Research & Development
Policy & Regulation
Trends & Finance
Chembio Diagnostics obtains FDA CLIA waiver for HIV-syphilis testing system
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
Chembio Diagnostics applies for FDA CLIA waiver for HIV, syphilis test
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
Castle Biosciences Pittsburgh laboratory receives CAP accreditation
All of Castle Biosciences' laboratories are now accredited by the College of American Pathologists.
November 21, 2022
Devyser to establish lab in Georgia, seek CLIA certification
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
Nucleix announces CLIA certification, CAP accreditation for San Diego laboratory
Nucleix announced that it has received CLIA certification and CAP accreditation for its San Diego-based clinical laboratory.
October 19, 2022
Allelica launches polygenic risk score analysis as LDT
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
Quest launches long-COVID testing panels for consumers
SARS-CoV-2 infection weakens immune-cell response to vaccination, study suggests
Duke University researchers discover biomarkers may identify early pancreatic cancer risk
FDA grants 510(k) clearance to DiaSorin for COVID-19 and flu A/B assay
LumiraDx Q4 revenues drop 65% on lower COVID-19 testing
Point-of-care test developer Proxim Diagnostics obtains strategic investment from BioMérieux
TTS, OmniPathology to offer oral HPV testing in L.A.
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
Medline signs on as Visby distributor
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
OmniPathology launches lab-developed test for HPV
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
Paige links with Flagship on biomarker analysis tools
Users of Paige Platform will be able to directly launch Flagship's TissueInsight software for quantifying programmed cell death ligand 1 (PD-L1) expression in immunohistochemistry tissue samples. TissueInsight gives CLIA-reportable PD-L1 results, as well as data about the tumor microenvironment, such as information about macrophages and tumor-infiltrating lymphocytes.
February 17, 2022
Nova named president of Veracyte's CLIA U.S. business
Nova will lead all aspects of Veracyte's CLIA business for all diagnostic tests that are performed in the company's laboratories and serve physicians and their patients in the U.S. These aspects include market development, product marketing, payer reimbursement, sales, and operations.
January 6, 2022
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
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