Fujirebio's Alzheimer's blood test, cleared by the FDA, up for grabs in new venture
In a significant breakthrough for Alzheimer's disease diagnosis, Quest Diagnostics and Fujirebio Diagnostics are leading the way with innovative blood tests. These tests, aimed at identifying patients who may require further investigation, are set to revolutionise the diagnostic process.
Jim Davis, CEO of Quest Diagnostics, recently discussed the company's test at a William Blair event in June. Quest Diagnostics launched a laboratory-developed test for similar biomarkers in April, and they plan to offer laboratory testing based on Fujirebio Diagnostics' FDA-authorized Alzheimer's disease blood test this summer.
Quest Diagnostics' AD-Detect panel using beta-amyloid 42/40 and pTau217 provides a likelihood score to classify patients by probability of Alzheimer's, achieving sensitivity and specificity levels around or above 90% in cohorts with roughly 50% PET amyloid prevalence. This corresponds to high positive predictive value (PPV) and negative predictive value (NPV).
On the other hand, Fujirebio Diagnostics' Lumipulse G pTau217/β-Amyloid 1-42 test is the first FDA-cleared blood biomarker test to aid Alzheimer’s diagnosis. It is designed for symptomatic adults 50 years and older in specialized care. Fujirebio validated the test in a study of 499 people, linking the IVD to positive and negative predictive values of 92% and 97%, respectively, with less than 20% of people receiving indeterminate results.
The advantages of blood tests have spurred interest in using them to identify patients who should have a PET scan to check for amyloid plaques in the brain. Davis believes testing for a combination of beta-amyloid and tau biomarkers could provide an earlier view of early onset Alzheimer's.
Primary care physicians are using Quest's LDT to determine whether patients need referral to a neurologist, addressing the current problem of getting a referral into a neurologist. Davis stated that the ability for primary care physicians to run a test to determine who needs referral will be a "huge help to the overall health system." Ultimately, blood tests could eliminate the need for PET scans in some patients.
Quest's test "over time will largely replace PET-CT as the primary diagnostic tool for the detection of Alzheimer's," according to Davis. The uptake of Quest's LDT is "really starting to take off." Quest Diagnostics plans to offer Fujirebio’s FDA-cleared test alongside their existing lab-developed tests, expanding options with an FDA-cleared IVD test that complements their CLIA-regulated AD-Detect suite.
In sum, both Quest’s Laboratory-Developed Test and Fujirebio’s FDA-cleared test deliver similarly strong predictive performance (PPV and NPV typically around or above 90%), with Quest’s test providing a probability score and Fujirebio’s test offering an FDA-cleared commercial option. The clinical lab plans to make Fujirebio's Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test available for use by physicians and researchers this summer.
The increasing value of early diagnosis as companies develop medicines effective in early stages of the disease further underscores the importance of these blood tests. With their non-invasive and scalable nature, blood tests could make Alzheimer's diagnosis more accessible and efficient, offering hope for those affected by this debilitating disease.
[1] Quest Diagnostics press release, April 2023 [2] Fujirebio Diagnostics press release, May 2023
- In a notable advancement for Alzheimer's disease diagnostics, Quest Diagnostics and Fujirebio Diagnostics are spearheading novel blood tests, revolutionizing the diagnostic process.
- At a William Blair event in June, Jim Davis, CEO of Quest Diagnostics, discussed their blood test, which launched in April and will offer laboratory testing based on Fujirebio's FDA-authorized Alzheimer's disease blood test this summer.
- Quest Diagnostics' AD-Detect panel, employing beta-amyloid 42/40 and pTau217, offers a likelihood score for classifying patients by Alzheimer's probability, providing sensitivity and specificity levels around or above 90% in cohorts with roughly 50% PET amyloid prevalence.
- Fujirebio Diagnostics' Lumipulse G pTau217/β-Amyloid 1-42 test is the first FDA-cleared blood biomarker test to aid Alzheimer’s diagnosis, and it is designed for symptomatic adults aged 50 and older in specialized care.
- These blood tests have sparked interest in using them to identify patients who might require a PET scan to check for amyloid plaques in the brain, with Davis suggesting that testing for a combination of beta-amyloid and tau biomarkers could offer an earlier view of early onset Alzheimer's.
- Primary care physicians are now using Quest's Laboratory-Developed Test to determine whether patients require a referral to a neurologist, addressing the current challenge of obtaining a neurologist referral.
- With the adoption of Quest's LDT "really starting to take off," Quest Diagnostics plans to offer Fujirebio's FDA-cleared test alongside their existing lab-developed tests, broadening options with an FDA-cleared IVD test that complements their CLIA-regulated AD-Detect suite. These blood tests, through their non-invasive and scalable nature, could bring more accessibility and efficiency to Alzheimer's disease diagnoses, offering hope for those affected by this debilitating condition. [References: Quest Diagnostics press release, April 2023; Fujirebio Diagnostics press release, May 2023]
