Pathology News Roundup: March 22, 2022

First FDA Clearance for Scanner Agnostic Digital Pathology Software. Digital pathology and cancer informatics provider Inspirata announced that it has received U.S. Food and Drug Administration (FDA) clearance for its Dynamyx digital pathology software. This clearance enables Dynamyx customers to use whole slide images (WSIs) for primary diagnosis in place of traditional glass slides, yielding an array of powerful benefits to pathologists and laboratories.

Dynamyx holds the first FDA clearance for digital pathology software with multiple scanners. Inspirata says this highlights the company's core commitment to a scanner agnostic and open platform that will allow its customers to select the best scanners for their laboratory.

Image via Inspirata.

“FDA clearance for Inspirata’s Dynamyx software is exciting, as this will pave the way for more clinical adoption of digital pathology and AI tools for clinical applications, as well as teaching, education, and research,” said Dr. Anil Parwani, Vice-Chair of Anatomic Pathology at the Ohio State University’s Wexner Medical Center. “As a current user of Dynamyx, I am looking forward to using the intuitive user interface with the many annotation tools, universal viewer, and customizable third-party AI applications that can be made available as needed by the pathologists.”

In response to the COVID-19 pandemic in early 2020, the FDA and CMS announced temporary waivers of 510(k) requirements and CLIA licensing requirements, allowing Dynamyx to be used for primary diagnosis without the need of a 510(k). Despite this waiver, Inspirata pursued FDA clearance.

“Inspirata recognizes our customer’s desire to have the assurance of an FDA market clearance. We are confident that this significant milestone will help our customers communicate the maturity of digital pathology across their organization,” said Mark Lloyd, Executive Vice President and Founder of Inspirata. “We are immensely proud of our hard work leading up to this achievement and believe that FDA clearance is critical for all vendors for the long-term success of the industry.”

CAP Annual Report. The College of American Pathologists (CAP) released its 2021 Annual Report. 

The report outlines the financial health of the organization, as well as detailing advocacy wins, laboratory quality measures, and efforts to support the CAP membership.

CAP President Emily Volk, MD, FCAP, and CEO Stephen Myers state in the report's introduction, "The challenges we faced in 2021 required a strong, engaged membership, and we’re proud of how we’ve grown. One exciting development was the launch of the new MyCAP app, which improves member access to content and resources such as the Cancer Protocols and advocacy alerts when we need to mobilize to protect our patients and the profession. We continue our work to grow the pathology pipeline to sustain the future of our specialty. Recognizing the value of a diverse pipeline, we formed the first-ever Diversity, Equity, Inclusion Committee to support the visibility and participation of underrepresented pathologists."

Financially-speaking, the CAP's total 2021 operating revenues were $251.7 million, $3.1 million (1.2%) better than the Board-approved target and $14.3 million (6.0%) above fiscal year 2020 levels, as the CAP says nearly all revenue streams recovered faster than anticipated from the pandemic’s economic effect.