Big win for Paige Prostate as FDA grants approval for use in digital pathology

USA- The FDA has approved the sale of software, Paige Prostate, designed to assist pathologists in the detection of prostate cancer.

Paige prostate is the first artificial intelligence (AI)-based pathology product to be approved by the FDA, and it is used in conjunction with the company’s previously approved FullFocus digital pathology viewer designed to identify areas on a prostate biopsy that are most likely to be cancerous.

The FDA granted approval based on the results of a study in which 6 pathologists examined 527 digitally scanned prostate biopsy slides. There were 171 cancerous cells and 356 benign cells among them. The pathologist conducted two assessments, one with and one without the assistance of the software.

Paige Prostate improved cancer detection on individual slide images by 7.3%, with no effect on readings of benign slide images.

Pathologists examine biopsies of tissue suspected for diseases, such as prostate cancer, every day. Identifying areas of concern on the biopsy image can help pathologists make a diagnosis that informs the appropriate treatment,” Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in an agency-issued press release.

Risks of prostate cancer

Prostate cancer is the second most common cancer in men and the fourth most common cancer in general. In 2018, there were 1.3 million new cases.

According to the American Cancer Society, about 1 man in 8 will be diagnosed with prostate cancer during his lifetime. It estimates there will be nearly 250,000 new cases of prostate cancer this year.

It further highlights that prostate cancer is more common in older men and non-Hispanic Black men. About 6 out of every 10 cases are diagnosed in men 65 and older, and it is uncommon in men under 40. Men are diagnosed at an average age of 66.

According to the American Cancer Society, this type of cancer kills one out of every 41 men, making it the second leading cause of cancer death in American men, trailing only lung cancer.

Additionally, it is approximated that 34,000 people will die from prostate cancer this year.

However, thanks to advancements in screening and treatment, prostate cancer survival rates are improving. According to the American Cancer Society, the five-year relative survival rate of prostate cancer is 90%, with some variance depending on the stage.

According to an FDA official, Paige’s software has the potential to improve prostate cancer diagnostics, which in turn can improve patient outcomes.

This landmark approval of Paige Prostate portends a brighter outlook on prostate cancer treatment as the AI-based software can help increase the number of identified prostate biopsy samples with cancerous tissue, ultimately saving lives.

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