BioReference Labs Goes Live With Digital Pathology Plus AI

by Jondavid Klipp | Feb 15, 2022 | AI, Artificial Intelligence, BioReference Labs, Digital Pathology

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.

Publicly-Traded Lab Revenue Falls 1.4% In First-Half 2020

by Jondavid Klipp | Sep 15, 2020 | BioReference Labs, Labcorp, Quest Diagnostics, Sonic Healthcare

Publicly-Traded Lab Revenue Falls 1.4% In First-Half 2020

On a combined basis, 20 publicly-traded labs reported a revenue decrease of 1.4% to $9.8 billion during the first six months of 2020 (after adjusting for acquisitions), according to financial reports collected by Laboratory Economics.

Among five national clinic al labs (Quest Diagnostics, LabCorp, Sonic, BioReference and Enzo), combined revenue fell by 3.1% (after adjusting for acquisitions). BioReference had the strongest revenue growth, up 18% to $421.8 million, driven by Covid-19 PCR testing. BioReference processed approximately 2.2 million Covid-19 PCR tests during the first six months of 2020.

Among 15 specialty and genetic testing labs, combined pro-forma revenue increased by 7.3%.

Pro-forma revenue growth was fastest at DermTech, up 98.4% to $2.4 million. Other fast-growing companies included Castle Biosciences, up 54.9% to $30.1 million; Guardant Health, up 47.7% to $133.8 million; and CareDx, up 39.6% to $80.2 million.

Top 25 Fastest-Growing Labs by Medicare Part B Volume of Services

Top 25 Lab and Pathology Companies Receiving PRF Payments

by Jondavid Klipp | Jul 15, 2020 | BioReference Labs, Exact Sciences, Labcorp, Quest Diagnostics

Top 25 Lab and Pathology Companies Receiving PRF Payments

Not surprisingly, Quest Diagnostics ($65 million) and LabCorp ($56 million) top the list in terms of highest PRF payments received by lab and pathology companies. Exact Sciences, including Genomic Health, received $23.5 million, while Sonic Healthcare, including Aurora Diagnostics, received $12.4 million. In total, the top 25 lab and pathology companies received $222.6 million in PRF payments.

BioReference Wins Lab Contract With Westchester Medical Center

by Jondavid Klipp | Jul 15, 2020 | BioReference Labs

BioReference Wins Lab Contract With Westchester Medical Center

OPKO’s BioReference Laboratories (Elmwood Park, NJ) has signed a long-term service contract with the Westchester Medical Center Health Network (Valhalla, NY) to provide inpatient lab administrative services, reference testing and outreach testing services.

WMCHealth has 10 hospitals on eight campuses across the Hudson Valley Region of New York, including Westchester Medical Center (885 beds) and MidHudson Regional Hospital (243 beds). Altogether, WMCHealth has an annual laboratory department budget of approximately $65 million and performs over seven million lab tests per year.

Under the agreement, BioReference will provide inpatient lab administrative services and purchasing management services for lab equipment and supplies initially for Westchester Medical Center.

In addition, BioReference’s main lab in northern New Jersey will become the primary reference lab and perform clinical lab outreach testing for the entire hospital network. The agreement does not involve anatomic pathology services.

Jon Cohen, MD, Executive Chairman at BioReference, expects the company to sign similar agreements with other health systems in the future.

Majority Of NYC Nursing Home Employees Have Had Covid-19

by Jondavid Klipp | Jul 15, 2020 | BioReference Labs, Covid Testing, COVID-19

Majority Of NYC Nursing Home Employees Have Had Covid-19

BioReference Labs reports that Covid-19 antibody testing it performed on nursing home employees throughout New York State in May-June showed a 29% positivity rate. New York City nursing home employees were found to have the highest positivity rate (55%).

During the same time period, BioReference performed PCR-based molecular tests for active Covid-19 infection and found a 2.9% positive rate throughout the state, including a 4.6% positive rate for New York City nursing home employees.

The testing was performed as a result of a New York State mandate (effective May 10) that all personnel at nursing home and adult care facilities be tested for active Covid-19 infection using PCR-based molecular testing, twice per week. In addition, at the start of the program, many nursing homes asked that employees be tested for antibodies at the same time.

