DiaCarta Inc., a leading molecular diagnostic test developer for cancer and infectious diseases, has announced a strategic partnership with Hopkins MedTech Compliance (HMC) and Hopkins MedTech Lab Services (HML) to address the regulatory compliance and laboratory developed test (LDT) validation needs in the United States. This collaboration aims to provide support to companies that have developed innovative in vitro diagnostics (IVD) tests but lack the resources to navigate FDA approval or bring their tests to clinical labs.
According to Dr. Homer Wu, CEO of HMC and HML, DiaCarta's expertise in clinical trials and regulatory filings, including FDA Emergency Use Authorization (EUA), 510(k), PMA, and De Novo applications, will be instrumental in meeting the growing demand from customers for LDT development while awaiting FDA product approvals.
Dr. Adam (Aiguo) Zhang, CEO and President of DiaCarta, expressed enthusiasm about partnering with HMC/HML to assist more companies in developing and validating LDTs for clinical testing. He also highlighted DiaCarta's successful track record in