PLEASANTON, Calif.--(BUSINESS WIRE)--DiaCarta, Ltd. (“DiaCarta”), a novel molecular diagnostic test developer for cancer and infectious diseases, today announced that the company has formed strategic partnership with New Jersey-based Hopkins MedTech Compliance (HMC) and Hopkins MedTech Lab Services (HML) to support the unmet needs for regulatory compliance and laboratory developed test (LDT) validation of in vitro diagnostics (IVD) in the United States. The partnership will help companies who have developed novel IVD tests but do not have the capacity to bring the products for FDA approval, or to take the tests to clinical labs to serve healthcare providers and patients.
“We have built a strong customer base in the IVD field, which relies on our expertise for clinical trials and regulatory filings, such as FDA Emergency Use Authorization (EUA), 510(k), PMA, and De Novo applications,” said Dr. Homer Wu, CEO of HMC and HML. “DiaCarta has established high-quality systems not only for its IVD products under ISO13485 compliance, but also the LDT testing venues at its CAP/CLIA lab in California. 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.”
“We are very glad to partner with HMC/HML to help more companies develop and validate LDTs for clinical testing,” said Dr. Adam (Aiguo) Zhang, CEO and President of DiaCarta. “Not only do we have successful experiences validating LDT assays for our clients, DiaCarta has also closely worked with CMS for coding, billing and reimbursement of the new tests.”
Both DiaCarta and HMC/HML will attend 2023 AACC Annual Scientific Meeting and Clinical Lab Expo on July 23 to 27, Anaheim, California. Their products/services will be presented at booths #4451 for DiaCarta and #3474 for HMC/HML.
About DiaCarta
DiaCarta is a molecular diagnostics company that has developed innovative technologies to transform patient care by providing effective precision diagnostics using liquid biopsy. Its novel XNA technology is designed to provide a high level of sensitivity as it binds to the wild-type sequence, to enable only the mutant target sequence to be amplified. Using this technology, DiaCarta has developed its ColoScape™ colorectal cancer mutation test. Powered by its isorbDNA™ technology that amplifies the signal and requires no RNA/DNA extraction or amplification, DiaCarta has developed its RadTox™ test to personalize radiation and chemotherapy, mitigate adverse events and enhance patient care. Based in Pleasanton, California, DiaCarta is ISO-certified, GMP-compliant, and offers CAP/CLIA certified laboratory services to its customers. www.diacarta.com
About HMC/HML
Based in New Jersey, Hopkins MedTech Compliance (HMC) is a Contract Research Organization (CRO) specializing in clinical trials and regulatory compliance for medical devices and in vitro diagnostic in the US and European markets. We offer a full range of clinical trial services required for FDA registration in the United States and IVDR certification in Europe. Our expertise spans from clinical protocol development to clinical trial execution and clinical report writing. HMC also offers a comprehensive suite of certification services. We assist clients in navigating the regulatory landscape by providing end-to-end support for various regulatory submissions. This includes FDA Emergency Use Authorization (EUA), 510(k), PMA, and De Novo applications, as well as European IVDR through Notified Body (NB) registration.
Hopkins MedTech Lab Services (HML) is a trusted partner and supplier of comprehensive laboratory solutions dedicated to IVD developers, clinical laboratories, and life science researchers nationwide. With recent rapid advances in clinical genomics and precision diagnostics, HML has successfully cultivated an expansive portfolio of adaptable, patient-mimicking reference materials, LDT reagents, innovative diagnostic equipment, and laboratory quality control programs. We partner with over 62,000 Clinical Laboratory Improvement Amendments (CLIA) labs in the United States, offering a wide range of services and products designed to foster clinical accuracy and innovation. HML also owns and operates two CLIA laboratories in New Jersey, further underlining our deep commitment to clinical excellence. We are constantly seeking new ways to advance clinical practice through cutting-edge technology and state-of-the-art services.
