Research & Development

The new initiative will aim 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 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 characterised, 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 fulfil this need,” said Wendy Rubinstein, MD, PhD, Director, Personalised Medicine, Centre for Devices and Radiological Health, FDA.

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.