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Diazyme Partners with Maccura Biotechnology to Launch FDA EUA Approved SARS-CoV-2 RT-PCR Diagnostics Test

By LabMedica International staff writers
Posted on 03 Aug 2020
Diazyme Laboratories, Inc. (Poway, CA, USA) has entered into a partnership with Maccura Biotechnology (Sichuan, China) for the launch of a FDA EUA approved SARS-COV-2 RT-PCR diagnostics test.

Maccura’s SARS-CoV-2 Fluorescent PCR Kit is designed for triple-targets and is better at preventing the missed detection of SARS-CoV-2. At the same time, internal standards are added to prevent false negative test results. Clinical tests have shown that the kit has good performance, high sensitivity and specificity. The test also takes a relatively short time and can complete 96 tests within two hours.

Image: SARS-CoV-2 RT-PCR diagnostics test (Photo courtesy of Maccura Biotechnology)
Image: SARS-CoV-2 RT-PCR diagnostics test (Photo courtesy of Maccura Biotechnology)

"Here at Diazyme, we continue to address gaps in testing during the COVID-19 public health emergency. The SARS-CoV-2 Fluorescent PCR Kit- Maccura Biotechnology (USA) LLC is a RT-PCR test intended for the qualitative detection of SARS-CoV-2 viral nucleic acids in upper respiratory specimens (e.g., oropharyngeal swabs, nasopharyngeal swabs, nasal swabs, and mid-turbinate swabs) from individuals suspected of COVID-19. The demand for molecular diagnostic tests continue to outpace availability and wait times are getting too long to be meaningful in quarantine situations. We are pleased to announce our partnership with Maccura, bringing more test capacity to clinical laboratories", said Dr. Chong Yuan, Managing Director of Diazyme Laboratories, Inc.

"Maccura Biotechnology (USA) LLC is pleased to enter into a partnership with Diazyme Laboratories, Inc. providing additional testing capacity during the public health emergency in the USA. We have a long business relationship with Diazyme and continue to work together in many areas globally," said Jinson Xu, the General Manager of Maccura Biotechnology (USA) LLC.

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