Roche Molecular Systems’ cobas SARS-CoV-2 and Influenza A/B Nucleic Acid Test is for use on the cobas Liat System. The false positive results may be related to two issues observed by Roche.
The FDA has issued and immediately implemented a new guidance: Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
The template will help developers submit EUA requests for covid-19 diagnostics that can be performed entirely in settings such as homes, offices, or schools.
Final 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.
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The Cloud-based solution automates the analysis of next-generation sequencing data for liquid biopsy and FFPE workflows.
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AMP President Victoria M. Pratt, PhD, discusses the association’s updated position statement on consumer genomic testing.
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.
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The smartphone-based system supports home-use urinalysis testing, increasing consumer access to albumin:creatinine ratio testing.
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