Quest to offer FDA-cleared blood test for Alzheimer’s disease

SECAUCUS, N.J. - Quest Diagnostics (NYSE:DGX), a prominent player in the Healthcare Providers & Services industry with a market capitalization of $19.26 billion, announced Wednesday it plans to offer the first FDA-cleared blood-based test for Alzheimer’s disease later this summer. According to InvestingPro data, the company maintains strong financial health with consistent profitability and revenue exceeding $10 billion in the last twelve months.

The Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio test, developed by Fujirebio, is designed to aid in identifying patients with amyloid pathology associated with Alzheimer’s disease. The test is intended for adults aged 50 and older with signs of cognitive decline in specialized care settings. This development aligns with Quest’s growth strategy, which has helped drive a 9.4% revenue increase over the past year.

According to a press release statement, the test demonstrated a positive predictive value of 92% and a negative predictive value of 97% in a clinical study of 499 patients, though 20% of results were uncertain and required additional testing.

"Blood-based testing can be less invasive and more convenient than traditional test methods," said Kathleen Valentine, Vice President and General Manager of Neurology at Quest Diagnostics.

The Fujirebio test will join Quest’s existing AD-Detectâ„¢ portfolio of laboratory-developed blood tests for assessing cognitive impairment. Testing will be conducted at Quest’s laboratory in San Juan Capistrano, California, with blood draws available at approximately 8,000 patient access points nationwide.

Traditional Alzheimer’s diagnostic methods like amyloid PET imaging and cerebrospinal fluid testing are more expensive and invasive than blood tests.

Nearly 7 million Americans have Alzheimer’s disease, with projections reaching 14 million by 2060. Between 12-18% of adults over age 60 live with mild cognitive impairment, a potential early sign of the disease.

Quest plans to showcase its neurological testing innovations at the Alzheimer’s Association International Conference in Toronto from July 27-31.

In other recent news, Quest Diagnostics reported impressive Q1 2025 earnings, exceeding market expectations with an adjusted EPS of $2.21, surpassing the forecasted $2.16. The company also reported a revenue of $2.65 billion, slightly above the anticipated $2.64 billion, marking a 12.1% year-over-year increase. Fitch Ratings upgraded Quest Diagnostics’ Long-Term Issuer Default Rating to ’BBB+’ with a stable outlook, citing the company’s strong operational performance and steady demand for clinical testing. Additionally, JPMorgan raised its price target for Quest Diagnostics from $180 to $190, maintaining a Neutral rating, reflecting confidence in the company’s stability amidst market volatility.

The company’s shareholders recently elected directors and approved executive compensation at the 2025 Annual Meeting, demonstrating strong shareholder confidence. PricewaterhouseCoopers was ratified as the independent auditor for 2025. However, a proposal regarding the ability to call a special meeting was not approved by the shareholders. Fitch anticipates Quest Diagnostics’ mergers and acquisitions activities to align with historical levels, and the company is expected to allocate significant funds towards M&A and shareholder returns between 2025 and 2028.

Quest Diagnostics reaffirmed its full-year 2025 revenue guidance of $10.7 to $10.85 billion and adjusted EPS guidance of $9.55 to $9.80. The company continues to focus on strategic initiatives, including the Invigorate cost-saving program, and expects to maintain a competitive edge through advanced diagnostic tests. These developments reflect a robust operational and financial outlook for Quest Diagnostics, supported by strategic growth initiatives and a strong market position.

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