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...
Maximizing the Lifespan of Your Laboratory Instrumentation
Your laboratory’s instruments play an essential role in your research, but they can also be a source of high costs. After making significant investments to acquire these pieces, your lab may also need to pay significant sums to repair and eventually replace them. This...
Navigating the Licensing and Accreditation Process for a Lab
When a new clinical lab prepares to open its doors, its owners and managers can find themselves focusing on many aspects, such as whether it has the right team members or equipment. However, you should also ensure it achieves licensing and accreditation, as these can...
Lighthouse Acquires MJB Lab Consulting, Expanding Medical Leadership Services