Proscia Receives FDA 510(k) Clearance For Concentriq AP-Dx

Key regulatory milestone advances company’s mission to perfect cancer diagnosis.

PHILADELPHIA – February 12, 2024 Proscia®, a leading provider of digital and computational pathology solutions, has received 510(k) clearance from the United States (U.S.) 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.”

Up to 70% of clinical decisions depend on pathology.[1] Digital pathology shifts the standard from microscope to high-resolution images each containing over 1 billion pixels that tell the story of a patient’s disease and hold the keys to advancing precision medicine. It is also driving powerful efficiency gains that help laboratories to overcome systemic challenges; hiring for pathologists is near an all-time high[2] as the number of new cancer cases per year in the U.S. is expected to cross 2 million in 2024 for the first time ever[3].

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 12PM EST.

*Concentriq AP-Dx is cleared (K230839) for clinical use with the Hamamatsu NanoZoomer S360MD Slide scanner in the United States.

 

About Proscia

Proscia is a software company accelerating the transformation to digital pathology to change the way we understand diseases like cancer. Its Concentriq enterprise pathology platform and powerful AI applications are advancing the 150-year-old standard of research and diagnosis towards a data-driven discipline, unlocking new insights that accelerate R&D, improve patient outcomes, and fulfill the promise of precision medicine. Leading diagnostic laboratories and 14 of the top 20 pharmaceutical companies rely on Proscia’s software each day. For more information, visit proscia.com.


[1] NHS England (2017). Digital First: Clinical Transformation Through Pathology Innovation. National Pathology Programme; doi: https://www.england.nhs.uk/wp-content/uploads/2014/02/pathol-dig-first.pdf

[2] Klipp, J. (2023). Pathologist Job Openings Remain Near Record High. Laboratory Economics, October 2023. 18(10) p. 10.

[3] Collins, S. (2024, January 17). 2024 – First Year The US Expects More than 2M New Cases Of Cancer. The American Cancer Society. Retrieved January 26, 2024, from: https://www.cancer.org/research/acs-research-news/facts-and-figures-2024.html

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