CLIA: Page 2

FDA clears Visby Medical's sexual health test
The agency has also granted Visby Medical a waiver under CLIA for the test, the company said. The CLIA waiver allows facilities with CLIA certification to administer the test during a patient's appointment. The test is performed using a self-collected vaginal swab, and results are ready within 30 minutes.
August 29, 2021
2020 08 06 00 13 1401 Neisseria Gonorrhoeae 400
Dalrada, Vivera form diagnostic lab joint venture
The CLIA-certified lab will provide full onsite COVID-19 testing services for high-volume settings such as businesses, conventions, the hospitality industry, and schools. The initial focus will be on rapid antigen testing and lab-based polymerase chain reaction (PCR) testing for COVID-19, with PCR test results provided within 24 hours, the companies said.
August 9, 2021
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FDA grants EUA for Diabetomics' SARS-CoV-2 Ab test
The CovAb test only requires an oral fluid sample obtained with a simple swab of the gumline, making it easy and painless, the company said in a statement. The test is CLIA-waived, is all-inclusive, and does not require any additional components or instrumentation, Diabetomics said. Test results reportedly are available within 15 minutes.
June 23, 2021
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NowDiagnostics gets EUA for point-of-care COVID test
AdexusDx is designed for use in moderate-complex settings and at the point of care, according to NowDiagnostics. The company said the test can be used in a variety of CLIA-waived healthcare settings that include pharmacies, clinics, and hospital emergency rooms.
May 27, 2021
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FDA clears Binx Health's chlamydia, gonorrhea POC assay
The FDA granted a waiver under the CLIA of 1988 allowing the assay to help with swift and appropriate treatment of sexually transmitted infections, Binx said.
April 1, 2021
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Lucence, Waseda University partner on liquid biopsy test
Lucence believes the technology could be used in potential applications in early cancer detection and disease monitoring. Lucence plans to commercialize the liquid biopsy platform from its CLIA-licensed laboratory in Palo Alto.
March 23, 2021
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Veracyte completes Decipher acquisition for $600M
Tina Nova, PhD, who is the previous president and chief executive officer at Decipher, has been appointed general manager of urologic cancers at Veracyte. She will continue to oversee the company's San Diego operations, including a CLIA-certified and College of American Pathologists (CAP)-accredited laboratory.
March 14, 2021
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FDA grants EUA to Kantaro for COVID-19 serology test
The COVID-SeroKlir is a semiquantitative SARS-CoV-2 immunoglobin G (IgG ) antibody test kit that determines the presence and precise levels of IgG antibodies in samples and can be used in any CLIA-certified lab. The test, which is a joint venture among Kantaro, Mount Sinai Health System, and RenalytixAI, demonstrated 98.8% sensitivity and 99.6% specificity for detecting SARS-CoV-2 specific IgG antibodies against two virus antigens, the full-length spike protein, and its receptor-binding domain, according to the firm.
November 24, 2020
2020 09 08 20 55 7263 Fda Drugs Approval 400
CMS debuts new guide to streamline CLIA process for COVID-19
The quick-start guide helps laboratories with the application process and includes information on the expedited review process. Labs also have a new option to pay CLIA certification fees on the CMS CLIA program website. Payments on the website are processed overnight, significantly faster than processing of hard-copy checks.
September 24, 2020
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ZRT launches dried blood antibody tests for SARS-CoV-2
The tests require a healthcare professional to perform a finger prick and place a few blood drops onto a filter card. Once dry, the card is shipped with coolants to ZRT's CLIA-certified laboratory for testing. One was developed by Euroimmun and targets the SARS-CoV-2 spike-S1 protein; this product has an emergency use authorization in the U.S. The other was developed by Epitope Diagnostic and targets the nucleocapsid protein; emergency clearance in the U.S. is pending.
July 9, 2020
2020 06 17 20 35 0417 Covid 19 Antibody 400
Sekisui secures FDA clearance, CLIA waiver for rapid flu antigen test
Utilizing traditional lateral flow technology, the test kit is designed for qualitative detection of influenza type A and type B nucleoprotein antigens from nasal or nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. The company noted the importance of being able to rule flu in or out in the process of assessing patients for other respiratory infections during the COVID-19 pandemic.
June 8, 2020
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Quidel clearance signals arrival of rapid antigen tests for coronavirus
Quidel's Sofia 2 SARS antigen point-of-care (POC) test is designed for use with the company's Sofia 2 fluorescent immunoassay analyzer. On May 9, the FDA granted emergency use authorization (EUA) for the test for use by CLIA-certified moderate- and high-complexity labs and facilities that have a CLIA waiver.
May 10, 2020
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