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Memorandum of Understanding signed by NCI, FDA and HRSA to bring cancer diagnostic devices closer to patients, particularly members of medically underserved and geographically isolated communities

On Friday, September 17, 2021, leadership from the National Cancer Institute (NCI), Food and Drug Administration (FDA), and Health Resources and Services Administration (HRSA) signed a Memorandum of Understanding (MOU) to support solutions for early cancer detection and diagnosis to improve patient outcomes, quality of life, and reduce health disparities among medically underserved, geographically isolated, and otherwise vulnerable populations.

This new MoU Signing ImageMOU formalizes the establishment of a new interagency task force, the Cancer Diagnostic Devices Interagency Task Force (CD2), which includes representatives from the NCI, FDA, HRSA, and the Centers for Medicare & Medicaid Services (CMS). It is anticipated that CMS leadership will also sign the MOU in the near future. CD2 aims to work with both public and private sectors to begin identifying gaps and opportunities in cancer diagnostics to accelerate innovation in biomedical science, particularly in the field of near-patient diagnostics. Near-patient diagnostics refers to a system whereby the sample is analyzed, and the results delivered all in the same location and at the same time that the patient is being evaluated.

The MOU was signed by the Director of the NCI, Dr. Norman E. Sharpless, MD; the Director of the Center for Devices and Radiological Health at the FDA, Dr. Jeffrey E. Shuren, MD, JD; the Director of the Oncology Center of Excellence at the FDA, Dr. Richard Pazdur, MD; and the Director of the Office of Planning, Analysis and Evaluation at HRSA, Dr. Susan Monarez, PhD. The Principal Deputy Director of the National Cancer Institute, Dr. Douglas R. Lowy, MD, also spoke during the virtual event, taking time to emphasize the importance of accelerating this area of cancer research.

The National Cancer Institute’s workshops on early detection and screening, held under leadership of Dr. Lowy, served as the impetus for the development of the task force. When asked about what sparked his initial interest in this effort, Dr. Lowy said “we have opportunities today that simply did not exist ten years ago, therefore it is a great time to capitalize on them. [This partnership] has the potential to help all patients live longer, healthier lives.”

In conversation with Dr. Lowy, NCI Director Dr. Sharpless spoke to the timeliness of this collaboration: “It is an interesting time [in cancer research] … There is a bewildering array of new technologies that have the potential for great utility, but how we bring these to patients--particularly those in underserved populations--is a pressing concern. We believe that, through these collaborations, we can accelerate the development of near-patient cancer diagnosis.”

When prompted to provide his thoughts on how this task force compliments the mission of the FDA’s Center for Devices and Radiological Health, Dr. Shuren had this to say: “This partnership reiterates the CDRH’s deep commitment to facilitating patient access to innovative, accurate, and reliable in vitro diagnostics for all Americans … Through this task force, we will be able to leverage each agency’s complementary capabilities and expertise to gain a deeper understanding of cancer disparities and formulate solutions to address them.”

Dr. Pazdur, Founding Director of the FDA’s Oncology Center of Excellence, shared his thoughts on the collaboration and how it synergizes with Oncology Center of Excellence’s goals: “This interagency Memorandum of Understanding has the potential to improve the lives of patients with cancer who are not typically the focus of oncology medical product development … Developing near-patient diagnostics to improve the lives of patients with cancer is a complex challenge that will benefit from the diverse expertise of the MOU partners.”

Before all parties signed the memorandum, Dr. Monarez, the Director of HRSA’s Office of Planning, Analysis and Evaluation, shared her thoughts on the benefits and potential outcomes of this partnership: “This Memorandum of Understanding strategically aligns with HRSA’s mission to improve health outcomes, and achieve health equity through access to quality services, a skilled health workforce, and innovative, high-value programs … This is transformational work that is absolutely needed as we look ahead to a more equitable future for all populations.”

All parties agreed that signing this MOU and the establishment of the CD2 Task Force serves to further bolster the exchange of ideas and information between these three agencies, a key step towards building bridges and fostering innovation in cancer diagnostic devices for near-patient use.