lesion swabs. This PCR test can be utilized on several popular qPCR instruments and targets two regions of the MPXV genome, enhancing its mutation resistance. The high-throughput solution facilitates lab adoption, ensuring quick and accurate results for patients. DiaCarta's CEO emphasized their rapid response to the monkeypox outbreak, underscoring the test's reliability and accessibility.
- FDA granted Emergency Use Authorization for QuantiVirus MPXV test.
- Test designed for use with popular qPCR systems improves accessibility.
- Dual-target approach enhances detection reliability amid potential mutations.
- None.
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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Company Contact:
Anne Vallerga PhD, MBA
VP, External Affairs
annek@diacarta.com
PR Contact:
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VP, Public Relations
jsparano@peregrinemarketaccess.com
Investor Contact:
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Gateway Investor Relations
(949) 574-3860
DiaCarta@GatewayIR.com
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