CLIA: Page 3

Quidel clearance signals arrival of rapid antigen tests for coronavirus
By Emily Hayes
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
2020 05 11 20 06 1119 Quidel Sofia2 Sars 400
Sherlock's novel CRISPR coronavirus test cleared in U.S.
By LabPulse.com staff writers
The Sherlock CRISPR SARS-CoV-2 kit uses technology that programs a CRISPR molecule to identify the presence of the virus's genetic signature from a nasal swab, nasopharyngeal swab, oropharyngeal swab, or bronchoalveolar specimen. The test is designed for CLIA-certified laboratories and can provide COVID-19 diagnostic results in about one hour, according to the company.
May 6, 2020
2019 05 02 23 38 2538 Check Mark 400
GWU recruits Curative for 24-hour coronavirus testing of U.S. military
By LabPulse.com staff writers
Curative operates a CLIA-certified lab in Los Angeles, where it processes self-collected oral swab samples, with 24-hour turnaround. Per a recent agreement with the U.S. Air Force, the company will train army personnel in swab self-collection and run up to 50,000 lab tests per day. The tests will be processed in the university's Biosafety Level 2 laboratory and its department of anthropology, GWU said.
May 3, 2020
2020 05 04 20 46 5947 Military 400
Hologic debuts research-use-only SARS-CoV-2 test
By LabPulse.com staff writers
Initially, Hologic expects to distribute about 3 million of its Aptima molecular assay, which will run on the company's Panther system, to CLIA-certified hospital, public health, and reference laboratories.
April 30, 2020
2020 05 01 16 42 6378 Hologic Panther Machine Loading 400
Co-Diagnostics gets test kit manufacturing help from Promega
By LabPulse.com staff writers
Among the products set for immediate production at Madison, WI-based Promega is Co-Diagnostics' Logix Smart COVID-19 test kit, which will be made available in the U.S. and around the world. The Logix Smart COVID-19 test is currently available to all CLIA-certified clinical laboratories and is authorized for the diagnosis of SARS-CoV-2, the virus that causes COVID-19.
April 13, 2020
2020 04 14 22 00 7772 Business Men Handshake 400
Co-Diagnostics garners EUA for COVID-19 test
By LabPulse.com staff writers
Clinical laboratories certified under CLIA can now use the test to detect the novel coronavirus that causes the respiratory disease COVID-19. The company said it began offering the product to CLIA labs last month, following the FDA's relaxation of regulations on testing, which paved the way for use prior to an EUA. The test had previously received the CE Mark in Europe.
April 6, 2020
2019 05 02 23 38 2538 Check Mark 400
NeuMoDx coronavirus test gets emergency authorization
By LabPulse.com staff writers
The reverse transcription polymerase chain reaction (RT-PCR) test was designed for use on the company's high-throughput NeuMoDx 288 and 96 molecular systems in CLIA-certified hospitals and labs that perform high-complexity testing. Results are available in as little as 80 minutes, according to the company.
March 31, 2020
2019 05 02 23 38 2538 Check Mark 400
Waiver allows pathologists to work remotely during pandemic
By LabPulse.com staff writers
Through a waiver, pathologists have regulatory flexibility in terms of where they work, with temporary relief from the CLIA regulations, which require pathologists to perform diagnostic tests at certified facilities.
March 26, 2020
2020 02 25 23 24 4831 Lab Microscope Woman 400
PerkinElmer gets regulatory nod in U.S. for coronavirus test
By LabPulse.com staff writers
The agency's decision means CLIA-certified laboratories can immediately begin using the company's test kit to detect SARS-CoV-2, the virus that causes COVID-19, PerkinElmer said in a statement. The company also noted that the RT-PCR test meets the requirements of the European In Vitro Diagnostic Directive (IVDD) and is available in more than 30 countries worldwide.
March 24, 2020
2020 03 25 23 03 8557 Perkinelmer Coronavirus Boxes 20200325230253
DiaCarta files for emergency authorization of SARS-CoV-2 test
By LabPulse.com staff writers
The company noted that it has validated the novel coronavirus/COVID-19 diagnostic test in its own CLIA-certified lab in Richmond, CA, to provide testing services for healthcare providers and patients. Based on real-time polymerase chain reaction (PCR) technology, the IVD test is designed to specifically detect SARS-CoV-2 viral DNA extracted from nasopharyngeal swabs, oropharyngeal swabs, and sputum from patients suspected of being infected, according to DiaCarta.
March 23, 2020
2020 03 18 20 13 7386 Virus Coronavirus Covid 19 400
VITAL Act steps in on regulation of lab-developed tests
By LabPulse.com staff writers
Introduced by Sen. Rand Paul (R-KY), the VITAL Act also proposes ways to modernize CLIA regulations governing LDTs.
March 18, 2020
2020 03 19 18 44 4053 Washington Dc Capitol 400
FDA issues guidance on IVD tests, CLIA waivers
By LabPulse.com staff writers
One guidance document outlines final recommendations for IVD manufacturers seeking CLIA waiver applications. Waivers apply to tests that are deemed to be simple and have an insignificant risk of erroneous results under CLIA regulations. The standard for getting a CLIA waiver has been modified to indicate that the status applies when it is possible for an untrained user to obtain the result that moderately trained lab staff could achieve. Previously, CLIA waivers applied when tests are as accurate as when performed in a reference laboratory.
February 25, 2020
2019 02 13 19 24 5396 Fda Logo V2 400
Previous Page
Page 3 of 4
Next Page