Description:
Fast-Track Proposal will be accepted
Direct-to-Phase II proposal will be accepted
Number of Anticipated Awards: 4-6 (3 for HPV diagnostics)
Budget (total costs, per award):
Phase I: up $400,000 for 12 months
Phase II: up $2,000,000 for 2 years
PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.
Summary
Cancer is a leading cause of premature death in low-resource settings globally, where gaps in access to cancer prevention,
screening, early detection, and diagnosis present significant challenges.
For example, cervical cancer is the fourth most common cancer in women. When pre-cancer or early-stage cancer is
diagnosed, it is one of the most preventable or treatable forms of cancer, respectively. As a result of complex and expensive
cytology-based programs in high-income countries, cervical cancer has become a cancer that defines health disparity
populations and one that is still a major cause of morbidity and mortality in low-resource settings globally, where building
out a cytology-based screening program may not be realizable. Realization of that goal given the current commercially
available human papillomavirus (HPV) tests is unlikely without newer, lower-cost tests coming to market.
The purpose of this solicitation is to provide funding opportunities for small business concerns (SBCs) to develop cost
effective and affordable technologies for cancer prevention, early detection and/or diagnosis that target low-resource
settings, both internationally and within the US. It will allow applications to any specific cancer type, however four cancer
types (tissues) are of particularly interest because they are highly amenable to prevention, early detection, and diagnosis in
low-resource settings. The four cancer types of interest are: cancers of the cervix, colon/rectum, esophagus, and oral cavity.
These four cancer types are given a high priority because the introduction of affordable and cost-effective technologies for
cancer prevention early detection and diagnosis is likely to have an especially strong impact to reduce the burden of these
cancers in low-resource settings.
For cervical cancer, one of the goals for this initiative is to support the development of new alternatives to standard labbased HPV testing to the market that are both in a form factor as well as price point that will enable primary screening
paradigms based on self-collected cervicovaginal specimens to be established globally. Specifically, at- or near-patient
nucleic acid amplification approaches are needed that enable rapid detection and genotyping for HPV.
Project Goals
The goal of this solicitation is to encourages applications from SBCs to develop or adapt, apply, and validate existing or
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emerging technologies into low-resource setting-appropriate technologies for cancer prevention early detection and/or
diagnosis. Investigators must explicitly consider potential for adoption and scale-up in the local context as design criteria
for technologies proposed in applications responding to this solicitation.
Projects proposed for this contract topic will require multidisciplinary efforts to succeed, and, therefore, all applicant teams
must include expertise in oncology, engineering, global health, and healthcare delivery in low-resource settings. Products
addressing cancers of the cervix, colon/rectum, esophagus, and oral cavity are highly encouraged for this solicitation.
However, applications may address any single cancer type.
For cervical cancer, this solicitation is particularly focused on the development of rapid HPV diagnostics at the point-ofneed suitable for taking to scale (e.g., a portable loop-mediated isothermal amplification (LAMP) based assays).
Scientific/Technical Scope
Applications submitted to this solicitation must propose to develop or adapt technologies into user-friendly, affordable
products for prevention, early detection, and diagnosis of cancers in a low-resource setting.
The proposed project must focus on a specific cancer type (histology) and must show preliminary evidence to deliver
medical utility for improved cancer outcomes. Products addressing cancers of the cervix, colon/rectum, esophagus, and oral
cavity are particularly encouraged for this solicitation. However, applications may address any single cancer type.
The proposals must include quantitative milestones and a way to document the clinical utility of the propose product within
the specific low-resource healthcare system of interest. The proposed product must comply with the regulations and
international standards/guidelines applicable to investigational medical products in the low-resource setting where the
product will be used (examples are World Health Organization guidelines and local regulations in LMICs, and Good
Laboratory Practice, Good Manufacturing Practice, FDA Investigational New Drug, and Investigational Device Exemption
for US settings). All applicants should demonstrate familiarity with applicable regulatory requirements, while Phase II
applications require in the commercialization plan to include a detailed regulatory strategy matched to the low-resource
setting of the study.
Beyond the scope of this solicitation, it is anticipated (and encouraged) that the outcomes of successful SBIR projects will
help attract strategic partners or investors to support the ultimate commercialization of the technology as a publicly
available product or service.
Projects funded by this solicitation may include patient enrollment in foreign countries. Per SBIR policy, when there are
special circumstances justifying the conduct of the proposed research outside the US within time and budget constraints
(e.g. a high disease incidence that makes clinical validation more feasible and timely), agencies may approve performance
of a portion of the SBIR R&D work outside of the US. In this case, applicants are required to include a statement in their
applications on why these resources are not available in the US.
