BioReference Laboratories—an OPKO Health company—will be utilizing new artificial intelligence-based diagnostics solutions for clinical routine pathology.

BioReference says it will be using Gestalt Diagnostic’s Digital Pathology solution in tandem with Mindpeak’s AI-based cancer diagnostics BreastIHC algorithm for routine quantification of breast cancer cells. 

“The combination of Gestalt’s digital workflow platform and MindPeak’s AI offers BioReference customers AI-assisted diagnostic tools that provides streamlined, optimal patient care,” says, Ellen Beausang, senior vice president of Advanced Diagnostics at BioReference Laboratories. “Patient care is placed at the forefront of innovation at BioReference and as an organization, we strive to deliver the best possible result for patients and their families.” 

Mindpeak’s AI software is integrated into Gestalt Diagnostics’s PathFlow platform for streamlined access and workflow for BioReference’s pathologists and external pathology customers. This makes BreastIHC one of the first AI-based products in pathology to be used in routine clinical practice in the United States. 

“This is a major advancement in the laboratory industry and we are proud to work closely with our customer, BioReference Laboratories, and our partner, MindPeak, to be able to accomplish such a historic milestone,” says Dan Roark, CEO, Gestalt Diagnostics. “BioReference is widely known for its innovation and mindset of embracing technology to enhance patient care while increasing efficiency, safety and accuracy. We are proud to have been selected by them to provide PathFlow as their digital pathology platform – enabling the seamless integration of AI directly within their pathology workflow.”

BioReference submitted a validation of the diagnostic tool as a Laboratory Developed Test (LDT) to regulatory authorities and received all necessary approvals and clearance for clinical routine use in the integrated combination of Gestalt’s digital pathology solution and MindPeak’s AI solution.  

“We are excited about this important step for improving patient care and improving patients’ lives. BreastIHC is now being used in clinical routine in the US as the first AI-based solution ever. BioReference Laboratories is a well-known innovation leader in the field and can now leverage the power of AI solutions in its digital workflow,” says Felix Faber, CEO of Mindpeak.

BreastIHC is a plug-and-play solution that enables pathology laboratories to instantaneously detect, classify and quantify breast cancer cells stained with immuno-histochemistry. BreastIHC classifies cells into positively stained tumor and unstained tumor cells.

“Extensive validation of our algorithm in multiple contexts has shown its reliability under a wide range of laboratory conditions and customers confirm significant increase in reporting speed and throughput,” says Faber. 

At BioReference, the analysis tool BreastIHC is deeply integrated into the image management system platform, PathFlow, of Gestalt Diagnostics. PathFlow is a universal, digital platform for pathology laboratories.