NEW YORK – High-sensitivity immunoassay firm Quanterix is counting on multi-marker testing to set it apart in the increasingly crowded blood-based Alzheimer’s diagnostics space.
Discussing the company’s diagnostics plans during a conference call Tuesday following release of its preliminary Q3 2024 financial results, Quanterix President and CEO Masoud Toloue said the firm expects its five-marker LucentAD Complete will offer advantages in performance compared to single-marker Alzheimer’s diagnostics and will garner “materially larger” reimbursement than single-marker tests.
Quanterix has been among the pioneers of blood-based testing for Alzheimer’s disease as its high-sensitivity Simoa immunoassay technology allows it to measure neurology markers present in low concentrations in blood. In recent years, however, a number of testing firms, including large players like Roche, Danaher's Beckman Coulter, Quest Diagnostics, and Laboratory Corporation of America, have either announced plans to launch blood-based Alzheimer’s tests or have released such tests commercially. In September, Fujirebio Diagnostics filed its Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio in vitro diagnostic test with the US Food and Drug Administration, making it the first company to take this step.
Quanterix believes LucentAD Complete’s multi-marker approach will distinguish it from other offerings. Specifically, Toloue said that compared to single-marker tests like phosphorylated-tau 217, the LucentAD Complete test is able to reduce the proportion of patients who receive indeterminate test results, which could cut down on the number of patients who require additional testing, either through cerebrospinal fluid testing or PET imaging.
Toloue said the company had found that the test, which it introduced in October, reduced indeterminate results by threefold compared to testing with p-tau 217 alone. LucentAD Complete measures p-tau 217, NFL, GFAP, and β-Amyloid 40 and 42 and uses an algorithm to combine those measurements into a single score assessing the likelihood that an individual has the amyloid brain pathology characteristic of Alzheimer’s disease.
Quanterix continues to develop its single-marker p-tau 217 Alzheimer’s test, with Toloue noting that it expects to complete clinical validation studies for that test in 2025. He added that the company plans to use the same clinical trials to support its FDA submission for LucentAD Complete. "We expect its regulatory timeline to closely trail our single-marker p-tau 217 process," Toloue said.
He added that Quanterix expects the multi-marker test to garner more favorable reimbursement than single-marker assays. The Centers for Medicare and Medicaid Services (CMS) recently proposed that a number of new Alzheimer's biomarker codes be cross-walked to the generic immunoassay code 83520, which pays $17. Toloue said the company believes those tests will ultimately be priced closed to the $90 to $130 range but noted that in any case it expects that as a multi-marker test LucentAD Complete will receive a higher price.
"We have high ambitions on what this reimbursement rate will be," he said.
Toloue said that Quanterix continues to pursue hospital partnerships to build out its Alzheimer's testing infrastructure. He also noted that in September its Chinese partner UltraDx received Chinese IVD clinical registration for its UD-X Simoa system, making it available for clinical applications in China.
"With approximately 10 million individuals estimated to have Alzheimer's disease, China has been an early adopter of blood-based biomarker testing," he said. "We view China as an important region to build critical Alzheimer's testing infrastructure."
Ultimately, Toloue said, uptake of blood-based Alzheimer's diagnostics will hinge on the level of adoption of the anti-amyloid therapies available for the disease.
"I think the key driver for diagnostics will come down to the two therapies that are approved," he said. "If we start to see that ramp, I expect the demand for blood-based testing to also similarly ramp. So obviously we are paying very close attention to that."
Quanterix said its preliminary Q3 2024 revenues were up 14 percent year over year.
For the three months ended Sept. 30, the Billerica, Massachusetts-based company posted preliminary revenues of $35.7 million, up from $31.3 million in Q3 2023 as reported, or $31.6 million on a restated basis. This beat the consensus Wall Street estimate of $34.2 million.
In a statement, Quanterix said it needs to restate certain financial informations from earlier quarters to correct non-cash mistakes from those quarters.
Quanterix maintained its 2024 revenue guidance range of $134 million to $138 million.
The firm said it had an operating loss for the recently completed quarter of $11.2 million compared to $13.8 million a year ago as reported, or $13.3 million on a restated basis.
The company ended the quarter with $296.1 million in cash, cash equivalents, marketable securities, and restricted cash.
In Wednesday morning trading on the Nasdaq, Quanterix shares were down 5 percent to $14.38.