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News items for the in vitro diagnostics industry for the week of March 23, 2020.
The sponsors of the VALID Act say it's time to modernize outdated diagnostic regulations slowing down test access during a public health crisis.
The agency will reimburse at about $35.91 per test for CDC assays and about $51.31 per test for non-CDC assays.
News items for the in vitro diagnostics industry for the week of March 2, 2020.
Of the 28 companies in the index, nine companies' share prices increased while the share values of 19 declined month over month.
The cell collection device already has FDA clearance, while the firm intends to conduct trials in support of a filing for marketing clearance of the assay.
A bi-weekly listing of recent local coverage determinations from Medicare Administrative Contractors.
The revisions include information on demonstrating accuracy and how to design a single set of comparison and reproducibility studies for dual 510(k) and CLIA waiver submission.
The bipartisan bill is backed by more than 250 organizations, but ACMG remains opposed, arguing that ordering tests is part of the practice of medicine.
Medicare Administrative Contractor Palmetto released its final local coverage decision last year, and WPSIC has now aligned its coverage.