FDA’s Final Rule on LDTs Vacated and New Lab Policy Updates
In a rapidly shifting regulatory landscape brought on by changes from the new Trump Administration, clinical laboratories are navigating a host of challenges ranging from legal battles over testing oversight to shrinking reimbursement rates and rising operational...
How Much Does It Cost to Build a Clinical Laboratory?
Building a clinical laboratory requires a budget for equipment, facilities, staffing, technology, regulatory requirements, and the cash needed to operate while testing volume and collections develop. Your total will depend on what you plan to test, how many samples...
How to Commercialize a Laboratory Test
UPDATE: On May 6, 2024, FDA issued a new rule amending the regulatory definition of in vitro diagnostic (IVD) device to include laboratory-developed tests (LDTs) and ending the agency’s longstanding policy of generalized enforcement discretion. However, on March 31,...
3 Things to Know When Billing for Genetic and Molecular Testing
As labs throughout the country continue to explore new revenue streams in the face of seemingly endless annual cuts from CMS and commercial payers, many are adding genetic testing and molecular diagnostics to their test menus. However, due to a patchwork of regional...
Lighthouse Acquires MJB Lab Consulting, Expanding Medical Leadership Services