CLIA

Missing your CLIA certificate?
By LabPulse.com staff writers
CMS might not have sent you a paper document.
August 27, 2024
Cms Clia Application Snippet82724
CMS final rule settles controversial proposal
By Liz Carey
A year-end final rule from the Centers for Medicare and Medicaid Services (CMS) settled a contentious proposal to include nursing degrees in the qualifications for high-complexity testing personnel under CLIA of 1988 regulations.
January 4, 2024
Regulation Wheel Social
BioMérieux receives FDA CLIA waiver for multiplex PCR respiratory panel
By LabPulse.com staff writers
In about 15 minutes, the panel detects five of the most common viral causes of upper respiratory tract infections: SARS-CoV-2, influenza A, influenza B, respiratory syncytial virus (RSV), and rhinovirus.
May 11, 2023
Patient Doctor Women Social
Chembio Diagnostics obtains FDA CLIA waiver for HIV-syphilis testing system
By LabPulse.com staff writers
More than 200,000 CLIA-waived point-of-care testing sites in the U.S. can now use the system to detect HIV and syphilis, Richard Eberly, Chembio’s president and CEO, said in a statement.
February 24, 2023
Hiv Virions Cdc Social
Chembio Diagnostics applies for FDA CLIA waiver for HIV, syphilis test
By LabPulse.com staff writers
Using a small blood sample, the test detects antibodies for HIV types 1 and 2 as well as Treponema pallidum, the bacteria that causes syphilis.
November 28, 2022
Infectious Diseases Research Social
Castle Biosciences Pittsburgh laboratory receives CAP accreditation
By LabPulse.com staff writers
All of Castle Biosciences' laboratories are now accredited by the College of American Pathologists.
November 21, 2022
Women Laboratory Social
Devyser to establish lab in Georgia, seek CLIA certification
By LabPulse.com staff writers
The laboratory would enable it to obtain control of selling tests, ensure value-based pricing and improved margins, and conduct closer interaction with physicians and patients, the firm said.
November 9, 2022
Lab Equipment Drug Manufacturing Social
Nucleix announces CLIA certification, CAP accreditation for San Diego laboratory
By LabPulse.com staff writers
Nucleix announced that it has received CLIA certification and CAP accreditation for its San Diego-based clinical laboratory.
October 19, 2022
Digital Science Lab
Allelica launches polygenic risk score analysis as LDT
By LabPulse.com staff writers
The firm said its tests are made possible through a partnership with Clinical Enterprise, a CLIA-certified, CAP-accredited laboratory located in Framingham, MA.
September 20, 2022
2022 08 23 15 47 2774 Dna Sequencing Data Analysis 400
TTS, OmniPathology to offer oral HPV testing in L.A.
By LabPulse.com staff writers
A throat swab enables the detection of 14 high-risk strains of HPV by pathologists at OmniPathology's high-complexity, CLIA-certified pathology laboratory in Pasadena, CA.
August 16, 2022
2019 05 17 20 09 8391 Hpv 400
Medline signs on as Visby distributor
By LabPulse.com staff writers
A handheld PCR test with a CLIA waiver, the all-in-one unit can provide diagnostic test results in under 30 minutes for sexually transmitted infections in women, the firms said.
August 1, 2022
2022 08 02 20 09 1944 Lab Std Test 400
OmniPathology launches lab-developed test for HPV
By LabPulse.com staff writers
The PCR-based test detects 14 high-risk strains of HPV, a virus with potential to progress to cancer. It is performed on a throat swab submitted for testing to OmniPathology's CLIA-certified laboratory in Pasadena, CA, and helps screen for oropharyngeal cancer and early premalignant lesions.
July 11, 2022
2019 05 15 20 52 2340 Lab Pcr Tubes Dna 400
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