Clearview Diagnostics Receives NIH Grant to Develop Portable Ultrasound for Breast Cancer Screening

PISCATAWAY, N.J., July 23, 2014 /PRNewswire/ -- Clearview Diagnostics, Inc. as part of a compendium, announced today the receipt of a grant from the NIH (National Institute of Health) to develop a portable self-reading device for breast cancer screening. Clearview will be working with the Dr. Susan Love Research Foundation to develop portable, self-reading ultrasound for breast screening. The focus of these development efforts and the directive with this grant is toward a low-cost portable device to triage palpable lumps and therefore narrow the breast cancer detection gap in developing countries and reduce stress on healthcare delivery systems. The grant, a two-year UH2 Phase 1 exploratory cooperative agreement, initially provides approximately $1mil. for Phase 1 and could potentially provide up to $4MM in total funding for Phase 1 and Phase 2.

Breast cancer is the leading cause of death from cancer and disability among women, especially young women, in low- and middle-income countries (LMIC). Survival rates in developing countries are less than half that of the United States mainly for lack of resources for diagnosis and treatment. In developing countries, breast cancer is most commonly found in women less than 50 years of age with a palpable lump. The goal for the UH2 grant period is to develop a low-cost, self-reading ultrasound device by employing imaging enhancing algorithms and computer-aided detection and diagnosis (CAD), to distinguish between malignant palpable lumps and clearly benign lumps, such as cysts, fibroadenomas, and fibrocystic change. The user-friendly device will not require highly trained professional staff to operate, making it accessible to a broader range of LMIC health care facilities, and enabling those already-stressed healthcare systems to focus resources on the women most likely to benefit from their efforts.

Proven pattern recognition technology, novel algorithms for ultrasound image enhancement, and computer-aided detection and diagnosis will be combined with real-time information generated by the live ultrasound scans to determine the probability of malignancy. A clinical validation trial will be performed at county hospitals in Southern California to determine the sensitivity and specificity of the ultrasound device. The NIH will then assess the feasibility for transitioning the project to a UH3 Phase II grant, which is usually the follow on support for those coming through UH2 grants showing good promise. This would include a clinical trial in Jalisco, Mexico to validate effectiveness, acceptability, and feasibility of the technology in a developing country.

The device development and clinical validations will be performed in close collaboration between breast cancer expert and surgeon Dr. Susan Love, and breast imaging radiologist and clinical trial expert Dr. Wendie Berg (University of Pittsburgh), medical software product development and commercialization expert Christine Podilchuk, PhD (ClearView Diagnostics), and technology and commercialization expert Professor Richard Mammone (ClearView Diagnostics/Rutgers University).  

Christine Podilchuk, Ph.D, Clearview's CEO said she is excited to add their expertise in ultrasound breast screening and imaging to the development efforts through this grant. "We are inspired by the need to eradicate breast cancer, and our primary focus is on innovative image processing technology to assist in early detection and accurate diagnosis of breast cancer to improve patient outcome and quality of life. "

Research reported in this press release is supported by the National Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health under Award Number UH2EB019889. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About ClearView Diagnostics

Founded by Professor Richard Mammone, Clearview Diagnostics, Inc. is located in Piscataway, NJ and is a Rutgers University tech start-up company. ​The company has received funding and advisory support from River Styx Capital, an RRBB Accountants and Advisors affiliate.  Larry Frankel of River Styx said, "Clearview is one of our most exciting projects, not only for the benefit it will have in breast cancer detection and cost reduction, but because of the speed with which the Clearview team delivered this transformative product." www.clearviewdiagnosticsinc.com

Clearview recently received FDA approval to market their imaging software system, ClearViewHD. The ClearView Image Enhancement System uses proprietary patent-pending technology to significantly enhance the ultrasound images used for breast cancer diagnosis. Ultrasound imaging is especially useful in women with dense breast tissue, found in up to 50% of the female population and especially prevalent in younger women, where traditional mammogram screening can fail to find the cancer.

About Dr. Susan Love Research Foundation

Dr. Susan Love Research Foundation is dedicated to achieving a future without breast cancer by engaging the public and the scientific communities in innovative research on cause and prevention. We do this through performing and facilitating innovative and collaborative research, translating science to engage the public as informed partners, and inspiring novel research.

Dr. Susan Love Research Foundation has received a 4-star Charity Navigator rating for three consecutive years, putting it in the top 12% of rated charities in terms of fiscal performance, accountability, and transparency. The Foundation is also a GuideStar Exchange Silver Level participant and a member of the Better Business Bureau Wise Giving Alliance.

Dr. Susan Love Research Foundation, and its more than 376,000 volunteers nationwide, invite you become part of a movement to engage the public in breast cancer research with the goal of eradicating the disease once and for all. To learn more and show your support, visit www.actwithlove.org.

SOURCE Clearview Diagnostics, Inc.