R43CA302117

Development and validation of patient-ready Callascope for cervical imaging - Cytology-based screening, diagnostic colposcopy and excisional treatment are proven solutions for cervical cancer prevention in high-income countries (HICs).

Affordable tools for screening, diagnosis, and treatment in low- and middle-income countries (LMICs) are either lacking or the few health facilities with access to them are frequently out of reach; resulting in low screening and follow-up rates.

Vaccination does not benefit the millions of women who already have the Human Papilloma Virus (HPV) or who will contract it before vaccination is widely available.

As a result, women present with advanced disease untreatable by currently available modalities, leading to over 300,000 deaths each year.

The number of expected deaths will continue to increase and is expected to double by 2050.

These facts are sobering - another generation of women will die at the prime of their lives, devastating their families and their children’s health.

We have developed a robust health care model to resolve the incongruity between highly effective biomedical engineering solutions and their uptake into care delivery systems for global cervical cancer prevention.

There are three facets to our model:

(1) Technology: A suite of point of care solutions to provide screening, diagnosis and treatment alternatives to those used in high-resource settings,

(2) Community-based health care: Community-based clinics in which screening, diagnosis and treatment are provided by community health workers and midwives,

and (3) Communication: A virtual hub to link community health workers, midwives and physicians to ensure seamless continuum of care.

The key attribute of our model is that it shifts care from hospitals and physicians to community health workers and midwives, dramatically increasing access to care.

We have observed that access continues to be a problem, one that is observed globally by implementers and program planners.

This is related to both population and health infrastructure barriers.

The inability of certain segments of the population to visit a clinic includes but is not limited to the lack of resources, geographic barriers that make it challenging to reach a clinic, and the trepidation of receiving the exam in an unfamiliar environment.

Barriers related to health resources include lack of sufficient health providers, limited medical supplies, and the unavailability of administrative support and medical record keeping.

There is a critical need for solutions to address uneven access to care.

Even when health care delivery is decentralized from hospitals to communities, therefore, we propose an innovative technology called the Callascope to transform provider-controlled speculum-based imaging in a clinic to a patient-controlled self-imaging procedure at home that affords privacy and autonomy of an otherwise intrusive exam.

Our long-term goal is to develop a fully functional Callascope that meets the requirements for triage of screen-positive populations (women who are HPV positive).

Given the low prevalence of disease, this will reduce unnecessary clinic visits by 20-fold (50 out of every 1000 women), thereby allowing for efficient use of limited resources for high-risk populations and alleviating the burden of follow-up care to those who are at low-risk.

Calla Health Foundation

TO IMPROVE SCREENING AND EARLY DETECTION STRATEGIES AND TO DEVELOP ACCURATE DIAGNOSTIC TECHNIQUES AND METHODS FOR PREDICTING THE COURSE OF DISEASE IN CANCER PATIENTS. SCREENING AND EARLY DETECTION RESEARCH INCLUDES DEVELOPMENT OF STRATEGIES TO DECREASE CANCER MORTALITY BY FINDING TUMORS EARLY WHEN THEY ARE MORE AMENABLE TO TREATMENT. DIAGNOSIS RESEARCH FOCUSES ON METHODS TO DETERMINE THE PRESENCE OF A SPECIFIC TYPE OF CANCER, TO PREDICT ITS COURSE AND RESPONSE TO THERAPY, BOTH A PARTICULAR THERAPY OR A CLASS OF AGENTS, AND TO MONITOR THE EFFECT OF THE THERAPY AND THE APPEARANCE OF DISEASE RECURRENCE. THESE METHODS INCLUDE DIAGNOSTIC IMAGING AND DIRECT ANALYSES OF SPECIMENS FROM TUMOR OR OTHER TISSUES. SUPPORT IS ALSO PROVIDED FOR ESTABLISHING AND MAINTAINING RESOURCES OF HUMAN TISSUE TO FACILITATE RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.394 - Cancer Detection and Diagnosis Research

National Cancer Institute (NCI) [HHS - NIH]

North Carolina United States

State-Wide

PHS 2024-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required) (PA-24-246)