What You Should Know:
- 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.
Advancements in Digital Pathology: Study Highlights Non-Inferiority of Concentriq AP-Dx
Bend Medical Foundation and Spectrum Healthcare Partners participated in a study showcasing the non-inferiority of diagnoses made on Concentriq AP-Dx compared to traditional glass slide reads. The study revealed a minimal difference in major discordance rates between digital and microscope reads, highlighting the robustness of Concentriq AP-Dx. Digital pathology, which replaces the microscope with high-resolution images containing over 1 billion pixels, holds immense potential for advancing precision medicine and improving efficiency in laboratories. With hiring for pathologists at a peak due to increasing cancer cases, digital pathology emerges as a crucial tool. Proscia, the company behind Concentriq AP-Dx, holds 510(k) clearance and CE-IVDR certification, positioning it as a trusted provider worldwide with endorsements from top diagnostic laboratories and pharmaceutical companies.
“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.”
