C2N Diagnostics’ study results show that blood biomarkers included in the Precivity blood test help increase the accuracy of amyloid positron emission tomography (PET) classification in pre-clinical Alzheimer’s disease.

The study was published in the Alzheimer’s Association journal, Alzheimer’s & Dementia. The study collected the biomarker data for the clinical trial for Eisai and Biogen’s Leqembi (lecanemab).

The biomarkers under evaluation included the well-established amyloid plaque biomarker, Aβ42/Aβ40, and tau protein biomarkers p-tau217, np-tau217, p-tau181, and np-tau181. Tau is a microtubule-associated protein that plays a key role in Alzheimer’s disease pathology.

There are currently 76 active Alzheimer’s in vitro diagnostic (IVD devices) in development, with ten devices currently undergoing clinical trials, as per GlobalData analysis.

“The cost and burden for researchers and research volunteers for studies into Alzheimer’s disease continues to rise. Any opportunity to streamline the recruitment and enrolment process is helpful given this scenario,” said C2N’s CEO and president Dr Joel Braunstein.

“The blood biomarkers with the highest performance in the study are the biomarkers highlighted in the Precivity blood tests, demonstrating the application of these biomarkers for important research purposes. In addition, healthcare specialists are currently using these biomarkers in our Precivity blood tests to help in the clinical evaluation of patients aged 55 years and older with concerns of cognitive impairment.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The study evaluated 1,080 baseline plasma samples from the participants who were recruited and screened for enrolment into the Phase III Leqembi trial (NCT04468659). Of all the participants, 340 had positive PET scan findings (defined as Centiloid scale > 20, a standardised amyloid PET measurement).

For the evaluated biomarker, plasma p-tau217/np-tau217 had the highest accuracy followed Aβ42/Aβ40 and p-tau181/np-tau181 for identifying amyloid PET status. Each of the biomarker ratios for the p-tau217, Aβ42, and p-tau181 were more robust in identifying amyloid PET status, compared to their individual absolute concentration values.

The researchers wrote that “including plasma p-tau217/np-tau217, along with Aβ42/Aβ40 in predictive algorithms, may streamline screening preclinical individuals into anti-amyloid clinical trials”.