Request for Information (RFI): Development of Assays/In Vitro Devices for Use in Clinical Oncology

Notice Number: NOT-CA-07-019

Key Dates
Release Date: June 13, 2007
Submission of Information: until July 25, 2007

Issued by
The National Cancer Institute (NCI) (

This Notice is a time-sensitive Request for Information (RFI) on the needs and bottlenecks in the development of assays and diagnostic devices in the in vitro setting (i.e., in the laboratory) and their translations to successful uses in the clinical oncology setting (i.e., in clinical management of patients with cancer).  This information will be used by staff members in the Cancer Diagnosis Program (CDP), Division of Cancer Treatment and Diagnosis (DCTD), NCI, to plan a program to facilitate the development and clinical use of such assays and diagnostic devices  For more information on the scope of CDP activities, please visit the CDP Web site at

This RFI is for planning purposes only and should not be construed as a solicitation for applications or proposals and/or as an obligation in any way on the part of the United States (U.S.) Federal government.  The Federal government will not pay for the preparation of any information submitted and/or for the government's use of that information. All submitted information shall remain with the Federal government and will not be returned.


A significant barrier to the use of biomarkers to aid clinical decisions is the lack of robust, reproducible, and clinically validated assays and in vitro devices.  CDP seeks to develop a program to facilitate the maturation of these assays/in vitro devices so that they can be assessed in clinical trials and moved more efficiently into clinical practice.  The assays and in vitro devices of interest include, but are not limited to: markers and their assays for the classification of tumors; assessment of prognosis; and prediction of response to drugs in cancer patients.

The mission of the CDP is to stimulate and support diagnostics research to aid in patient management decisions, including the choices of treatments for cancer patients and assessments of patients’ responses to therapies.  This program stimulates, coordinates, and funds, on an international basis, the development of resources and research focused on development and evaluation of diagnostics and improved technologies to better characterize cancers.  The ultimate goal of the supported research is the integration of assays and in vitro devices into clinical practice (i.e., to validate and integrate their uses in the clinical setting so that both patients with cancer and their physicians can obtain more accurate [sensitive and specific] diagnoses and choose more efficacious treatments).  The CDP currently facilitates the development of cancer diagnostics by supporting collections of tissue specimens and the development of technologies and trial designs for assessment of molecular markers.

This RFI is intended to inform the design of an initiative to improve the development of clinical laboratory assays.  Information is sought from investigators, working in non-profit academic and non-academic institutions, in clinical laboratories and at companies, who are developing assays and in vitro devices for clinical cancer applications.  To better understand the types of assistance that might be helpful for the development of devices like yours, please address the following areas in providing information in response to this RFI (you need not address all of the items listed below):

1) Background information regarding the specific purpose(s) and details of your assay or in vitro device as well as problems encountered during its development, such as:

- The type(s) of clinical decision(s) the assay or device is (are) designed to inform;
- The patient population(s) that is (are) targeted for the potential application(s) of the assay or device;
- The type(s) of molecular species that the assay or device is designed to measure (e.g., RNA, DNA, protein, other);
- The ability of the assay or device to measure single and/or multiple markers;
- The type(s) of technology (technologies) that the assay or device uses (use) (e.g., ELISA, IHC, ISH, microarray, other);
- The type(s) of technology platform(s) used when the assay is multiplex;
- Any other important contextual details re: how the assay or device is to be used;
- The stage(s) of development that the assay or device has attained with level of evidence supported by preliminary data (e.g., publications); and
- Any specific challenge(s) and/or barrier(s) that has (have) been encountered to date.

2) Desirable types of assistance to accelerate/facilitate assay/device development.

- For example, for technical expertise, describe:
                                --methods and/or conditions for assay optimization;
                                -- methods and/or conditions for reagent preparation;
                                -- methods and/or conditions for platform modification;
                                -- requirements for and/or approaches to uniform treatment of human subjects as donors of biological specimens;
                                -- methods of clinical annotation for fluids and tissues from human subjects; and/or
                                -- anything else appropriate.
                           - Statistical expertise
                           - Study design expertise
                           - Clinical expertise
                           - Other

Services and/or resources that you feel are most critical, i.e., that would allow you to proceed more efficiently to and through successful development.

4) The route/formal steps by which you intend to bring your assay into clinical practice.

Other comments relevant to this RFI and addressing issues that are not specifically mentioned above are also encouraged.

How to Submit a Response:

To facilitate responses to this RFI, a special response form is provided at

Responses using this form will be accepted via e-mail until July 25, 2007.

All information provided will be processed and analyzed with strict anonymity.


Inquiries concerning the Notice may be directed to:

James W. Jacobson, Ph.D.
Cancer Diagnosis Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
National Institutes of Health
6130 Executive Boulevard, EPN Room 6035A, MSC XXXX
Bethesda, MD 20892-XXXX (for U.S. Postal Service express or regular mail)
Rockville, Maryland 20852 (for non-USPS express/courier delivery)
Telephone: 301-402-4185

J. Milburn Jessup, M.D.
Cancer Diagnosis Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
National Institutes of Health
6130 Executive Boulevard,  EPN Room 6040, MSC XXXX
Bethesda, MD 20892-XXXX (for U.S. Postal Service express or regular mail)
Rockville, Maryland 20852 (for non-USPS express/courier delivery)
Telephone: 301-435-9010

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