Initiative to improve next generation cancer diagnostics

pharmafile | August 23, 2022 | News story | Manufacturing and Production  

The Medical Device Innovation Consortium (MDIC) has formally launched its Somatic Reference Samples (SRS) Initiative with a pilot project, aiming to improve the validation and regulatory review process for sequencing-based cancer diagnostics.

The initiative will seek to develop, manufacture, and validate publicly available somatic reference samples, and create public genomic datasets with the potential to be used by sponsors and regulators.

Next generation sequencing (NGS) is a parallel sequencing technology that offers extremely high throughput, scalability, and speed.

“Through the MDIC SRS Initiative, we are developing reference samples and data sets that can be used globally by test developers and regulators to bring more consistency to NGS-based cancer diagnostic development, increasing the confidence and accuracy of these tests, which will ultimately lead to more accuracy in diagnosis and treatment for patients,” said Andrew Fish, President and CEO, MDIC.

MDIC will lead a collaboration with the US FDA, the National Institute of Standards and Technology (NIST), National Institutes of Health (NIH), and industry stakeholders to manufacture, validate, and distribute SRSs to simplify and support validation of NGS-based cancer diagnostics.

“There is a need for appropriately consented, highly characterized, and broadly available reference materials that may improve the accuracy, reliability, and transparency of NGS-based oncology tests and support the generation of validation data for use in regulatory submissions. The reference samples and datasets being created by the MDIC Somatic Reference Samples Initiative can help fulfill this need,” said Wendy Rubinstein, MD, PhD, Director, Personalized Medicine, Centre for Devices and Radiological Health, U.S. Food and Drug Administration.

The initiative also includes the goal to create a publicly available global genomic data resource library of datasets with the potential to be used by sponsors and regulators.

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