Quest Diagnostics Adds p-tau217 Blood Biomarker Testing to Suite of Services Designed to Assess Risk and Help Aid Diagnosis of Alzheimer's Disease

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Quest Diagnostics announces the addition of a new blood biomarker test for phosphorylated tau 217 (p-tau217) to its AD-Detect™ portfolio, aimed at assessing the risk and aiding in the early diagnosis of Alzheimer's Disease. The test complements existing blood tests for AD biomarkers, offering patients and providers a comprehensive approach to brain health evaluation.

Positive

• Quest Diagnostics introduces a new blood biomarker test for p-tau217, associated with Alzheimer's Disease, to its AD-Detect™ portfolio.
• The test is supported by research as useful for early diagnosis of AD and complements existing blood tests for AD biomarkers.
• Patients can access the test through Quest's 2,000 patient service centers in the United States, starting from April 26, 2024.
• The addition of p-tau217 enhances Quest's neurology testing portfolio, providing insights for risk assessment and early diagnosis of AD.
• Quest's focus on expanding access to innovative dementia diagnostic solutions includes blood tests, cerebrospinal fluid tests, and genetic risk assessments.
• The availability of p-tau217 testing signifies Quest's commitment to helping individuals better understand their potential risk of Alzheimer's Disease.

Negative

• None.

Medical Research Analyst

Quest Diagnostics' inclusion of p-tau217 in their battery of Alzheimer's diagnostic tests aligns with the evolving landscape of neurodegenerative disease management. The medical community has recognized the need for less invasive, more accessible diagnostic tools and adding a blood biomarker test for p-tau217, which has been indicated in research to be potentially useful for early detection of Alzheimer's, is a step in that direction. Furthermore, the comparison between the cost and invasiveness of amyloid PET imaging and the blood tests offered by Quest suggests a competitive advantage in terms of patient accessibility and comfort. It's vital to consider the clinical validation of these tests and their integration into current diagnostic protocols, as well as the implications for therapeutic development and personalized medicine approaches.

Healthcare Industry Analyst

From an industry perspective, this move may underscore Quest's strategic positioning within the diagnostics segment, particularly for chronic conditions with significant market demand like Alzheimer's. The prevalence of Alzheimer’s Disease is increasing and so is the urgency for reliable, scalable diagnostic methods. Quest's expansion of their AD-Detect™ portfolio could potentially meet this growing need and it's likely to be well-received by the medical community. By offering a suite of tests including p-tau217, Quest may see an increase in service utilization, which could lead to revenue growth. The long-term implications could also entail strong partnerships with pharmaceutical companies seeking diagnostic tools for clinical trials and treatment monitoring.

Financial Analyst

From a financial standpoint, the launch of a new blood test by Quest Diagnostics is a move that can create multiple revenue streams. Quest's stockholders might anticipate increased market share in neurology diagnostics, an area that is experiencing a surge in demand due to demographic trends. For investors, the pertinent factors to observe would be the adoption rate of this new test by healthcare providers, its margin contribution compared to traditional tests and the potential for integration with other diagnostic and treatment services. Monitoring Quest's operational efficiencies in scaling these services will be telling of the financial impact of this launch on the company's bottom line.

Company's AD-Detect™ Portfolio Offers AB 42/40 and Other Plasma Biomarker Testing, Alongside Traditional Cerebrospinal Fluid and Genetic Tests, to Provide Robust Offering in Brain Health

SECAUCUS, N.J., April 22, 2024 /PRNewswire/ -- Quest Diagnostics (NYSE: DGX), a leader in diagnostic information services, today announced the launch of a new blood biomarker test for phosphorylated tau 217, or p-tau217. P-tau217 is a biomarker associated with Alzheimer's Disease (AD), supported by research as useful for an early diagnosis of AD.

The test is the latest addition to the AD-Detect™ portfolio of blood tests for assessing the risk of Alzheimer's Disease, which also includes testing for an array of AD biomarkers, including p-tau181 and amyloid beta (AB) proteins, as well as Apolipoprotein E (ApoE) isoform and plasma testing, for patients with cognitive impairment. With a physician's test order, patients may provide a blood draw for testing from any of Quest's 2,000 patient service centers in the United States. The test is expected to be available for ordering on April 26, 2024.

