The 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 the first AI-based product in pathology to be used in routine clinical practice in the United States.

January 5, 2022 — Hamburg, Germany, based Mindpeak and Spokane, Wash., based Gestalt Diagnostics have achieved a major success on their way to improve patient care with Digital Pathology and Artificial Intelligence (AI). US based BioReference Laboratories, Inc., an OPKO Health company and one of the largest laboratories in the United States with 19 million patients per year, is now using Gestalt Diagnostic's Digital Pathology Solution with Mindpeak's AI-based cancer diagnostics BreastIHC algorithm in routine practice. The algorithm is being used for the quantification of breast cancer cells.

The 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 the first AI-based product in pathology to be used in routine clinical practice in the United States.

"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," said, 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."

"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", said Dan Roark, Chief Executive Officer, 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."

"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," explained Felix Faber, CEO of Mindpeak.

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. 

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. A great advantage is its ability to differentiate between tumorous and non-tumorous structures, improving the scoring in the tumor microenvironment. "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, easy to use digital platform for pathology laboratories. "Through our platform, we enable Pathologists to interpret, and diagnose patient cases quickly, efficiently, and in a fully automated fashion. We provide enterprise solutions and services to transform anatomic pathology laboratories from glass slides, microscopes and couriers to a fully interoperable, automated, electronic digital workflow", says Lisa-Jean Clifford, COO & Chief Strategy Officer, Gestalt Diagnostics.

For more information: www.bioreference.com

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