citybiz+ PreciseDx Uses AI to Predict Recurrence of Breast Cancer

New York-based PreciseDx, which recently closed a $20.7 million Series B, is poised to advance AI-based technology that can predict the risk of recurrence in breast cancer patients.

The physicians-founded startup has developed a tool called PreciseBreast, which uses a custom AI model to evaluate millions of data points in breast cancer patients. When paired with its proprietary morphology feature array technology, PreciseBreast can assess an early-stage breast cancer patient’s chances of facing a recurrence later in life. The tool delivers a so-called “recurrence score” that can also be used to complement existing markers such as HER2 — human epidermal growth factor receptor 2, whose excess is a marker for breast cancer.

Tool Gains Validation

An analytical validation study for PreciseBreast assessment, published last November in “Clinical Breast Cancer,” showed that the tool accurately predicts early-stage breast cancer risk of recurrence within six years.

“This accomplishment marks a crucial milestone in our ongoing mission to empower individuals and healthcare professionals with the latest advancements in breast cancer management,” said Precise Dx’s co-founder and chief medical officer Michael Donovan, Ph. D., MD. “The importance of these results is the demonstration of reliability for an assessment process that has the potential to improve accessibility and standardization to breast cancer patients around the globe and ultimately elevate the standard of care for patients,” he added.

UCLA Collaboration

Last year, PreciseDx announced a collaboration with UCLA’s Department of Pathology and Laboratory Medicine to assess the tool’s ability to predict recurrence risks in patients diagnosed with triple-negative breast cancer — a particularly aggressive version that accounts for up to 20% of all breast cancer cases. It is often linked to younger women, BRCA1/2 gene mutations and ethnic/racial disparities.

PreciseBreast claims several advantages, including greater accuracy, lower costs and faster results that can be delivered in 48 hours. It also meets the rigorous Clinical Laboratory Improvement Amendments, or CLIA, standards and has passed the Clinical Laboratory Evaluation Program, or CLEP, assay validation review by the New York State Department of Health, the company said. The company said it plans to use the latest funding round to expand commercialization efforts for PreciseBreast.

Team Behind PreciseDx

PreciseDx was founded in 2019 by the foursome of Donovan and three other physicians —Carlos Cordon-Cardo, who chairs the company’s advisory board, chief scientific officer Gerardo Fernandez and Jack Zeineh, who serves as chief technology officer.

Cordon-Cardo serves as professor and chair system-wide of the Department of Pathology, Molecular and Cell-Based Medicine at the Icahn School of Medicine at Mount Sinai Health System. He has previously been a faculty member in the Department of Pathology at Memorial Sloan-Kettering Cancer Center.

Donovan is vice chair and professor of Translational Research in the Department of Pathology at the University of Miami. Besides an academic career at Harvard Medical School and Boston Children’s Hospital, Donovan has decades of experience in the biotechnology industry, having held senior management roles at Millennium Pharmaceuticals and Incyte Pharmaceuticals.

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Zeineh has previously held technology leadership positions at Clarient, Carl Zeiss Microimaging AIS and Aureon Biosciences, besides being the co-founder of Trestle Corporation. He graduated Summa Cum Laude from the University of California at Irvine in Biological Sciences, and received his medical degree from the University of California at San Diego.

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Fernandez is adjunct associate professor in the Department of Pathology, Molecular and Cell-Based Medicine at the Icahn School of Medicine at the Mount Sinai Health System. He received his medical degree from Drexel University College of Medicine and completed his residency in anatomic and clinical pathology as well as fellowships in surgical pathology and cytopathology from New York University School of Medicine.

PreciseDx is led by CEO Eric Converse, who most recently led AMRA Medical AB, a Software-as-a-Medical Device (SaMD) company funded by Pfizer Ventures and Novo Holdings, among others. He has also served as an independent consultant for Merck’s Global Health Innovation Fund.