The FDA is monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests.
The page offers resources such as emergency use authorization templates and FAQs regarding surveillance testing and the testing of asymptomatic individuals.
Four companies unite to form Discovery Life Sciences.
The waiver will provide temporary relief from federal regulations requiring pathologists to render primary diagnoses onsite at healthcare facilities.
Read MoreCMS has issued a change request to inform Medicare administrative contractors about new HCPCS codes that are subject to and excluded from CLIA edits.
Read MoreFinal rules require access to health information, spur innovation, and aim to end information blocking.
Read MoreFDA and the Federal Trade Commission (FTC) issued warning letters to seven companies for selling fraudulent COVID-19 products.
Read MoreFDA has recently issued two guidance documents for developers of in vitro diagnostics.
Read MoreIllumina has filed two additional patent infringement suits relating to BGI’s sequencing products. Related patent suits are pending in Denmark, Germany, Switzerland, Turkey and the United States.
Read MoreNow is the time to make sure that hospital executives are fully educated about details of the Protecting Access to Medicare Act of 2014.
Read MoreLaboratories that meet CMS criteria must collect their private payor data for the first half of 2019, and report it to CMS no later than March 31, 2020.
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The federal law comes with significant cuts to Medicare testing fees, but labs that take steps now will be better able to meet the challenge.
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The renewal applies to specialties that include clinical chemistry, diagnostic immunology, hematology, immunohematology, and microbiology.
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The agency’s exemption would apply only to cytometry instruments used for counting or characterizing cells.
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The emergency diagnostics taskforce will help to prepare the agencies to respond during public health emergencies.
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VisualStrata is a precision medicine informatics platform that uniquely integrates diagnostic, clinical, and financial data to support value-based care initiatives.
Read MoreIncreasing preference for self-diagnosis continues to be a trigger for the sale of home-use diagnostics, but a wide variety of industry-specific and regulatory factors are influencing the strategies of market players.
Read MoreOrtho Clinical Diagnostics has announced an international distribution and copromotion agreement with Thermo Fisher Scientific, to provide 14 assays for use in monitoring therapeutic drugs, immunosuppressive drugs, and drugs of abuse.
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