Quest Diagnostics Launches FDA-Cleared Blood Test for Early Alzheimer's Detection

Quest Diagnostics Launches Innovative Blood Test for Alzheimer's



Quest Diagnostics, a prominent leader in diagnostic information services, is taking a significant step forward in the battle against Alzheimer's disease. The company has announced its plans to introduce a groundbreaking blood test, developed in collaboration with Fujirebio, that has recently received clearance from the U.S. Food and Drug Administration (FDA). This test, known as the Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test, is designed to support the identification of patients exhibiting amyloid pathology, which is closely linked to Alzheimer's disease.

Key Features of the New Test


The launch of this test marks a pivotal moment as it is the first FDA-cleared blood-based IVD test aimed at assisting in the clinical evaluation of Alzheimer's disease in adult patients aged 50 years and older who show signs of cognitive decline. Quest Diagnostics plans to provide access to this vital tool to physicians and biopharmaceutical allies later this summer, enhancing the existing AD-Detect™ portfolio, which already includes advanced lab-developed blood tests regulated under CLIA.

According to Kathleen Valentine, Vice President and General Manager of Neurology at Quest Diagnostics, Our goal is to advance access to quality and innovative blood-based tests for Alzheimer's disease. 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's disease. This sentiment emphasizes the importance of accessible and less invasive diagnostic tools for conditions as critical as Alzheimer's.

Advantages of Blood-Based Testing


Blood-based testing presents a multitude of advantages over more traditional methods such as amyloid PET imaging or cerebrospinal fluid testing, which tend to be significantly more invasive and expensive. Patients can provide a blood sample at one of Quest's approximately 8,000 patient access points across its network, including about 2,000 patient service centers located in the U.S. Once collected, the samples are sent to Quest’s state-of-the-art laboratory in San Juan Capistrano, California, for testing.

The promising results of the clinical study involving 499 patients demonstrate the efficacy of the new FDA-cleared test, which showed a positive predictive value (PPV) of 92% and a negative predictive value (NPV) of 97%. The study highlights the pressing need for further testing in about 20% of patients who had ambiguous results regarding their amyloid pathology diagnosis. These high percentages reflect the test's reliability and potential for aiding in earlier diagnoses, which is crucial for effective intervention and treatment.

Addressing the Alzheimer's Epidemic


The urgency of this initiative comes against the backdrop of the alarming rise in Alzheimer's cases. Currently, nearly 7 million Americans are diagnosed with the disease, a figure expected to double to 14 million by 2060. About 12-18% of adults over 60 are living with mild cognitive impairment, one of the first signs of Alzheimer's disease. The medical community expresses optimism, with 77% of physicians believing that new therapies could transform the condition into a manageable disease. Furthermore, a substantial 94% of healthcare professionals argue that blood tests would provide a more cost-effective solution than invasive testing methods.

In an age where swift and accurate diagnostics are more important than ever, Quest Diagnostics remains dedicated to enhancing the landscape of advanced diagnostics for Alzheimer's and other neurological disorders. Their commitment is visible not just in the technology they adopt but also in their mission to deliver actionable insights that empower patients and healthcare providers alike.

Looking Ahead


As part of its ongoing effort to combat Alzheimer's disease, Quest will showcase this innovative testing option at the upcoming Alzheimer's Association International Conference (AAIC) in Toronto from July 27-31. This event offers a platform for further discussion on the evolution of brain health interventions and the pressing need for early diagnostics.

For more information on this innovative blood test and other diagnostics offered by Quest Diagnostics, visit www.QuestForTheCure.com. Quest Diagnostics strives to advance healthcare by continuously prioritizing innovation and accessibility in diagnostics.

Topics Health)

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