Is Alzheimer’s Testing the Next Big Lab Market?

Is Alzheimer’s Testing the Next Big Lab Market?

Is Alzheimer’s Testing the Next Big Lab Market?

The FDA cleared the Alzheimer’s drug Leqembi (lecanemab) in July 2023. The drug marked the first treatment for slowing Alzheimer’s progression and cognitive decline to make it through the agency’s traditional pathway. But Leqembi, which was developed by Eisai (Tokyo) and Biogen (Cambridge, MA), has fallen far short of its goals for patient prescriptions. That’s partly because the current methods for diagnosing Alzheimer’s—ex- pensive brain imaging scans and invasive cerebral spinal fluid (CSF) tests— are acting as bottlenecks. However, new blood tests for Alzheimer’s are
being introduced that could give more patients access to treatment.

An estimated 6.9 million Americans aged 65 and older are currently living with Alzheimer’s disease, according to the Alzheimer’s Association (Chicago, IL). And an estimated 500,000 new cases of Alzheimer’s will be diagnosed this year. The new Alzheimer’s treatment Leqembi has a list price of $26,500 per year.

In addition, the FDA recently cleared Eli Lilly’s Alzheimer’s drug Kisunla (donanemab), which has a list price of $32,000 per year. Both drugs are intravenous infusions that attack a protein (amyloid) that clumps into plaques in the brains of people with Alzheimer’s. Both drugs slow disease progression (e.g., memory loss or other cognitive problems) but do not stop or reverse it. In addition, at least nine pharmaceutical companies have clinical trials underway for new Alzheimer’s drugs. Those in late-stage trials for oral pill treatments include BioVie (NE3107) and AB Science (masitinib).

But these drugs rely on PET scans and CSF tests to identify Alzheimer’s patients for treatment. “The availability of more affordable and minimally invasive diagnostic tools will help support broad access for the management of Alzheimer’s disease,” according to Eisai’s global Alzheimer’s disease officer, Keisuke Naito.

New blood-based immunoassays that identify the proteins associated with Alzheimer’s are likely to become the new standard for screening and monitoring the disease. The potential lab market could reach $500+ million per year. This estimate assumes 4 blood tests to identify and monitor each of the 500,000 new cases of Alzheimer’s each year at an average reimbursement of $260 per test (for two protein markers per test).

At the June 25th Annual CLFS Meeting with CMS to address rate setting for new codes, ACLA requested a Medicare rate of $130 per Alzheimer’s protein marker. Thus, a two-protein test (e.g., pTau181 & Abeta42) would be reimbursed $260. This level of reimbursement would match the Medicare rate of $260 for Fujirebio’s FDA-cleared Lumipulse test. Coding and final rates will be announced by CMS later this year for an effective date of January 1, 2025.

There are currently at least six Alzheimer’s lab tests on the market (see table). In addition, Danaher’s Beckman Coulter is developing a blood test for its immunoassay analyzers. Beckman is expected to release a two-protein test (pTau217 & Abeta42) in RUO format later this year. Clinical data from the RUO test will be used to support an eventual FDA application.

Labcorp to Buy Tufts Outreach Lab Assets

Labcorp to Buy Tufts Outreach Lab Assets

Labcorp to Buy Tufts Outreach Lab Assets

Tufts Medicine (Boston, MA) is selling its clinical lab outreach business to Labcorp for an undisclosed amount. The transaction, which
does not involve anatomic pathology services, is expected to formally
close in October. Tufts says the sale is the first step towards a broader
partnership with Labcorp. The announcement comes as Tufts endures
prolonged financial difficulties that led Fitch Ratings to downgrade its
debt rating from BBB+ to BBB earlier this year.

Tufts Medicine (TM) includes three hospitals in the Boston area, including Tufts Medical Center (405 beds), Lowell General Hospital (390 beds) and Lawrence Memorial Hospital of Medford (216 beds). It also includes Tufts Medicine Integrated Network, which has more than 1,800 affiliated community and academic physicians.

The annual lab department budget at TM’s three hospitals is a combined $122 million, according to Medicare Hospital Cost Reports. Laboratory Economics estimates that TM’s clinical lab outreach business has annual revenue of roughly $30 million. Labcorp is expected to make job offers
to nearly all 574 TM lab employees affected by the sale.

TM lost $399 million on operations in the fiscal year ended Sept. 30, 2022. TM management estimates that approximately $129 million of the losses were related to one-time items, including the stoppage of elective surgeries due to the pandemic (a $58 million loss of revenue) and installation of the electronic medical records system Epic ($71 million). The largest component of the rest of the operating loss was $217 million for increased staffing costs. The amount TM paid for contract labor increased an incredible 1,423%, to $155 million in the 12 months that ended Sept.
30, 2022, compared to pre-pandemic in 2019.

In addition, TM is facing stiff competition for hospital patients from Massachusetts General Hospital (Boston), which is aggressively competing for managed care contracts.

Sizing Up the Boston Lab Market
The Boston-Cambridge-Newton metropolitan area has a population of 4.9 million with an estimated physician lab services market of $650 million per year.

