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[Blog] Celemics NGS Panel: Excelling Under New FDA Regulations for LDTs

  • Post category:Blogs

The United States Food and Drug Administration (FDA) has recently announced a final rule over Laboratory Developed Tests (LDTs), which are a critical component of in vitro diagnostic systems. This regulatory shift emphasizes the importance of precise and reliable diagnostic methods in healthcare. LDTs refer to tests that are conceived, designed, and executed within a laboratory environment. These tests are pivotal in enhancing medical service quality and facilitating tailored treatments for patients.

Celemics offers high-quality NGS panels that can support our customers in laboratories to attain the new final rule in regards to LDT (FDA certification) by providing GMP, ISO 13485, and ISO 9001 certified NGS panels, which indicate our clinical competence to rigorous quality control and manufacturing standards. Notably, Celemics has obtained ISO 13485 certification from TÜV SÜD, a globally recognized accreditation organization known for its stringent evaluation standards. This certification reinforces Celemics’ position as a leading provider of high-quality NGS panels suitable for LDTs.

GMP is a system that ensures products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in pharmaceutical production that cannot be eliminated through testing the final product.

ISO 13485 is the internationally recognized standard for quality management systems in the medical device industry. It provides a framework to ensure the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

ISO 9001 is the world-renowned standard for quality management systems. It helps organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service.

The FDA has proposed reclassifying LDTs as medical devices, which would require them to undergo the full FDA approval process, in order to ensure the safety and efficacy of LDTs. By providing high-quality NGS panels that meet these new regulatory requirements through precise systematic quality controls, Celemics is dedicated to provide reliable diagnostic outcomes for all our customers. We are prepared to navigate and support any regulatory changes alongside our customers, striving to continually add value to their research and diagnostic processes with its NGS panels. (Contact Us)