Key Dates

Related Announcements

NOT-CA-24-067 - Request for Information (RFI): Seeking Input on Existing Study Populations with Germline Results and Samples Available for Multi-Cancer Detection (MCD) Assay Testing

NOT-CA-24-051 - Request for Information (RFI): Seeking Input on Existing Study Populations with Germline Results and Samples Available for Multi-Cancer Detection (MCD) Assay Testing

NOT-CA-24-046 - Request for Information (RFI): Seeking Input on Existing Study Populations with Multi-Cancer Detection (MCD) Test Results and Available Samples for Germline Testing.

NOT-CA-22-010 - Request for Information: Seeking Input from Cohort and Biorepository Researchers on Liquid Biopsy Studies for Early Cancer Detection

NOT-CA-22-033 - Request for Information (RFI): Seeking Input from Multi-Cancer Early Detection Test Developers on Readiness for Participation in an NCI-Sponsored Clinical Utility Randomized Controlled Screening Trial

Issued by

National Cancer Institute (NCI)

Purpose

Purpose

This Request for Information is to solicit input about technologies which may be used for liquid biopsy studies of early cancer detection and assess interest in participating in a collaborative workshop on evaluation of cancer early detection biomarkers.

Background

Established screening recommendations exist only for several common cancers in the United States (e.g., breast, colorectal, cervix). Detecting cancers earlier may improve patient outcomes and reduce cancer-related mortality. However, most malignancies lack recommended screening programs. These cancers account for a majority of new cancer cases and cancer related screening deaths and tend to be diagnosed at later stages with a worse prognosis. Moreover, even for those cancers with screening recommendations, the uptake of screening is not optimal, especially in underserved populations. As a result, there has been much interest in developing non-invasive screening biomarkers that can be measured in a blood sample or other easily obtained biospecimen.

Liquid biopsy is being explored as a potential method to facilitate the early detection of cancer. Liquid biopsy generally refers to detecting circulating tumor cells (CTC), circulating tumor DNA (ctDNA), circulating exosomes and other analytes in body fluids, such as serum, plasma, urine, etc. Levels of ctDNA and different ctDNA biomarkers have been associated with more advanced disease and worse prognosis. In addition, some liquid biopsy technologies may be used to help guide selection of targeted therapies. Since the levels of these biomarkers tend to be lower in individuals at early cancer stages or prior to cancer symptoms, examining the use of these markers for early detection has been challenging. Newer technologies have improved limits of detection and the ability to detect multiple analytes from the same sample. Another challenge for liquid biopsy studies for early detection is that any individual cancer type is rare in a screening population. One strategy being explored is developing liquid biopsies for detecting multiple cancer types, or multi-cancer early detection (MCED) tests. Some results with these tests have been promising.

Before these assays can be used for cancer screening, they must be evaluated to demonstrate that these assays work in the biomarker screening pipeline including determining how well the assay distinguishes persons with clinical cancer diagnosis compared with no cancer (diagnostic performance study); how well the assays predict the development of clinical cancer among asymptomatic individuals (prediagnostic performance study); followed by a cancer screening trial. While several liquid biopsy technologies have been examined for distinguishing individuals with cancer, fewer studies have examined the prediagnostic performance in asymptomatic individuals who may be targets for cancer screening. The most efficient way to accomplish these studies is to use stored samples that are collected prior to cancer diagnosis. To advance this field, partnerships need to be encouraged between technology developers and population-based researchers (including cohort and biorepository researchers), to facilitate these biomarker investigations in the appropriate populations with the optimal study design.

Information Requested

The NIH seeks comments on any or all of these topics listed below. If information is available on a website or publication, please provide appropriate links.

• Description of technology and biospecimen requirements (e.g., type of specimen, specimen volume, specimen handling requirements) for liquid biopsy biomarkers of early detection.
• Describe assay detection limits
• Stage of biomarker development for the assay
• Describe assay performance capabilities in specimens collected in different tube types (e.g., PAXgene ccfDNA, STRECK cell-free DNA, EDTA, etc.)
• Cancers detectable with the biomarker
• Information regarding validation studies performed for liquid biopsy biomarker and study design sed for validation
• Most recent publication(s) providing description of the assay/technology
• Interest in participating in a collaborative workshop to support collaborations for evaluation of cancer early detection biomarkers

How to submit

Responses to this RFI must be submitted electronically to [email protected]

Responses must be received by 11:59 p.m. on January 15, 2022.

Responses to this RFI are voluntary. Do not include any proprietary, classified, confidential, trade secret, or sensitive information in your response. The responses will be reviewed by NIH staff, and individual feedback will not be provided to any responder. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public NIH websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements.

This RFI is for information and planning purposes only and shall not be construed as a solicitation, grant, or cooperative agreement, or as an obligation on the part of the Federal Government, the NIH, or individual NIH Institutes and Centers to provide support for any ideas identified in response to it. The Government will not pay for the preparation of any information submitted or for the Government’s use of such information. No basis for claims against the U.S. Government shall arise as a result of a response to this request for information or from the Government’s use of such information.

NIH looks forward to your input and we hope that you will share this RFI document with your colleagues.

Inquiries

Please direct all inquiries to:

Sudhir Srivastava, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-7028
Email: [email protected]

Matthew Young, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5846
Email: [email protected]

Leah E. Mechanic, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-6847
Email: [email protected]