To advance the regulatory science of diagnostic testing and assay development, the Medical Device Innovation Consortium (MDIC) posted a new landscape analysis report Wednesday to provide a snapshot of all known projects related to next-generation-sequencing (NGS) oncology reference samples.
The landscape analysis report serves as a catalog of information on 35 projects marked as either completed, ongoing or under development. Projects were divided into five categories—synthetic DNA, genomic DNA, cell-free DNA, human cell lines and formalin-fixed paraffin embedded. The report is the product of the first of six subgroups formed at the US Food and Drug Administration (FDA) last year under the MDIC cancer genomic somatic reference samples (SRS) project.
The SRS landscape analysis subgroup was tasked with providing an overview of projects to help avoid duplicative efforts in the space by identifying existing NGS reference samples for cancer genomic analysis, genes/variants and sample types, as well as to define unmet needs for additional genes/variants and inform other SRS subgroup efforts. It received input from a wide range of stakeholders, including the College of American Pathologists, the American Association of Cancer Research, FDA and the Centers for Medicare and Medicaid Services, among others.
The report, which includes links to more detailed information on each project, is intended for active laboratories and testing facilities, regulators, diagnostic manufacturers and end users.
Zivana Tezak, associate director for science and technology at the Office of In Vitro Diagnostic and Radiological Health within FDA’s Center for Devices and Radiological Health (CDRH), noted during an MDIC webinar on Wednesday that the SRS space is competitive but there is “usually no time or money” to advance innovation, underscoring a need to bring all stakeholders together for consensus on an SRS baseline.
CDRH officials said the report can serve as a baseline for conducting regulatory reviews of NGS-based technologies. Office of In Vitro Diagnostic and Radiological Health Director Timothy Stenzel said the review team touted the report as a “very helpful” resource for test developers looking to engage with FDA. It can be integrated as an added level of quality assurance.
The release of the report kicks off phase 2 of the MDIC SRS project, which aims to establish a collaborative effort to guide the development and availability of reference samples. This seeks greater efficiency in test development and validation and improved test reliability, accuracy and transparency. The availability of reference samples through this work will “streamline and possibly obviate steps in the regulatory process for diagnostic companies, provide transparency and compress development timelines for targeted therapeutic developers,” said Tezak.
The second phase of the project will focus on sample quality and validation as well as data integration. The business plan deliverable of phase 1 is set to be released by year’s end.
MDIC was tasked with a slew of projects and initiatives around the advancement of medical device regulatory science since the public-private partnership was first initiated by CDRH and the Medical Alley Association and established in 2012. Yet the MDIC SRS project is unique in that it is the only MDIC project that has required involvement of the pharmaceutical industry and it is chaired by JD Alvarez, Janssen’s vice president of oncology diagnostics, Tezak noted.
The work will also inform the agency’s vision for a “nimble regulatory approach” to keep pace with the field and “accelerate the translation of precision medicine technologies into treatments that benefit patients,” Stenzel noted. It comes at a time when the agency has been working to advance
legislation to establish a new risk-based framework for regulating in vitro
clinical tests (IVCT). The latest IVCT draft legislation proposes
a new precertification framework.
FDA final guidance on NGS and a draft guidance on investigational in vitro
diagnostics in oncology trials were issued
last April in support of rapid deployment and adoption of NGS-based tests. This followed on the heels of finalized
coverage policy for NGS cancer assays.