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The owner of Specialty Drug Testing, a Monroe, Louisiana-based laboratory, appeared in United States District Court accused of violating the Anti-Kickback Statute.
The community is poised to be the primary channel for stakeholders to communicate PGx concerns with FDA, but it is unclear if all stakeholders will participate.
The firm can now tell customers if their genotypes may impact their response to clopidogrel and citalopram without the need for confirmatory testing.
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.