Digital and computational pathology solution firm Proscia has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Concentriq AP-Dx. The digital pathology solution was cleared for the purpose of primary diagnosis.
Proscia’s Concentriq AP-Dx is a comprehensive diagnostic software solution that immerses pathologists in an intuitive experience for viewing, interpreting, and managing whole-slide images and helps to drive confidence and efficiency gains. It can also streamline collaboration, broadening access to expertise. Concentriq AP-Dx was designed to be used in clinical settings of all sizes, from individual reference laboratories to the largest hospital systems.
In support of its 510(k) clearance, Proscia conducted a multi-site clinical study at PathGroup, South Bend Medical Foundation, and Spectrum Healthcare Partners. The study demonstrated that diagnoses made on Concentriq AP-Dx are non-inferior to traditional glass slide reads. Relative to ground truth data, the difference in major discordance rates for slides read digitally and for slides read using the microscope was -0.1%, which is among the strongest findings of similar publicly available studies.
“This regulatory milestone reflects our tireless commitment to our mission of perfecting cancer diagnosis,” said David West, Proscia’s CEO. “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.”
In addition to its 510(k) clearance, Proscia was the first company to achieve CE-IVDR certification to advance primary diagnosis in the European Union. The company also has a product licensed in Canada and cleared in the United Kingdom among other countries. More than 10,000 pathologists and scientists, including those at top diagnostic laboratories and 14 of the top 20 pharmaceutical companies, trust Proscia’s software.
To learn more about Concentriq AP-Dx and see a live demo, register for Proscia’s webinar. Welcome to Concentriq AP-Dx will take place on Friday, March 8 at 5PM GMT.