How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
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Articles and Reports
FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
Digital Health Startup Fundraising Remains Robust Despite H1 2022 Declines
According to a recent report, digital health companies are on track to rake in $21 billion for 2022, below the 2021 total of $29.1 billion.
M&A Report: Fewer Deals, Higher Impact
Continuing recent patterns, M&A deal-making in the diagnostics space was low in volume but high in impact in October.
FDA Watch: Monkeypox, COVID-19, and MDD Tests
While new test approvals were scarce in October, they were particularly impactful; here are three approvals you should know about.
Getlabs Continues In-Home Phlebotomy Services Advance
The Miami-based startup has secured major in-home phlebotomy services contracts from some of the nation’s biggest lab companies.
Labs in Court: Could Elizabeth Holmes Get a New Trial?
In this month’s roundup of key lab-related cases, a bizarre twist in the Theranos saga leads to a slim chance of a mistrial.
November 2022 Enforcement Scorecard: UDTs and Genetic Tests
Most of the recent settlements and enforcement actions involving labs related to medically unnecessary UDTs and genetic tests.
How to Use and Report ICD Codes
An overview and general briefing on some of the most common ICD codes concerns for labs.
Compliance Tool: Whistleblower Non-Retaliation Policy
How to create a written policy banning retaliation for whistleblowing and for investigating retaliation complaints.
When Qui Tam Retaliation Lawsuits Get Tricky
What happens when a compliance officer is the whistleblower in a qui tam retaliation lawsuit?
Model Policy on Employee Time Theft
This useful template can be used to develop a clear written policy on time theft for your lab in order to help prevent it.
