MyCare Companion Diagnostics from Saladax

Bringing a research test to market as an FDA-approved, robust diagnostic test requires scientific excellence to develop the assay, expertise to navigate the clinical trial and regulatory pathway and an experienced commercialization team to coordinate a global marketing strategy for optimal market penetration.

Saladax brings a team of experts in the in vitro diagnostic development, ISO 13485:2003 certification, GMP manufacturing, clinical and regulatory expertise together with its proven and flexible technology platform to collaborative projects in the pharmaceutical arena for Companion Diagnostics (CDx).

Dr. Sal Salamone, founder and Chief Scientific Officer of Saladax, was responsible for the development and market introduction of over 70 FDA-approved assays during his tenure as Vice President of R&D at Roche Diagnostics. Ms. Adrienne Choma, President & COO, has 25 years' diagnostic experience in manufacturing and operations management, marketing & sales, and general management. The team couples its intellectual capacity, rich product development experience and quality focus from their work with the global leader in the diagnostic industry with the capacity to undertake new developmental programs and the agility to deliver new quality tests faster than would be possible by established large companies.

Talk to us about how Saladax can help you shorten your drug development cycle, reduce costs, limit risk and improve patient care through a companion diagnostic collaboration. The flexibility of the MyCare platform allows for a wide range of available partnering structures.