C2N Diagnostics has officially published results from a study, which revealed that healthcare providers were able to enhance their ability in making Alzheimer’s disease (AD) probability judgments when they used the PrecivityAD2™ blood biomarker (BBM) tests
According to certain reports, the stated improvement would allow those healthcare professionals to more accurately detect amyloid plaques in the brain, a pathological hallmark of AD. Markedly enough, this change in clinician-reported probability of AD is also associated with meaningful improvements across downstream clinical care, including changes in plans for AD medications, as well as further brain amyloid testing.
Named as Clinical Utility of an Alzheimer’s Disease Blood Test Among Cognitively Impaired Patients: Results from the Quality Improvement PrecivityAD2 (QUIP II) Clinician Survey Study, the exercise in question discovered that, when deploying the PrecivityAD2 blood test, clinicians’ diagnostic confidence in AD rose from approximately 50-60% to over 90% among patients with a positive Amyloid Probability Score 2 (APS2) result.
Next up, it discovered that patients with a positive APS2 result (which would be consistent with an AD diagnosis) ended up boasting a 35% increase in AD medication prescribing, along with increased use of disease-modifying therapy lecanemab.
Another finding worth a mention here is rooted in the fact that patients with a negative APS2 (which would be inconsistent with an AD diagnosis) successfully realized what would be a 79% reduction in the need for AD medication prescribing and further brain amyloid testing.
“This research increases the growing body of evidence that demonstrates high clinical utility with blood biomarkers, which is bringing important advancements to the field. Too often, patients face a complex and delayed diagnostic journey when dealing with new cognitive concerns. High-performance testing with our PrecivityAD2 blood test has the potential to provide clarity and shorten that diagnostic journey, while significantly elevating healthcare quality,” said Dr. Joel Braunstein, CEO of C2N Diagnostics,
Among other things, we ought to mention how QUIP II study (NCT06025877) involved a total of eight academic and community-based practice sites, where 12 different memory specialists treated a total of 203 patients suffering from AD symptoms or other causes of cognitive decline.
The study also included a final analysis cohort of 28% patients who were identified by the clinician as typically under-represented Black, Hispanic, and Asian minorities. These patients had a median age of 74, with over half (53%) being female.
The recruited memory specialists received education and training on the intended use of this BBM test and the APS2 result, which combines the plasma Aβ42/Aβ40 ratio with ptau217/np-tau217 ratio (%p-tau217) measurements in a statistical algorithm to reach upon a score which, on its part, relays the likelihood of brain amyloid plaques.
Once they went through the training, each clinician then completed a survey which was baked into a bigger HIPAA (Health Insurance Portability and Accountability Act) compliant survey system. The study would go onto collect clinician feedback concerning pre- and post-BBM test diagnostic certainty, and pre- and post-BBM test patient management plans.
Interestingly, the QUIP II study treads up a long distance to validate findings of the original QUIP I study, where researchers examined the PrecivityAD® blood test with 43 memory care specialists caring for 366 patients.
In case you weren’t aware QUIP I was also one of the first clinical utility studies to analyze the real-world impact of a blood biomarker test in facilitating AD diagnosis and management. You see, this study saw PrecivityAD test providing clinically informative results in approximately 85% of cases. It further enabled clinicians to more confidently rule in or rule out a diagnosis of clinical AD.
“Patients and families have greatly benefited from healthcare providers having access to C2N’s PrecivityAD2 blood test to help diagnose Alzheimer’s disease. The test was straightforward to incorporate into my clinical practice. The overall outcome has been clinically meaningful changes in decision-making around AD diagnostic certainty, drug therapy management and additional brain amyloid evaluation among patients evaluated for cognitive impairment. This all increases our ability to develop diagnostic certainty and impact clinical management in patients,” said Dr. Robert M. Carlile, one of the study investigators based at Palmetto Primary Care Physicians in Summerville, S.C.
