BioReference Labs to Use Gestalt for Digital Pathology

Goal is to expand use of digital pathology, AI, particularly in the analysis of breast cancer cases

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ONE OF THE NATION’S LARGEST CLINICAL LABORATORIEScis moving forward with plans to expand its use of digital pathology and whole-slide imaging. On Mar. 30, it was announced that BioReference Laboratories, Inc. would move forward with Gestalt Diagnostics’ PathFlow digital pathology solution. 

For the agreement with BioReference, Gestalt is partnering with MindPeak, of Hamburg, Germany, for digital image analysis algorithms that incorporate artificial intelligence (AI) and deep learning, and with Leica Biosciences of Buffalo Grove, Ill., as the provider for the whole-slide imaging scanners. 

BioReference is based in Elmwood Park, N.J., and is an OPKO Health company. The company operates 11 lab sites and serves about 19 million patients annually. It will begin deploying PathFlow in the second quarter of this year. 

Difficult Diagnostic Cases 

“BioReference is initially launching our PathFlow DP solution with breast cancer cases,” stated Lisa-Jean Clifford, COO and Chief Strategy Officer at Gestalt. “In this specialty, we will support their most difficult diagnostic cases with fully-integrated artificial intelligence (AI) algorithms.” 

Gestalt Diagnostics, based in Spokane, Wash., is a software and services company offering PathFlow, a digital workflow platform that provides pathologists with a comprehensive automated workflow engine, a full image-management solution and universal viewer. Its open digital pathology technology integrates with image analysis software and AI algorithms for cancer scoring and diagnosis support. PathFlow is compatible with existing pathology lab information systems. 

For BioReference, the agreement with Gestalt Diagnostics is a forward step to implement a pathologist workflow and productivity solution while also moving to the latest generation of digital scanner and AI image analysis technologies. 

Expand Pathology Offerings 

“This is an upgrade from what we currently use in surgical pathology, and we view PathFlow as an enhancement of technology and software,” said Ellen Beausang, Senior Vice President, Advanced Diagnostics, BioReference, Elmwood Park, N.J., in an exclusive interview with The Dark Report. “This will enable us to expand our offerings to current and new customers.” 

Ongoing advances and improvements in digital pathology tools and systems triggered this decision at BioReference. 

“We have a pathology platform that we are sunsetting and we needed to do some upgrades and updates,” Beausang noted. “This was an opportunity to look at the market, assess the digital pathology solutions, and identify what was best for us. 

“We felt Leica had many years of experience with digital pathology, and pairing their hardware system with Gestalt’s pathology workflow platform will give us one of the most innovative workflows in the market today. Plus, the artificial intelligence tools for digital image analysis give us new capabilities.” 

BioReference has short-term and long-term strategies for how it wants to leverage digital pathology to deliver more value to referring clients while expanding market share. 

Client Collaborations 

“In the near-term, we will predominantly use the new digital pathology (DP) resources for our current digital customers,” Beausang explained. 

“For the long-term, we want Gestalt’s open-workflow solution because it has value in enabling potential collaborations with the client laboratories and hospitals that BioReference supports. This system gives us the ability to add new services in digital pathology—should we decide to do that.” 

In the first phase of this agreement, BioReference will give priority to its breast prognostic testing. “In the Elmwood Park site, we perform our IHC (immunohistochemistry) prognostic testing. We run about 20% of the IHC tests on the whole-slide imaging instrument,” she noted. “As part of bringing this new DP program up, we are sunsetting our current whole-slide imaging platform. 

Tweak the AI Algorithms 

“Both our chief medical officer and our internal medical team were very involved in our initial package from Gestalt,” Beausang added. 

“We gain the ability to tweak the algorithms (developed by Gestalt) and change the AI offering for breast that they have (AI breast diagnostic algorithms ER, PR, Ki-67, HER2, and P53 in partnership with MindPeak).”

Image Analysis Can Add Value in QC 

WITH ITS LATEST STEPS to acquire and deploy the newest generation components of digital pathology—scanners, a pathologist workflow solution, and image analysis algorithms—the team at BioReference decided on the PathFlow system. 

Because it planned to buy the components from different companies, BioReference needed an open system to operate them. It chose Gestalt Diagnostics’ PathFlow for that open system. 

“Our system has the ability to support multiple different scanners (vendors and models) in multiple locations,” explained Lisa-Jean Clifford, COO and Chief Strategy Officer at Gestalt. “PathFlow can integrate with a lab’s LIS or with multiple LISs simultaneously. It provides that same interoperability with EMRs and EHRs and reporting systems, as well as artificial intelligence vendors and algorithms.” 

Clifford also mentioned that the ongoing improvement in the current generation of image analysis algorithms means that laboratories have another way to reduce malpractice lawsuits and reduce malpractice premiums. “Pathology laboratories—when considering the cost of lawsuits—see that there is significant value in deploying algorithms for specific use cases, such as QC (quality control) or second reads,” she noted. “This can more than pay for a labs’ investment in the AI. 

“In first read or diagnostic aid algorithms—if the algorithm draws a pathologist’s attention to the potential area of interest or region of interest and identifies abnormal or high potential for malignant cells—that helps narrow down the scope, improving diagnostic accuracy,” Clifford said.

Contact Ellen Beausang at media@bioreference.com; Lisa-Jean Clifford at 508/868-6827 or ljclifford@gestaltdiagnostics.com.

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