Proscia’s Concentriq® Dx Receives CE Mark for Primary Diagnosis
CE Mark enables Proscia’s entry into international anatomic pathology market
Philadelphia – November 6, 2019 – Proscia, a leading provider of digital pathology software, has received a CE Mark for its Concentriq Dx solution for use in primary diagnosis. With this certification, Proscia accelerates its entry into the diagnostic pathology market in Europe and other key geographies globally to help laboratories keep pace with the rising cancer burden.
The CE Mark indicates that Concentriq Dx complies with the European In Vitro Diagnostic Regulations. “This underscores Proscia’s commitment to providing high-quality solutions to meet the needs of pathology laboratories and cancer patients in the EU and affiliated countries,” said Natalia Remmel, Proscia’s Director of Quality and Regulatory Affairs.
“Europe is plagued by a chronic shortage of pathologists,” explained Steve Holloway, Company Director of Signify Research at the Cranfield Innovation Centre in the United Kingdom. “In a recent workforce census conducted by the Royal College of Pathologists, only three percent of UK pathology departments reported having enough staff to meet clinical demand. Shortages like these are being blamed for slowing the rate at which cancer biopsies are diagnosed, ultimately delaying cancer treatment and potentially sacrificing patient outcomes as a result.”
Concentriq Dx enables pathologists to make a primary diagnosis of diseases like cancer from digitized images of patients’ tissue biopsies, enabling laboratories to deliver more timely, higher quality diagnoses. By centering the practice of pathology around images instead of physical glass slides, Concentriq Dx automates time consuming and error-prone manual tasks and streamlines access to specialized expertise.
“With Concentriq Dx, we are laying the foundation for the next generation of digital pathology at a crucial time,” said David West, CEO of Proscia. “The challenges faced in Europe are reflective of global trends and highlight the need to accelerate diagnostic workflows and improve accuracy. Concentriq Dx can drive costs out of the health system, relieve overburdened pathology laboratories, and, most importantly, quickly get accurate answers to physicians and their patients. With this CE Mark, Proscia is accelerating its entry into the worldwide clinical market.”
Concentriq Dx works with any scanner and laboratory information system (LIS), offering seamless integrations with 3DHISTECH, Hamamatsu, and Leica among other leading solutions. It also offers flexible cloud and on-premise deployment options to meet the current and future needs of laboratories transitioning to modern, image-centric digital pathology. To learn more about using Concentriq Dx in your laboratory, join Proscia’s demonstration webinar on Thursday, 21 November, at 14:00 GMT.*
About Proscia
Proscia is an AI software company that is changing the way the world practices pathology to transform cancer research and diagnosis. With the company’s Concentriq digital pathology platform and pipeline of AI algorithms, laboratories are leveraging new kinds of data to improve patient outcomes and accelerate discoveries. Proscia’s team of technologists, scientists, and pathologists is bringing a fresh approach to an outdated industry, helping the world to keep pace with the increasing demand for pathology services and fulfill the promise of precision care. For more information, visit proscia.com.
*In the U.S., Concentriq Dx is not cleared by the FDA for use in primary diagnosis.
Source: Proscia
