CONTACT US   |  (864) 397-5101

Roche receives FDA breakthrough device designation for Alzheimer’s disease blood test

Roche has announced that its blood test, Elecsys pTau217, has been granted breakthrough device designation from the US Food and Drug Administration for earlier diagnosis of Alzheimer’s disease (AD).

The blood test, which is being developed in collaboration with Eli Lilly, works to identify the presence or absence of amyloid pathology in individuals, a pathological feature of the neurodegenerative condition.

AD is a progressive form of dementia that slowly destroys an individual’s memory and thinking skills.

According to the Alzheimer’s Society, around 55 million people are living with dementia globally, which is estimated to rise to 139 million by 2050.

In previous studies, pTau217 has shown the ability to distinguish AD from other neurodegenerative disorders and has demonstrated a strong performance relative to other biomarkers.

To be used in the diagnostic pathway with other clinical information, a positive result of the Elecsys pTau217 test indicates a high likelihood of having a positive amyloid positron emission tomography (PET)/cerebrospinal fluid (CSF) result.

Both companies believe that the plasma biomarker test could play a significant role in improving access to early and accurate AD diagnosis, following approval.

If successful, the test will support healthcare providers in identifying amyloid pathology in individuals and help ensure that they are able to receive the appropriate care, including through participating in clinical trials or by gaining access to approved disease-modifying therapies.

“There is a critical role for diagnostics to play in addressing this global health challenge,” said Matt Sause, chief executive officer of Roche Diagnostics.

“We believe pTau217 is going to be crucial in the diagnosis of AD… [and] we plan to leverage our installed base of diagnostic systems… to ensure we are able to create access to this test for those who need it the most,” Sause added.

Anne White, executive vice president of Eli Lilly and president of Lilly Neuroscience, said: “We’re excited to help meet the growing need for additional diagnostic tools to enable a timely and accurate diagnosis for people with AD.”

Roche announced its partnership with Eli Lilly in March 2023 to develop the blood test for AD to help streamline the journey to diagnosis for more patients.

Join now to enjoy expanded member benefits!

Enjoy exclusive member content, special events, savings, networking and more

Tamia Sumpter

Tamia is a driven senior undergraduate Bioengineering student currently enrolled at Clemson University. With a strong foundation in her field, she has honed her skills through hands-on experience in research and development at Eli Lilly & Company. During her time in the ADME department, Tamia contributed significantly by working on siRNAs and their applications in finding In Vitro-In Vivo Correlation (IVIVC). Looking ahead, Tamia has set her sights on a promising career in law. She aspires to specialize in Intellectual Property Law, with a particular focus on serving as in-house counsel for leading medical device or pharmaceutical companies. Her enthusiasm for this role is palpable as she prepares to embark on her legal journey! She is also a proud member of the Omicron Phi chapter of Delta Sigma Theta Sorority, Inc., PEER Mentor for Clemson PEER/WiSE, and currently serves as the President of Clemson Bioengineering Organization (CBO). With her unique blend of scientific knowledge and legal interests, Tamia is poised to make a meaningful impact in the healthcare and life sciences industries.