Technology areas of interest for cancer prevention, early detection and diagnosis include, but are not limited to, the
following:
• Delivery technologies to improve reliability, effectiveness, and/or safety of vaccines at the point of use (e.g.,
needle-free delivery methods, intradermal delivery, or oral delivery)
• Diagnostic microarrays
• High-throughput cancer screening, cytology, or imaging-based screening
• In vitro diagnostic assays such as point-of-care (POC) analytical tools for exfoliated epithelial specimens (e.g.,
cervical Pap specimens), blood, saliva, or urine (e.g. lab-on-a-chip biosensors that allow remote performance of
chemical and/or biological assays outside of a laboratory environment)
• Machine learning algorithms to identify precancer and cancer in optical images captured with simple devices
(e.g., smart phones)
• Portable imaging devices for cancer diagnosis (e.g., optical imaging, diffuse optical tomography, endoscopy, or
ultrasound)
• "pop-up" labs for cancer screening and diagnosis
• Smartphone-based technologies for cancer prevention, detection and/or diagnosis
• Software tools for cancer prevention, such as tools for screening, vaccine dissemination, or tools to improve
vaccine supply chains
• Tele-oncology (e.g., tele-diagnosis, tele-screening, tele-cytology, or tele-colonoscopy)
• Tests to predict the potential effectiveness of chemotherapy
• Tools for information and communications technologies to enhance cancer data collection, sharing, or analysis
Technologies that are generally not appropriate for this solicitation include the following:
• Companion diagnostics for high-cost drugs that are not affordable in low-resource settings
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• Devices that involve highly invasive interventions
• Devices that require extensive user training before they can be used (e.g., FDA definitions moderate and high
complexity devices)
• Experimental diagnosis modalities that are not approved in the US
• Technologies not affordable or cannot be maintained in lower-resource settings (e.g., World Bank definitions of
low-income and lower middle-income countries)
Expected Activities and Deliverables
Quantitative milestones are required for both Phase I and Phase II projects, regardless of whether they are combined in a
Fast-Track application.
It should be noted that low-resource settings have limited healthcare budgets and often struggle to prioritize healthcare
needs. Because of the variation in healthcare systems among LMICs and US regions with underserved populations,
applicants will need to consult with local partners and organizations (beginning before they submit their application) to
develop plans for product design and testing that are suitable to the low-resource setting, including strategies for regulatory
approval and reimbursement (if applicable) for the proposed product.
Examples of suitable consulting organizations are local hospitals, medical schools, charities, community groups, nongovernmental organizations, and local governmental offices with expertise in the setting. A portion of contract fund can go
to these organizations, standard SBIR outsourcing requirements apply.
Phase I Activities and Deliverables
• Develop a working prototype based on adaptation of existing technology, or development of new technology
• Demonstrate the feasibility of the technological innovation for use in a low-resource setting (real or modeled),
using a small number of biological samples or animals, where appropriate
• For software/IT tool development, applicants are required to conduct a pilot usability study with at least 25 users
• Deliver to NCI the SOPs of the system for cancer prevention, and/or diagnosis.
• Develop a regulatory strategy/plan and timeline for seeking approval from the appropriate regulatory agency to
market the product
• Provide a brief business plan, which is likely to require partnering with healthcare staff local to the low-resource
setting of interest
Specific activities and deliverables for applications focused on HPV diagnostics:
o Using end-user design principles, develop the prototype diagnostic device with the following characteristics:
Ease of use: the device must be suitable for use by local caregivers with minimal training in its operation
and maintenance
Operable in locations with limited clinical infrastructure (i.e., design for use outside of laboratory settings)
Designed for use at the community level and in non-traditional healthcare settings.
Intended for use with self-collected cervicovaginal specimens obtained with one of the current commercially
available kits
o Demonstrate a working relationship with the site(s) where the clinical validation study will take place.
o Conduct studies to establish analytical performance (analytical sensitivity, specificity) and other performance
characteristics (e.g., limit of detection, consistency, reproducibility) with self-collected samples.
o Conduct studies to evaluate and test user acceptability and feasibility in both average-risk and high-risk (e.g.,
women living with HIV) populations.
o Conduct initial cross-validation with at least one of the current FDA-approved HPV testing assays to determine
the clinical performance measures.
Phase II Activities and Deliverables
• Continue the consultation with local healthcare delivery experts in the low-resource setting of study
• Adapt the prototype device developed in Phase I to the targeted low-resource setting
• Validate the device in the low-resource setting(s) with a statistically significant number of animal and/or human
samples, live animals, or human subjects (if animal work or human subjects are involved) for the proposed
product. Animal studies are optional and may not be needed for many products supported by this solicitation.
Animal studies need only be proposed for products where intermediate testing in animals is thought to be
necessary for regulatory approval, or necessary before an IRB will approve a follow-on human study
• Validate the product with a large-scale validation/usability study with at least 100 users if a software/IT tool is
developed
• To the extent possible, benchmark the product against existing commercial products used to address the same
healthcare need in developed countries and include a description of competitive landscape in the
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commercialization plan
• Engage with local state regulatory agency to refine the regulatory strategy
• In the first year of the contract, provide the Program and Contract officers with a letter(s) of commercial interest.
• In the second year of the contract, provide the Program and Contract officers with a letter(s) of commercial
commitment, where appropriate
• By the end of Phase II, engage with the appropriate regulatory agency (e.g., US Food and Drug Administration,
World Health Organization) to seek and/or obtain marketing approval for the product that was developed.
Specific activities and deliverables for applications focused on HPV diagnostics:
o Develop a well-defined diagnostic device under good laboratory practices (GLP) and/or good manufacturing
practices (GMP)
o Perform manufacturing scale-up and production for multi-site and multi-test evaluations, including sites both in
the U.S. and at a site in a resource-limited setting
o Demonstrate the clinical sensitivity and specificity of the device for self-sampling by performing multi-site and
multi-test evaluations
o Develop a training plan for healthcare delivery users, to help assure progression toward clinical utility and
benefit from the validated technology.
o Report on the sustainability/durability of the device/assay
