Team: Alan Harris (NYU Langone Health), Ellis Malovany, Robert Puskas, Steve Bolland
About the Venture: Definitive Diagnostics is developing affordable, highly accurate, and reliable blood tests that can detect newly discovered cancer-specific biomarker patterns in multiple cancers, initially focused on the millions of breast cancer patients each year, who, following a (false) positive mammogram, undergo additional, costly, painful, potentially wasteful testing, and delays in treatment.
First Target: The $8 Billion Waste in Breast Cancer
In the U.S., nearly 40 million women over age 40 undergo mammograms to screen for breast cancer every two years. Roughly 10% of the results are positive. But did you know that 95% of the positive results are false-positive?
To eliminate doubt physicians often order invasive needle biopsies to diagnose or rule out cancer. However, nearly eight out of ten breast biopsies are negative. The result? Millions of women each year receive painful biopsies and additional testing that can cost up to $6,000 per patient only to find out that their original mammogram results were wrong!
$8 billion is spent on biopsies and additional testing in the U.S. each year!
Driving Discovery & Innovation
To solve this and many other unmet diagnostics needs, Definitive Diagnostics is developing highly accurate blood tests to reduce false test results by 90%. The patented method analyzes a small amount of blood and measures a distinct set of protein biomarkers along with structural changes that activate a person’s immune responses.
This process generates distinct cancer patterns that in early lab testing on 273 patients, yielded 99% Sensitivity and nearly 97% Specificity, including at Stage I for breast cancer (with similar results in lung, colorectal, ovarian, and pancreatic cancers). If “Definitive” tests were currently available, they would be industry-leading!
The company has assembled an experienced management and advisory team composed of industry leaders and KOLs in biochemistry, oncology, regulatory, legal, and laboratory test development. Its collaboration partners will include Hamilton Corp, Thermo-Fisher Scientific, the prestigious Washington University Medical School Core Laboratories, and the world-renowned University of Kansas Medical Center’s Department of Science and Biostatistics.
What’s Next?
As the Company advances, it plans to add additional patient blood samples to its protein library, automate, and scale the technology on high-speed equipment (similar to LabCorp, Quest, or Mayo Clinic) to support millions of blood tests per year. Because proteins are easier to identify and less expensive to process than DNA, costs are a fraction of available DNA-based tests, providing a cost advantage over its competitors.
As the technology is automated, the Company will complete a series of algorithms and build an AI/ML interface to continuously refine cancer patterns as more data is gathered. With advanced AI analysis of protein biomarker activity, Definitive Diagnostics hopes to discover new patterns for even greater accuracy, initially in breast cancer, and then for other cancers and their subtypes.
Vision for the Future
Scaled, this technology could change forever the way breast cancer detection is done. Imagine a world in which affordable and accurate blood tests reduce the time to diagnosis, to accelerate life-saving treatment for people with cancer while dramatically eliminating wasteful and barbaric testing for those without.
Beyond the U.S., the test could be the low-cost solution that is desperately needed, especially in underserved markets and populations as a first line of screening where expensive mammograms and other testing equipment aren’t available or accessible. As the number of breast cancer cases is increasing at younger ages, the demand for simple and affordable testing solutions will continue to soar.
Conservatively, the Company sees a potential $2 billion revenue market in the U.S. breast cancer market, with global potential far exceeding that especially with dual applications in both confirmatory and screening tests. Beyond breast cancer, Definitive Diagnostics’ high accuracy in lung, colorectal, ovarian, and pancreatic cancers positions the company with a strong future pipeline in a combined TAM exceeding $16 billion.
A Last Thought…
While we all continue to hope that cancer will be cured, until there’s a preventative treatment or vaccine, diagnostics will continue to be the first line of defense in saving lives. We believe it should be accurate, affordable, and available…for everyone!
This is the “Definitive” vision.
