Royal Philips is seeking approval from the US Food and Drug Administration (FDA) for expanded indications of its IntelliSite digital pathology solution.
The company has completed the multicenter pivotal validation study, which compared diagnoses determined by pathologists from digital whole slide imaging to traditional optical diagnoses through a microscope.
Philips intends to submit the results to the FDA to get de novo clearance for the expanded indications of the digital pathology solution.
With around 16,000 reads across 2,000 cases, the company carried out the trial at four clinical study sites, including Cleveland Clinic, University of Virginia, Miraca Life Sciences and Advanced Pathology Associates.
The firm has designed the study to assess the difference in major discordance rates between diagnoses made with digital pathology or microscope.
According to the company, the study reviewing and diagnosing of surgical pathology tissue slides from a range of tissues met its pre-specified endpoint.
Philips digital pathology solutions general manager said Russell Granzow said: “Philips is committed to working alongside regulators and pathologists to better understand and evaluate the clinical validity of this technology.
“I wish to thank our clinical partner sites for their diligence during this seminal study.”
The study principal investigator Dr Clive Taylor said: “The design of this study holds the original diagnosis to be the truth and that provides us with a base to compare all readings by all pathologists in the study.”
Image: Royal Philips has completed pivotal validation study of IntelliSite digital pathology solution. Photo: courtesy of Koninklijke Philips N.V.