Quest Will Offer FDA-Cleared Fujirebio Blood Test to Detect Alzheimer Disease

_{Courtesy of Quest Diagnostics}

Quest Diagnostics announced today that it will offer a newly FDA-cleared blood test to aid in the diagnosis of Alzheimer disease (AD) before the end of the summer.¹

According to the July 9 statement, the company will begin providing laboratory testing based on the Lumipulse G pTau 217/β-Amyloid (Aβ) 1-42 Plasma Ratio test developed by Fujirebio, the first blood-based in vitro diagnostic (IVD) test authorized by the FDA to help detect the amyloid pathology characteristic of AD in adults aged 50 years and older exhibiting signs and symptoms of cognitive decline.¹

“Our goal is to advance access to quality and innovative blood-based tests for [AD]. Adding the Fujirebio test to our existing blood-based tests provides the many physicians we serve with another powerful option for assessing patients for [Alzheimer] disease,” Kathleen Valentine, vice president and general manager of neurology at Quest, said in a statement.

In a clinical study of 499 adults representative of the US population, the test demonstrated a 92% positive predictive value and 97% negative predictive value for AD when using a dual cut point; 20% of participants required further confirmatory testing, according to Quest.¹

The company plans to make the test broadly available across its network, which includes approximately 2,000 US patient service centers. Samples will be analyzed at Quest’s laboratory in San Juan Capistrano, California.

Currently Quest provides a suite of lab-developed tests regulated under CLIA through its AD-Detect portfolio. The assays measure plasma levels of Aβ42 and 40, changes in the ratio of which indicate the risk potential of AD progression. "The Fujirebio test offering extends this portfolio to include an FDA-cleared option for use in specialized care settings," according to the company.¹

Diagnostics Should Match Therapeutics

“We are on the cusp of a new generation of therapies for Alzheimer’s disease, but the important role of diagnostics has been missing from the conversation,” Michael K. Racke, MD, medical director of neurology at Quest said in an earlier company statement.² “As new, efficacious therapies come to the forefront, the need for scalable, less invasive and more cost-effective diagnostics, including in primary care settings, will grow.”²

Physician sentiment appears to support the transition toward accessible blood-based screening. In a 2022 survey commissioned by Quest and conducted by The Harris Poll, 87% of physicians predicted blood tests for early AD risk would become the standard of care.² The survey, of 501 US primary care clinicians and more than 2,000 adults, also revealed that 94% of physicians consider blood tests more cost-effective than traditional methods such as PET imaging or lumbar puncture. However, 85% noted that the value of such tests would depend on broad insurance reimbursement.²

Currently, nearly 7 million Americans are living with Alzheimer’s disease, and that figure is projected to double by 2060. With no cure and limited treatment options, the demand for effective early detection tools, particularly ones that are scalable, accessible, and informative, continues to grow. Quest will present its full AD testing portfolio at the Alzheimer’s Association International Conference in Toronto from July 27 to 31, 2025.