Philadelphia software company receives clearance for diagnostic tool

The U.S. Food and Drug Administration (FDA) recently gave Philadelphia-based Proscia, a software company, clearance for its Concentriq AP-Dx digital pathology solution.

“This regulatory milestone reflects our tireless commitment to our mission of perfecting cancer diagnosis,” Proscia CEO David West said. “Pathologists are facing more pressure than ever before in the fight against some of humanity’s biggest challenges. With 510(k) clearance, we can help more laboratories improve the pathologist experience and better serve their patients.”

Concentriq AP-Dx was designed to be used in clinical settings and allows pathologists to view, interpret, and manage whole slide images.

The company conducted a multi-site clinical study that demonstrated that diagnoses made on Concentriq AP-Dx are non-inferior to traditional glass slide reads.

Pathology is used in up to 70 percent of clinical decisions. Digital pathology uses high-resolution images each containing over 1 billion pixels instead of a standard microscope to diagnosis diseases.

The number of new cancer cases in the United States is expected to surpass 2 million annually this year. Laboratories are hiring pathologists at a record rate.

The European Union also recently gave Proscia CE-IVDR certification to advance primary diagnosis. The company also has been cleared in the United Kingdom and has a product licensed in Canada.