BioReference uses the Roche Elecsys Anti-Sars CoV-2 assay for antibody testing. Overall, BioReference tested 3,488 nursing home employees in New York State (primarily in May) for antibodies and found 1,010 positive cases. “With 29% of employees testing positive for antibodies, an extrapolated estimate for the 140,000 total nursing home staff in New York State suggests as many as 41,760 nursing home staff members in the state could have had Covid-19 prior to early May,” according to Jon Cohen, MD, Executive Chairman at BioReference.

Covid-19 Situation Update At Five Laboratories

by Jondavid Klipp | May 15, 2020 | American Health Associates, ARUP Laboratories, BioReference Labs, COVID-19, Northwell Health Labs, Viracor Eurofins Laboratories

Covid-19 Situation Update At Five Laboratories

Viracor Eurofins Laboratories (Lee’s Summit, MO) has the capacity to perform 2,000 PCR-based Covid-19 tests per day; however, about 50% of that capacity is currently unused, according to Steven Kleiboeker, PhD, Vice President of Research and Development. Nationwide, Eurofins U.S. Clinical Diagnostics, which includes Viracor and six other laboratories, has the capacity to run up to 10,000 PCR tests per day and expects to triple that number by the end of this month.

Viracor launched Covid-19 antibody testing on May 5 and has the capacity to perform more than 2,000 tests per day with a 24-hour turnaround from specimen receipt. Nationwide, Kleiboeker says that Eurofins’ seven labs can currently perform up to 10,000 antibody tests per day with capacity expected to triple by the end of this month.

Kleiboeker expects the demand for Covid-19 testing to increase dramatically as lockdowns in many states have begun to be lifted. That being said, Eurofins currently has excess testing capacity. “This is due to a variety of factors, including hospitals taking their testing in-house, supply-chain issues, and on the coasts, exclusive deals between the top insurance companies and the two largest labs,” according to Kleiboeker.

ARUP Laboratories
ARUP Labs is currently performing between 3,000 and 3,500 PCR-based Covid-19 tests per day and steadily increasing its capacity, according to Julio Delgado, MD, Chief Medical Officer and Director of Labs. He says that the swab and test kit supply situation has improved over the past few weeks and that ARUP has expanded its Covid-19 testing from Utah patients only to nationwide. In addition, ARUP began Covid-19 antibody testing in late April and is now performing about 5,000 antibody tests per day with steadily increasing capacity.

Northwell Health Labs
Northwell is currently performing about 2,000 PCR-based Covid-19 tests per day, according to James Crawford, MD, PhD, Senior Vice President for Laboratory Services. He says daily positivity rates for Covid testing peaked at 63% on March 31 and have now fallen to roughly 15%. In response to shortages, Northwell has begun using its own self-manufactured 3D swabs, which were clinically validated before deploying. In addition, Northwell started performing antibody testing on May 1 using multiple commercial platforms. Northwell is currently performing about 5,000 antibody tests per day and is in the process of testing its 70,000 employees.

American Health Associates
American Health Associates (Davie, FL), which provides lab testing services to more than 4,000 nursing homes and assisted-living facilities, recently began performing PCR-based Covid-19 testing and serum antibody testing at its corporate laboratory near Miami. Previously, AHA had sent its Covid-19 test samples to LabCorp. AHA is using the 7500 Fast Dx instrument from Thermo Fisher Scientific in combination with Thermo’s 96 Kingfisher auto extraction unit for PCR-based Covid-19 testing. AHA will be using Abbott’s Covid-19 antibody test. In addition, AHA plans to soon add Covid-19 testing capabilities to its labs in Atlanta and Cincinnati, according to CEO Chris Martin. AHA is currently performing an average of roughly 100 PCR-based Covid-19 tests per day and 350 antibody tests. Martin expects AHA’s Covid-19 testing volume to expand rapidly in the coming weeks.

BioReference Labs
To date (through May 6), BioReference has performed approximately 700,000 PCR-based Covid-19 tests, is currently performing about 20,000 tests per day, and plans to reach 40,000 by the end of the month. In late April, BioReference started offering Covid-19 antibody testing. Capacity is currently 20,000 tests per day and is expected to reach 400,000 tests per day in June, according to Jon Cohen, MD, Executive Chairman of BioReference Labs. Roche will be the primary antibody assay used by BioReference.