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Results For "CLIA"

8 News Found

Visby Medical receives FDA approval and CLIA waiver for PCR sexual health test
Drug Approval | August 30, 2021

Visby Medical receives FDA approval and CLIA waiver for PCR sexual health test

The Visby Medical sexual health click test is the first instrument-free PCR test for the detection of chlamydia, gonorrhoea and trichomonas, with results available within 30 minutes, during the patient visit


Azenta obtains regulatory approval for clinical long-read whole genome sequencing test
Biotech | November 22, 2024

Azenta obtains regulatory approval for clinical long-read whole genome sequencing test

Performed within GENEWIZ from Azenta Life Sciences' CLIA-certified and CAP-accredited state-of-the-art clinical genomics laboratory


Helix and QIAGEN to jointly develop and commercialize companion diagnostics for hereditary diseases
Diagnostic Center | January 06, 2023

Helix and QIAGEN to jointly develop and commercialize companion diagnostics for hereditary diseases

Partnership to leverage the Helix Laboratory Platform and QIAGEN's biopharma relationships, NGS capabilities, and global regulatory expertise


Datar Cancer Genetics signs US $ 250 million contract with Artemis DNA
News | May 09, 2022

Datar Cancer Genetics signs US $ 250 million contract with Artemis DNA

Under the 5-year exclusive agreement, Artemis DNA will provide Datar's pioneering cancer detection Liquid Biopsies in the USA and Vietnam markets


Oncocyte completes validation of Therasure transplant monitor test
Biotech | May 08, 2022

Oncocyte completes validation of Therasure transplant monitor test

Digital PCR format allows for rapid turnaround time to facilitate fast and accurate post-transplant treatment decisions


PerkinElmer receives FDA Emergency Use Authorization for respiratory SARS-CoV-2 Panel
Medical Device | October 07, 2021

PerkinElmer receives FDA Emergency Use Authorization for respiratory SARS-CoV-2 Panel

RT-PCR test detects and differentiates SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus


US FDA grants Emergency Use Authorisation for Covid-19 pooled samples
Biotech | September 14, 2021

US FDA grants Emergency Use Authorisation for Covid-19 pooled samples

Visby Medical’s instrument-free PCR test to detect the SARS-CoV-2 virus can now be used to pool up to five patient samples using a single test