Quest Diagnostics has by far the largest market share in the Boston area. Quest purchased the Worcester-based clinical lab outreach business of UMass Memorial Medical Center in 2013. Quest then consolidated testing at a new 200,000-square-foot lab in Marlborough (30 miles west of Boston). Quest has a total of more than 100 patient service centers in the Boston area. It generates an estimated $350 million in revenue from physician office clients in the Boston area.

Labcorp has 15 PSCs in the Boston area and estimated physician client revenue of $50 million… per year (excluding Tufts Medicine deal). Labcorp’s nearest major regional lab is located in Raritan, New Jersey (~5-hour drive)

Mass General Brigham provides lab outreach testing at several hospitals in the Boston area, including Massachusetts General Hospital (1,019 beds), Brigham and Women’s Hospital (812 beds) and Newton-Wellesley Hospital
(273 beds). Total estimated annual lab outreach revenue from the physician office market is $75 million.

Beth Israel Lahey Health operates its biggest hospital-based outreach
labs at Lahey Hospital and Medical Center Burlington (345 beds), Beth
Israel Deaconess Medical Center (743 beds) and Winchester Hospital (194 beds). Total estimated annual lab outreach revenue from the physician office market is $60 million.

Labcorp to Buy Tufts Outreach Lab Assets

Labcorp Completes Outreach Lab Deal With RWJBarnabas Health

Labcorp Completes Outreach Lab Deal With RWJBarnabas Health

Labcorp has completed its acquisition of RWJBarnabas Health’s outreach laboratory business and select related assets (see LE, August 2022). RWJBarnabas Health (West Orange, NJ), which has 12 acute-care hospitals with 4,357 staffed beds, is New Jersey’s largest academic health system. Financial terms of the transaction were not revealed.

Clinical lab outreach testing from RWJBarnabas Health will be shifted to Labcorp’s regional laboratory in Raritan, New Jersey. Some STAT and same-day testing will be performed at select RWJBarnabas Health hospitals. Anatomic pathology services are not part of the deal and will not be affected.

In addition, any potential future reference testing relationship with RWJBarnabas Health would be independent of this transaction, according to a Labcorp spokesperson.

“This strategic business decision will provide a high-performing, streamlined outreach network to support our community,” according to John Doll, Senior Executive Vice President and Chief Operations Officer of RWJBarnabas Health. The arrangement is also expected to reduce out-of-
pocket lab costs for RWJBarnabas patients.

RWJBarnabas Health’s decision to sell its clinical lab outreach business comes as it struggles with investment losses, rising labor costs and inflation. In the six months ended June 30, 2022, RWJBarnabas Health reported a net loss of $489 million vs. a net gain of $325 million in the same period a year earlier; total revenue was up 14% to $3.651 billion.

Investment losses at RWJBarnabas Health totaled $729 million in the six months ended June 30, 2022. In addition, salaries and employee benefits increased by $264,375 or 18%; physician fees and salaries increased by $79,207 or 22%; and supplies and other expenses increased by $191,781 or 17%.

RWJBarnabas Health collected total Medicare Part B CLFS revenue of $6.3 million in full-year 2021. Laboratory Economics estimates that Medicare Part B CLFS represents 25% of the overall revenue at RWJBarnabas Health’s clinical lab outreach business (total annual revenue estimated at
$25 million).

Labcorp to Buy Tufts Outreach Lab Assets

Labcorp Completes Acquisition of PGDx

Labcorp Completes Acquisition of PGDx

Labcorp completed its previously announced (see LE, January 2022) acquisition of Personal Genome Diagnostics Inc. (PGDx-Baltimore, MD) on February 18. PGDx markets an FDA-cleared comprehensive tumor profiling test, PGDx ELIO tissue complete, that is covered by Medicare under the PLA code 0250U at a rate of $2,950. Labcorp paid $450 million in cash at closing
and will pay up to an additional $125 million based on PGDx achieving future performance milestones. The $575 million purchase price, including contingent performance payments, is equal to 14.4 times PGDx’s expected revenue of $40 million in 2022.

Labcorp to Buy Tufts Outreach Lab Assets

Labcorp To Buy PGDx For $575 Million

Labcorp To Buy PGDx For $575 Million

Labcorp (Burlington, NC) has agreed to acquire Personal Genome Diagnostics Inc. (PGDx-Baltimore, MD) for $450 million in cash at closing plus up to an additional $125 million based on future performance milestones. The transaction is expected to close in the first half of 2022.

PGDx was founded in 2010 by two cancer scientists, Luis Diaz, MD, and Victor Velculescu, MD, PhD, from Johns Hopkins University. The company received FDA clearance to market its comprehensive tumor profiling test kit, PGDx ELIO tissue complete, in May 2020. The test analyzes 505 genes
from FFPE tissue samples from advanced cancer patients to inform treatment decisions for 35 solid tumor types. PGDx ELIO is covered by Medicare under the PLA code 0250U at a rate of $2,920.

PGDx, which has 114 employees, recorded revenue of approximately $22 million in 2021. Revenue is expected to grow nearly 82% to $40 million in 2022. Labcorp expects the acquisition of PGDx to negatively impact its earnings slightly over the next couple of years, but provide returns in excess of the cost of capital by year five.

PGDx had raised more than $200 million from outside investors, including New Enterprise Associates, Bristol-Myers Squibb and Cowen Healthcare Investments.

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

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

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