NEW YORK – DiaCarta said Monday that it has formed a strategic partnership with New Jersey-based contract research organization Hopkins MedTech Compliance/Hopkins MedTech Lab Services to provide validation and regulatory compliance services for laboratory test and in vitro diagnostic developers in the US.
The companies aim to fill an unmet need, helping companies who have developed novel IVD tests but do not have the capacity to advance their products for FDA approval or to establish them as LDTs.
"Working with DiaCarta, we can now meet the increasing demand from our customers for their LDT development needs while waiting for product approvals by the FDA," Homer Wu, CEO of HMC and HML, said in a statement.
Based in Pleasanton, California, DiaCarta has developed several blood-based molecular diagnostics using proprietary technologies for selectively amplifying target sequences. Its tests include the ColoScape colorectal cancer mutation test and the RadTox assay for personalizing radiation and chemotherapy treatment.