FDA Grants Breakthrough Designation to 4D Path for Novel Cancer Diagnostic Solution


Potential for a New Standard of Care to Improve Diagnostic Accuracy for Breast Cancer Exclusively from H&E Biopsy/Resection Images

Newton, Massachusetts, November 18, 2020 – 4D Path, creator of a patented computer-aided cancer diagnostic and precision oncology platform, today announced that the U.S. Food & Drug Administration (FDA) has granted the company Breakthrough Device Designation for its first software-as-a-medical-device solution. The 4D Q-plasia OncoReader Breast provides histopathologists with an adjunct technology to improve diagnostic accuracy of breast cancer features (e.g., its invasiveness, grades, etc.) solely from digitized histopathology images obtained via biopsies or resections, demonstrating promise of significant improvements over the existing standard of care.

“4D Q-Plasia OncoReader Breast is the first-of-a-kind fully automated ‘breakthrough device’ that can perform clinical grade predictions from H&E stained breast biopsy and resection images without any pre-annotation or any human intervention,” said Tathagata Dasgupta, PhD, founder and CKO/CTO at 4D Path. “The device shows great promise in aiding clinical histopathologists to mitigate some of the diagnostic challenges in the current standard of care, particularly those stemming from tumor heterogeneity, thereby improving the diagnostic accuracy.”

The FDA’s Breakthrough Device Program was established to accelerate the availability of transformative medical devices to patients and healthcare providers by speeding up their development, assessment and review, while preserving the statutory standards for premarket review and authorization. Awards are strictly restricted to innovative devices that provide more effective diagnosis or treatment of life-threatening conditions (e.g., cancer) and that offer significant advantages over the existing standard of care, where no approved or cleared alternatives exist, and where early device availability is in patients’ best interests.

Breast cancer remains a significant clinical problem, with one in eight women being affected in their lifetime. Improving diagnostic accuracy at the level of biopsies is becoming increasingly important, especially considering changes in surgical and oncological practice. 4D Path’s technology could be invaluable for improving access to histopathology services where these may not be readily accessible and affordable to everyone.

“We are thrilled that the FDA has recognized the potential of our technology to offer significant advantages over existing approved or cleared alternatives to establish long-term clinical efficiencies. Our device acts on par with a diagnostic histopathologist in the identification of invasive cancer," said Dr Nic Orsi, PhD, chief pathologist for 4D Path. "However, when it comes to making an accurate diagnosis of grade – that's a measure of how abnormal tumor cells appear and how aggressively a tumor will behave – 4D Path's device reduces the error rate on biopsies obtained before surgery from 20% to less than 5%. This is important for patients who have less invasive treatment; where diagnostic tissue is limited; or for those who receive chemotherapy before surgery, where tumor appearance is altered by the treatment.”

Professor Andrew Hanby, NHS Consultant Breast Histopathologist at Leeds Teaching Hospitals Trust, which has a long-standing working partnership with 4D Path adds, “Unlike current rival AI methodologies, 4D Path’s technology significantly augments and revolutionizes the goal of achieving high levels of accuracy in diagnostics. It promises to enhance both the quality and efficacy of the process, giving patients the assurance that their treatment pathway has a solid and safe foundation."

“The key ability of our platform is to extract tumor microenvironment dynamics from static H&E tissue morphological data and map it to distortions in underlying biological pathways and checkpoint perturbations. The identification of these pan cancer digital biomarkers draws heavily on statistical physics and tumor biology,” said Satabhisa Mukhopadhyay, PhD, founder and chief scientist at 4D Path. “This is totally new in digital pathology, where other AI-based diagnostic algorithms have been limited to learning morphology-based cell type identification and classification. This makes them inherently vulnerable to patient-to-patient variability. We tackle this problem from an entirely novel perspective by unveiling hidden data in H&E images that enables us to determine both clinical diagnosis and tumor molecular profile in a single step.”

The potential advances and benefits offered by this technology have been welcomed by patient advocacy groups. The Cancer-specific Patient and Public Involvement (PPI) Group in Leeds, having reviewed the development of the 4D Q-plasia OncoReader Breast, states: “By accelerating the process and overcoming supplementary testing, both diagnostic costs and turnaround times would be significantly decreased, thereby reducing the financial burden on patients and healthcare providers. These developments are timely given the recognized shortage of diagnostic histopathologists nationally and globally, coupled with the ever-growing demand for diagnostic services.”

The breakthrough designation will entitle 4D Path to an expedited and priority regulatory process. Founded in 2016 and previously in stealth mode, the company has already achieved significant milestones including the approval (a First Action Allowance) of its first utility patent application earlier this year.

About 4D Path
Just because you can’t see something, doesn’t mean it’s not there. 4D Path’s patented precision oncology platform is designed to unveil previously hidden data to instantly provide biomarker profiling and stratification directly from H&E whole slide biopsy/resection images only. 4D Path’s cloud-based, quantitative approach is intended to eliminate the need for additional molecular tests (e.g., immunohistochemistry, FISH, RNA-Seq, NGS), accelerating complete, actionable and objective insight leading to expedited and democratized precision medicine. 4D Path’s quantitative approach is designed to provide clinical solutions in both companion diagnostics and translational medicine without compromising the current standard of care to reduce the cost, time and complexity of patient care and management, and clinical trials. Its patented methods and integrated platform combine universal physics, biology and mathematical principles to identify tumor-specific phenotypic and genotypic fingerprints in order to inform treatment selection and stratify patients accordingly. Visit www.4DPath.com to learn more.

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