The final decision includes some changes, most notably removing requirements for guideline inclusion, but retains its technical performance benchmarks.
The firm will scale US-based testing capacity for its LiquidHallmark liquid biopsy assay, which uses amplicon-based technology to detect cancer-related mutations.
Amid increasing spending on genetic testing, there are more opportunities for bad actors to implement interstate, fraudulent billing schemes, according to OIG.
New CMS billing rules and the rise of COVID-19 case numbers makes managing SARS-CoV-2 test turnaround times even more urgent for clinical laboratories.
The company is drawing on its previous experience developing and commercializing its HIV self-test to make progress on a test that could be used for three different indications.
The COVID-19 pandemic is the highest priority for most, but laboratory organizations are also looking ahead with longer-term goals for the new presidency.