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Policy and Regulation: Page 2
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
Becton Dickinson HPV assay FDA approved with BD SurePath, Hologic ThinPrep Pap tests
The BD Onclarity HPV Assay individually tests for an extended set of HPV types, including HPV 31, which poses a higher risk for causing cervical precancer than HPV 18, Becton Dickinson said.
February 21, 2023
Qiagen obtains CE Mark for tuberculosis blood test
Qiagen’s Ipsogen JAK2 RGQ PCR kit and NeuMoDx systems and reagents have already received CE Marks under the new IVDR requirements; the firm has pledged to transition all of its products to meet the new EU IVDR regulations.
February 15, 2023
FDA grants emergency use authorization for Anavasi LAMP-based COVID-19 test, detector
Anavasi said its point-of-care platform will enable the rapid development of tests to detect viral and bacterial targets, including influenza, respiratory syncytial virus (RSV), and sexual health-related strains, among others.
February 13, 2023
Agendia MammaPrint UltraLow Risk gene signature recognized in updated NCCN guidelines
The MammaPrint 70-gene signature identifies patients at low or high risk of distant recurrence within five years of a breast cancer diagnosis.
February 13, 2023
FDA authorizes Cepheid molecular test to detect monkeypox virus at the point of care
The Xpert Mpox test is a real-time polymerase chain reaction assay to detect Mpox virus DNA in lesion swab specimens from individuals suspected of monkeypox by their healthcare provider.
February 10, 2023
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Quest launches long-COVID testing panels for consumers
Ohio, Kentucky doctors convicted in scheme to bill Medicaid for unnecessary urinalysis testing
RNA-seq analysis links protein to spread of pancreatic cancer, reveals potential drug target
Point-of-care test developer Proxim Diagnostics obtains strategic investment from BioMérieux
Quest Diagnostics offers suite of services for transplant patients and living donors
Rapid nirmatrelvir treatment in study reduced long-COVID risk
BD nabs FDA authorization for SARS-CoV-2, influenza A/B, RSV combination test
The test uses a single nasal or nasopharyngeal swab sample to identify and distinguish whether a patient has COVID-19, the flu, RSV, or some combination of the three, with results available in two hours.
February 8, 2023
UnitedHealthcare increases coverage for Guardant360 CDx liquid biopsy test
The new policy coverage by UnitedHealthcare is in addition to coverage for the liquid biopsy CDx test under UHC Medicare Advantage policies for comprehensive genomic profiling of all solid tumors.
February 8, 2023
FDA grants 510(k) clearance, CLIA waiver for BioFire multiplex respiratory panel
The FDA reviewed the BioFire test through a dual 510(k) and CLIA waiver pathway, which was designed to speed bringing accurate IVD tests to CLIA-waived settings.
February 7, 2023
LumiraDx obtains FDA authorization for test to detect flu A, flu B, SARS-CoV-2
The test leverages a single-step direct method for nucleic acid extraction and amplification on validated open RT-PCR instruments.
February 7, 2023
New York State Department of Health approves PreciseDx breast cancer LDT
With the approval, PreciseDx can begin testing patient samples using its PDxBr test in the state of New York through its CLIA-certified laboratory.
February 7, 2023
Study suggests race adjustment unnecessary for alpha fetoprotein prenatal testing
Researchers recommend that a longstanding race-based adjustment to test-result values of alpha fetoprotein from a common prenatal screening should be discontinued.
February 6, 2023
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