In Vitro Diagnostics

Representative experience

Help develop clinical and regulatory strategies for a number of clients that are developing biomarkers and molecular diagnostics that would be companion assays to drugs.

Worked on numerous pre-market submissions for IVDs in the medical device and biologics areas and on Investigational New Drug (IND) applications for various imaging agents.

Assist IVD and reagent manufacturers, as well as clinical laboratory service providers, in navigating the parallel universes of IVD and analyte-specific reagent regulation and laboratory-developed tests.

We have established regulatory training programs to educate the internal units of major companies on the development, testing requirements, premarket submissions, and manufacturing requirements regarding QSRs.

We assisted a company in obtaining the first waiver from the FDA under the Clinical Laboratory Improvement Amendments (CLIA) for a syphilis screening test.

Assisted T2 Biosystems, Inc. in preparing a direct de novo product authorization petition for the company’s T2 Candida diagnostic test system.

Assisted with preparing and obtaining FDA approval for the first non-invasive screening test for colorectal cancer that analyzes both stool DNA and blood biomarkers.