A Solicitation of the National Institutes of Health (NIH) and The Centers for Disease Control and Prevention (CDC) for Small Business Innovation Research (SBIR) Contract Proposals

Active
No
Status
Closed
Release Date
August 25th, 2023
Open Date
August 25th, 2023
Due Date(s)
November 14th, 2023
Close Date
November 14th, 2023
Topic No.
NIH/NCI 458

Topic

Microbiome-Based Tests for Cancer Research, Diagnosis, Prognosis and/or Patient Management

Agency

Department of Health and Human ServicesNational Institutes of Health

Program

Type: SBIRPhase: BOTHYear: 2023

Summary

The Department of Health and Human Services, specifically the National Institutes of Health (NIH) and The Centers for Disease Control and Prevention (CDC), are seeking proposals for Small Business Innovation Research (SBIR) contracts. The solicitation, titled "Microbiome-Based Tests for Cancer Research, Diagnosis, Prognosis and/or Patient Management," focuses on the development of microbiome-based technologies for cancer research and patient management. The goal is to improve early and accurate diagnosis, prognosis, treatment assignment, and efficacy monitoring for various types of cancer. The solicitation emphasizes the need for technologies that address the limitations of current diagnostic tests, such as high false positive rates and low sensitivity. The proposed technologies should ideally use liquid biopsies, which are safer, more cost-effective, and faster to obtain than solid biopsies. The development of microbial signatures from cancer patient samples, in combination with other biomarkers, offers an exciting opportunity to develop new tools for better cancer diagnosis, prognosis, and patient management. The solicitation anticipates awarding 4-6 contracts, with a budget of up to $400,000 for Phase I projects lasting up to 12 months, and up to $2,000,000 for Phase II projects lasting up to 2 years. Proposals that exceed the specified budget or project duration may not be funded. The solicitation is closed, with a release date of August 25, 2023, and a closing date of November 14, 2023. More information can be found on the grants.gov website.

Description

Fast-Track proposals will NOT be accepted. Direct-to-Phase II proposals will NOT be accepted. Number of anticipated awards: 4-6 Budget (total costs, per award): Phase I: up to $400,000 for up to 12 months Phase II: up to $2,000,000 for up to 2 years PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED. Summary This proposal is for the development of microbiome-based technologies for cancer research, diagnosis, and patient management (e.g., prognosis, treatment assignment, and efficacy monitoring). Although early and accurate diagnosis is key to successful treatment, effective methods for early detection do not exist for many cancers. Indeed, the available diagnostic tests are characterized by either high false positive rates due to low specificity resulting in unnecessary surgeries for diagnostic confirmation (e.g., CT scan for lung cancers) and/or high false negative rates due to low sensitivity (e.g., CA125 and trans-vaginal ultrasound for ovarian cancers). For example, the sole FDA-approved biomarker for pancreatic cancer, serum CA19-9, is mostly used for disease monitoring rather than screening due to inherent limits in specificity as its levels can be elevated in several other concomitant conditions. Other types of diagnostics using liquid biopsies can detect cell-freecirculating DNA (ctDNA) derived from tumors in late-stage cancers (stages III and IV), as traditional ctDNA-based analyses lack the sensitivity required to detect small tumors/early lesions. Furthermore, accurate technologies are also needed for cancer prognosis, treatment assignment, and efficacy monitoring. In addition to addressing the specificity/sensitivity issues of the currently available approaches, microbiome-based technologies would ideally be capable of using liquid biopsies that are safer, more cost-effective, and faster to obtain than solid biopsies for a wider adoption in clinics. Recently, the microbiome was added to the list of cancer hallmarks and multiple clinical and preclinical studies have revealed an association of specific microbiome signatures with individual cancers and with response to therapy (chemotherapy, immunotherapy, and radiotherapy). In addition, recent advances integrating the analysis of large datasets from nextgeneration DNA sequencing, and new methods of computational modeling using AI and machine learning, have shown the feasibility of using microbial biomarkers for early cancer detection, and personalized medicine. Thus, the development of microbial signatures from cancer patient samples, ideally from liquid biopsies, to be used alone or in combination with other biomarkers, offers an exciting opportunity to develop new and innovative tools for better cancer diagnosis, prognosis, and patient management. These technologies using microbial signatures as biomarkers for cancer detection and patient management will also enable researchers to better understand the fundamental underlying biology and molecular dynamics of microbe-tumor interactions as the causes and roles of microbial changes associated with cancer are not well understood.