Quest Diagnostics continually seeks to expand access for patients and providers to innovations in the field of dementia, including AD, through advanced diagnostic solutions. The addition of p-tau217 to Quest's existing portfolio of neurology testing supports a comprehensive offering, including not only the groundbreaking use of blood tests to evaluate risk of AD, but also cerebrospinal fluid (CSF) tests to help providers assess amyloid beta 42, tau and ApoE genetic risk status.

"By expanding our test availability to include p-tau217 and other blood-based biomarkers, Quest has invested significantly in providing insights to aid risk assessment and early diagnosis of Alzheimer's Disease," said Kathleen Valentine, Vice President and General Manager, Neurology, Quest Diagnostics. "We know diagnosing AD is challenging, and believe our AD Detect™ services can help individuals better understand their possible risk."

While amyloid PET imaging is an established method for aiding the diagnosis of AD, it is significantly more expensive, invasive and specialist-dependent than blood tests. Through its proprietary AD-Detect™ line of blood tests, Quest enables access for patients and providers to quality laboratory innovations for Alzheimer's Disease on a broad national scale.

"Testing to assess Alzheimer's disease has changed rapidly in the last few years, and we expect this area to continue evolving," said Michael Racke, MD, Medical Director of Neurology at Quest Diagnostics. "The future of assessing risk or diagnosing AD will likely include a variety of testing modalities and biomarkers, including blood, to help clinicians identify patients in the early stages of disease progression. When examined with cognitive test results, p-tau217 has the potential to aid diagnosis, and will play a valuable role in assessing patients with cognitive impairment, especially when combined with other tests."

Nearly 7 million Americans have Alzheimer's, the most prevalent dementia, a number projected to reach 14 million by 2060. New blood tests offer the potential for primary care physicians as well as specialists to identify people at risk for Alzheimer's Disease even before symptoms manifest. Seventy-seven percent of physicians say new therapies will transform Alzheimer's into a chronic, manageable disease, according to a special report from Quest based on a survey by Harris Poll.

A leader in neurology, Quest Diagnostics is committed to developing innovative laboratory services to aid in evaluating patient risk of Alzheimer's Disease and other dementias. Through its courier network and 2,000 patient service centers in the U.S, Quest is uniquely positioned to collect blood specimens, with a physician's order, and provide advanced laboratory testing on a national scale.

Recently published research in the Journal of Investigative Medicine, Frontiers in Neurology and Alzheimer's & Dementia demonstrates the value of the company's AD-Detect™ amyloid beta test in aiding risk assessment of AD. The company also continues to explore the potential of other biomarkers for assessing AD risk that may complement its existing portfolio. For more information, visit www.QuestForTheCure.com.

About Quest Diagnostics
Quest Diagnostics works across the healthcare ecosystem to create a healthier world, one life at a time. We provide diagnostic insights from the results of our laboratory testing to empower people, physicians and organizations to take action to improve health outcomes. Derived from one of the world's largest databases of de-identifiable clinical lab results, Quest's diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve healthcare management. Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our nearly 50,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives and create a healthier world. www.QuestDiagnostics.com.

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SOURCE Quest Diagnostics

FAQ

What is the new blood biomarker test added to Quest Diagnostics' AD-Detect™ portfolio?

Quest Diagnostics has added a new blood biomarker test for phosphorylated tau 217 (p-tau217) to its AD-Detect™ portfolio, aimed at assessing the risk and aiding in the early diagnosis of Alzheimer's Disease.

Where can patients access the new blood biomarker test for p-tau217?

Patients can provide a blood draw for testing from any of Quest's 2,000 patient service centers in the United States.

When will the new blood biomarker test for p-tau217 be available for ordering?

The test is expected to be available for ordering on April 26, 2024.

What other tests are included in Quest Diagnostics' AD-Detect™ portfolio for Alzheimer's Disease?

The AD-Detect™ portfolio includes testing for an array of AD biomarkers, such as p-tau181, amyloid beta (AB) proteins, Apolipoprotein E (ApoE) isoform, and plasma testing, for patients with cognitive impairment.

Who is Kathleen Valentine and what is her role at Quest Diagnostics?

Kathleen Valentine is the Vice President and General Manager, Neurology, at Quest Diagnostics. She mentions that the addition of p-tau217 and other blood-based biomarkers aims to provide insights to aid risk assessment and early diagnosis of Alzheimer's Disease.