Pathware

Pathware is a medical technology company whose product, Bioptic, performs real-time biopsy quality assessment. The system is positioned to let clinical teams determine whether a tissue or cell sample is adequate for diagnosis at the point of collection, rather than after the specimen has been processed in a pathology laboratory.

The company frames the need for its technology around the rate of non-diagnostic samples and the downstream consequences for patients and providers. Its public materials cite that 20-25% of biopsies are inadequate for diagnosis in the absence of on-site quality assessment, leading to readmissions, repeat biopsies and extended waiting periods before a diagnosis is returned. Pathware also references the economics of on-site evaluation for pathologists, contrasting an average billing potential of $638 per hour for laboratory work with $88 per hour while performing on-site evaluation.

For hospitals and payers, Pathware points to roughly 2.7 million fine-needle aspiration biopsies collected each year at direct costs of about $3,000 per procedure, with repeat procedures and unnecessary surgeries aggregating to approximately $1.6 billion annually. It further cites that 92% of thyroidectomies following an indeterminate biopsy are later found to have been unnecessary, at about $11,000 per surgery, representing an estimated $165 million in annual insurer losses.