October 2023 Labs in Court
Recent cases involve charges and judgments related to COVID-19 add-on tests, genetic testing fraud, and kickbacks.
Diagnostic Testing and Emerging Technologies
LAB COMPLIANCE ADVISOR
LABORATORY INDUSTRY REPORT
NATIONAL LAB REPORTER
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Recent cases involve charges and judgments related to COVID-19 add-on tests, genetic testing fraud, and kickbacks.
With recent test recalls announced by Universal Medtech and QuidelOrtho, such products now make up one-third of 2023 total recalls listed by the FDA.
The new rule put forth by the FTC and DOJ would make mergers and acquisitions much more difficult to achieve.
While overpayments may not be your fault, they expose your lab to the risk of liability under the Affordable Care Act.
Performing your own audit to verify compliance and identify problems is one key to achieving a successful FDA audit.
In last month’s key cases, Illumina and Guardant seek to dismiss lawsuit related to trade secrets and breach of contract.
A strategic partnership with Google enables more accurate whole genome sequencing with machine learning.
More multiplex COVID-19 combination tests emerge from premarket authorization pipeline.
Seven months into the year, there were already four reported deals valued at over $1 billion in 2023, as many as in all of 2022.
Proposed rule would require businesses to undergo even more stringent review to secure regulatory approval for such deals.