BioReference Labs Goes Live With Digital Pathology Plus AI

BioReference Labs Goes Live With Digital Pathology Plus AI

BioReference Labs Goes Live With Digital Pathology Plus AI

OPKO’s BioReference Labs (Elmwood Park, NJ) went live in December with new whole-slide imaging scanners from Leica Biosciences (Buffalo Grove, IL). The scanners have been integrated with a digital pathology solution, PathFlow, made by Gestalt Diagnostics (Spokane, WA). PathFlow is a cloud-based software system that has helped integrate BioReference’s LIS, workflow and scanned slide images with artificial intelligence algorithms developed by MindPeak (Hamburg, Germany). BioReference is also using PathFlow for slide image management and archival storage.

BioReference is using MindPeak’s AI tool (named BreastIHC) to detect and quantify breast cancer cells from digitized slide images with immunohistochemistry at its main laboratory in northern New Jersey. Pathologists can access their case and slide images securely on their computer monitors and use their mouse to outline regions of interest (ROI). All cells within this outlined ROI are instantly classified into positively stained tumor and unstained tumor cells. The panel of algorithms include five key tumor markers (ER, PR, Ki-67, HER2, and P53) which can be counted and scored.

Eventually, Dan Roark, Chief Executive Officer, Gestalt Diagnostics, expects the AI algorithms to both automatically identify the regions of interest in addition to performing IHC marker positivity scoring.

Digital Pathology & AI Market Growth
Separately, Roark says that after more than 10 years of limited adoption, digital pathology is finally starting to take off in the clinical market in the United States. Whole slide scanners have gotten quicker and less expensive. For example, it used to take 8-10 minutes to scan a slide but now takes as little as 30 seconds. But the biggest driver is the pathologist efficiency gains obtained when AI is applied to digitized slides. “The number of RFP requests we receive is exploding,” says Roark.

Worldwide Opportunities for U.S.-Based Pathologists
The U.S. has more working pathologists per capita than most other countries. For example, there are approximately 20,000 actively practicing pathologists in the United States, according to the American Medical Association. This works out to a ratio of one pathologist for every 17,000 people.

CDx Diagnostics Leads In Digital Pathology

CDx Diagnostics Leads In Digital Pathology

CDx Diagnostics Leads In Digital Pathology

CDx Diagnostics (Suffern, NY), which specializes in oral, esophageal, and laryngeal cancer testing, is by far the biggest digital pathology lab as measured by volume of Part B claims for CPT 88361. CDx was paid for 55,082 Part B tests for CPT 88361 (including combined global, TC-only and PC-only claims) in 2019, according to provider utilization and payment data from CMS.

CPT 88361 is used to bill Medicare for digital quantification of HER2, estrogen receptor (ER), progesterone receptor (PR) and Ki-67 for breast cancer. This code can also be used for digital analysis of other cancers, including oral and esophageal cancers.

NeoGenomics has four labs (California, Florida, Michigan and Texas) in the top 25 with a combined total volume of 19,950 Part B allowed tests for CPT 88361 in 2019.

Sonic Healthcare USA has two lab locations (New York and Texas) that performed CPT 88361 with a combined volume of 6,760 allowed Part B tests for CPT 88361.

Overall, Medicare Part B allowed volume for CPT 88361 totaled 191,205 tests in 2019, down 10% from 212,003 tests in 2018.

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Alverno Labs To Implement Artificial Intelligence For Pathology

Alverno Labs To Implement Artificial Intelligence For Pathology

Alverno Labs To Implement Artificial Intelligence For Pathology

Alverno Laboratories (Hammond, IN), which transitioned to digital pathology in 2019 when it implemented Philips IntelliSite Pathology Solution, now says it will add artificial intelligence to aid its pathologists in cancer diagnosis. Alverno will use the Galen AI system developed by Ibex
Medical Analytics (Tel Aviv, Israel). Ibex’s Galen platform recently received the Breakthrough Device Designation from FDA, which will help fast track the clinical review and clearance process, and is CE marked in Europe for
breast and prostate cancer. Alverno is an independent lab owned by Franciscan Alliance and AMITA Health. Alverno manages a core lab and 32 hospital labs in Indiana and Illinois. It consults on 150,000 histological cases per year, which translates to more than 1.1 million tissue slides.

UltraClinics Aims to Spread Telepathology

UltraClinics Aims to Spread Telepathology

UltraClinics Aims to Spread Telepathology

UltraClinics Inc. (Tucson, AZ) has begun marketing a telepathology service that will allow diagnostic imaging centers and outpatient surgery centers to offer their patients same-day anatomic pathology reports from on-site tissue biopsies, Ronald Weinstein, M.D., 67, chairman of UltraClinics, tells LE. UltraClinics is a for-profit spin-off company of the University of Arizona and its renowned telemedicine program.

Weinstein says the system is currently in use at two locations in Arizona. The University Physicians Tucson Breast Center is offering same-day pathology reports for breast cancer biopsies. And the University Physicians Hospital at Kino (Tucson) is offering the service for both breast and prostate cancer biopsies. Both sites have connected with University Physicians Healthcare for professional services. Weinstein says UltraClinics will add a dermatopathology service soon as well.

The service requires each outpatient site to invest roughly $200,000 to set up a rapid histology lab, microtome, digital slide scanner, and electronic medical record (EMR). The outpatient site prepares a patient biopsy slide, and then electronically transmits a high-resolution image of the entire slide to an off-site pathologist for professional interpretation. The pathologist transmits the lab report into the patient’s EMR. The whole process is usually completed within five hours versus more than two weeks for traditional anatomic pathology reports, according to Weinstein.

He says the service allows referring physicians to consult with their patients about the pathology results on the same day as the biopsy procedure. It also makes it easier to obtain a second opinion on the pathology report, he adds.

Weinstein, who is also head of pathology at the University of Arizona and co-founder of the digitalslide-scanning company DMetrix (Tucson), is hoping to install the UltraClinics’ system at more than 500 outpatient sites in the United States over the next five years. He views UltraClinics as a “turnkey solution” that can connect any pathologist with any hospital or outpatient clinic in the world.

In fact, Weinstein says that foreign-born pathologists on the faculty at the University of Arizona are already making plans to link with their American-boarded pathologist colleagues in India and Shanghai, China. “Telemedicine will enable international group practices to form,” he says. “You’ll have a conference where three world experts can look at the slide at the same time.” He says UltraClinics will leverage time zone differences so that women who have breast biopsies late in the afternoon will be able to receive their lab reports the same day. He expects this service to be available in the near future.

But what about the controversy that outsourcing pathology work overseas is sure to bring? “I believe every American should have access to sub-specialty pathology. It’s quality that we should be focused on,” answers Weinstein.

Weinstein believes the movement towards cosumer-driven healthcare will minimize third-party reimbursement issues. “As we move from insurance company referrals toward HSAs [health savings accounts] that let patients determine where their specimens go, fast test results and second opinions will bring people to UltraClinics,” he says.