Researchers have determined that healthcare providers increased their ability to make Alzheimer’s disease (AD) probability judgments on their patients when they used the PrecivityAD2™ blood biomarker (BBM) tests from C2N Diagnostics, LLC, which aid them in the detection of amyloid plaques in the brain, a pathological hallmark of AD. This change in clinician-reported probability of AD is also associated with meaningful improvements in downstream clinical care, including changes in plans for AD medications as well as additional brain amyloid testing.

Dr. Joel Braunstein, CEO of C2N Diagnostics, says, “This research increases the growing body of evidence that demonstrates high clinical utility with blood biomarkers, which is bringing important advancements to the field.”

This research, Clinical Utility of an Alzheimer’s Disease Blood Test Among Cognitively Impaired Patients: Results from the Quality Improvement PrecivityAD2 (QUIP II) Clinician Survey Study, was published in the peer-reviewed Diagnostics journal. The research found:

  • With 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, guiding management decisions.
  • Patients with a positive APS2 result (which would be consistent with an AD diagnosis) had a 35% increase in AD medication prescribing as well as increased use of disease-modifying therapy lecanemab.
  • Patients with a negative APS2 (which would be inconsistent with an AD diagnosis) had an over 70% reduction in AD medication prescribing and additional brain amyloid testing.
  • Clinicians prescribed the blood test in high accordance with its intended use criteria.

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The QUIP II study (NCT06025877) involved eight academic and community-based practice sites, and 12 memory specialists who treated a total of 203 patients presenting with AD symptoms or other causes of cognitive decline. It included a final analysis cohort of 28% patients that were identified by the clinician as typically under-represented Black, Hispanic and Asian minorities; they had a median age of 74 and over half (53%) were female.

The memory specialists received education and training on the intended use of this BBM test as well as the APS2 result, which combines the plasma Aβ42/Aβ40 ratio and the ptau217/np-tau217 ratio (%p-tau217) measurements in a statistical algorithm to yield the score that informs on the likelihood of brain amyloid plaques. Each clinician then completed a survey that was built within a HIPAA (Health Insurance Portability and Accountability Act) compliant survey system. The survey collected clinician feedback concerning pre- and post-BBM test diagnostic certainty, as well as pre- and post-BBM test patient management plans, including medication prescribing and additional brain amyloid evaluation.

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Dr. Robert M. Carlile, one of the study investigators based at Palmetto Primary Care Physicians in Summerville, S.C., says, “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.”

Dr. Joel Braunstein, CEO of C2N Diagnostics, says, “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.”

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Source – businesswire