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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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
High Billing by Labs Continues to Be Trigger for Audits
As we move further into 2023, COVID-19, add-on, and genetic tests will likely remain targets for federal regulators.
OIG Green Lights Free Hospital NP Services for Referring Physicians
A new OIG Advisory Opinion sheds some light on how to properly structure these arrangements in a hospital inpatient setting.
Why Mobile Phlebotomy Companies and Labs Should Be on Alert
Recent fraud case involving phlebotomy company shows why labs need to pay special attention to Medicare specimen collection and travel allowance rules.
Normal Kickback and Billing Rules Return When PHE Ends on May 11
A look at the US end-of-emergency game plan and how it will impact lab compliance.
Lab Sales & Marketing Compliance: The Current State of EKRA
Sales and marketing operations liability risks and the measures labs should and shouldn’t take to manage those risks.
Lab Companies See Massive Layoffs and Restructuring
Economic volatility and uncertainty is also making a significant impact on merger and acquisition activity in the diagnostics space.
Building an Effective Business Case for Your Lab
An effective business case communicates need, benefit, and risks.
FDA Watch: 2022 510(k) Lab Test Approvals Year in Review
Abbott and Roche garnered the lion’s share of new 510(k) lab test approvals in 2022.
Labs Partner with Pharma Companies to Develop New CDx Tests
There were three notable CDx alliances announced in January 2023, all of which involved cancer-related solutions.
Digital Health Fundraising Falls in 2022 but May Not Have Bottomed Out
According to a new report, tough macro-economic conditions caused digital health fundraising levels to fall off dramatically in 2022.
