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The MAC will consider PGx testing reasonable and necessary after a physician has narrowed a patient's treatment options to specific medications.
A bi-weekly listing of recent local coverage determinations from Medicare Administrative Contractors.
Under the LCD, pharmacogenomic tests are covered when medications are being considered for use that are known to have a clinically actionable gene-drug interaction.
The group said the recommendations aim to standardize and improve warfarin response genotyping assays.
The new distribution partnership is for the US acute care market where, until now, Spartan was selling directly.
The available data suggests PGx may be useful in managing medications for COVID-19 patients and in helping people struggling with the mental health impact of the pandemic.
The Helsinki-based firm is making its panel available for free to people who already have been genotyped by consumer genomics services or biobanks.
Invitae said YouScript and Genelex will enable it to provide pharmacogenomic testing, while Diploid will help interpret WGS results.
Regulators told the lab industry that they can continue to offer PGx lab tests without FDA approval if they make evidence-based claims.
FDA officials said at ACLA's annual meeting that the agency's efforts to balance rapid test access with safety during the coronavirus crisis carries lessons for the oversight of all tests.