Recent advances in biomarkers and imaging capabilities have improved the diagnosis of Alzheimer’s disease (AD). Fujirebio Diagnostics Inc. aims to further expand the arsenal of AD diagnostics with its Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test. On Wednesday, the company said it had filed a 510(k) submission with the U.S. FDA for premarket clearance of the Lumipulse G β-Amyloid IVD.

If cleared, it would be among the first commercially available in vitro diagnostic (IVD) tests in the U.S. to aid in assessing patients who may have AD. “We are hopeful to get our clearance in Q1 2021,” Hiroshi Sekiya, Fujirebio’s senior manager for product and customer management, told BioWorld.

The test won an FDA breakthrough device designation in 2019.

Need for better diagnostics

An estimated 5 million Americans have AD. Current options for assessing amyloid pathology include an amyloid PET scan, often considered the definitive test for AD, but that can be costly and time-consuming to perform. PET imaging is also not routinely covered by insurers for AD diagnosis.

Lumipulse G β-Amyloid Ratio (1-42/1-40) is a quantitative test using cerebrospinal fluid to estimate the presence of amyloid pathology in adults age 50 and older. The test combines the concentrations of Lumipulse G β-Amyloid 1-42 and Lumipulse G β-Amyloid 1-40 derived from cerebral spinal fluid into a numerical ratio of β-amyloids 1-42 and 1-40, major components of the amyloid plaques found in the brains of patients with AD.

Assessing levels of beta amyloid has been shown in both research and clinical practice to help in evaluating AD and other forms of cognitive decline. An FDA-cleared IVD test, rather than the more common and less regulated laboratory developed tests that receive CLIA certification, could expand access to standardized AD diagnostics to a wider range of health care providers. That, in turn, could help to cut costs to providers.

“The lack of effective and accessible clinical tools for patients who could be on the pathway to develop Alzheimer’s disease contributes to its late diagnosis and inadequate treatment,” said Monte Wiltse, president and CEO of Fujirebio Diagnostics. “We designed our Lumipulse G β-Amyloid Ratio test to help physicians triage their patient much sooner when effective interventions are more feasible using these well-researched β-amyloid biomarkers.”

The Lumipulse beta amyloid test is analyzed on Fujirebio’s fully automated Lumipulse G1200 instrument system. “Time to first result on the Lumipulse G1200 is 30 minutes, with subsequent tests generated every 30 seconds,” Sekiya said.

As a breakthrough technology, Fujirebio’s test is eligible for additional reimbursement in the hospital setting under the new technology add-on payment (NTAP) program, part of the Hospital Inpatient Prospective Payment System. CMS has also proposed a rule to establish a Medicare Coverage of Innovative Technology (MCIT) pathway that would begin national Medicare coverage on the date of FDA market authorization and continue for four years.

Malvern, Pa.-based Fujirebio already has the CE mark for its beta amyloid test, as well as an assay to assess abnormal changes in Tau associated with AD. Both tests “are now being utilized in routine research and clinical use throughout Europe in memory centers and laboratories,” Sekiya said.


Other companies are vying in the AD diagnostics space. In May, St. Louis-based startup C2n Diagnostics LLC got a $20 million shot in the arm for its Alzheimer’s blood test, APTUS-Aβ, from the philanthropy group GHR Foundation. The test measures various types of beta amyloid and then factors in other data, such as age, to develop a probability score for amyloid-related changes in the brain.

San Diego-based Cortechs Labs Inc. has developed an automated PET image analysis tool that detects changes in specific brain structures associated with AD, vascular dementia, epilepsy, multiple sclerosis and other neurological disorders. The graphical presentation of the data can also be used to track changes over time to monitor patients’ response to therapy or deterioration.

With the prospect of better diagnostics for AD and the potential for earlier intervention comes the need for effective new drug therapies. But the pathway to approval is not always straight or certain.

Earlier this month, an FDA advisory panel shot down Biogen Inc.’s much-hyped AD candidate, aducanumab, after FDA biostatistics analysts raised “concerns about the consistency of evidence” demonstrating the drug is effective in treating AD. Aducanumab, the anti-amyloid beta monoclonal antibody partnered by Biogen and Tokyo-based Eisai Co. Ltd., received priority review this summer when its biologics license application was accepted for FDA review.

Meanwhile, researchers at Lund University in Sweden have shown that by combining the levels of plasma P-tau181 and neurofilament light in the blood of people with mild cognitive impairment (MCI), they can predict their risk of developing AD. “Plasma biomarkers of core AD features may aid in individualized risk assessment for patients with MCI, which represents a critical step towards accessible precision medicine for cognitive diseases,” the researchers said, adding that standardized assays and further validation of their findings are needed.

In conjunction with their work, the team has developed an app that physicians can use to assess a patient’s risk of AD. The study was published Nov. 30, 2020, in Nature Aging.