4D Path has secured the US Food and Drug Administration (FDA) Breakthrough Device Designation for Q-plasia OncoReader Breast, its first software-as-a-medical-device solution.

The new 4D Q-plasia OncoReader Breast offers an adjunct technology for improved accuracy in breast cancer diagnosis, with digitised histopathology images from biopsies or resections.

4D Path founder and CKO/CTO Tathagata Dasgupta said: “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.

“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.”

According to the company, breast cancer is a clinical condition affecting one in eight women, and improved diagnostic accuracy at biopsies is crucial, given the changes in surgical and oncological practice.

4D Path said that its technology aims to improve access to histopathology services which are not readily accessible and affordable to all.

The breakthrough designation granted by the US FDA is expected to enable 4D Path to enter into an expedited and priority regulatory process.

Established in 2016, the company is engaged in providing its patented precision oncology platform.

4D Path chief pathologist Nic Orsi said: “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.

“However, when it comes to making an accurate diagnosis of grade – that’s a measure of how abnormal tumour cells appear and how aggressively a tumour 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.”