This audio is automatically generated. feedback.
Biomarkers are increasingly Promoting pharmaceutical research Advances in precision medicine. But not all fields are on equal footing. Doctors are increasingly using established cardiac biomarkers, e.g. TroponinHowever, when it comes to brain-related disorders, the answers aren’t always so clear-cut.
“We’ve had good diagnostic tests and very effective drugs for 30 years[in cardiology]but in neurology, and particularly in Alzheimer’s, drugs are only just starting to become widespread,” said Bruce Jordan, international business leader for personalized medicine solutions in neurology and general medicine at Roche. “There’s a big gap in the market worldwide in terms of the availability of good, reliable biomarkers that can run on in vitro diagnostic analyzers.”
The brain’s complexity has hindered progress, but researchers in the field have finally made much-needed progress in recent years.
Testing Improvements
Roche is working to advance the development of biomarker tests to diagnose and treat Alzheimer’s and other brain diseases.
“The science is moving very quickly, but we have a lot of catching up to do,” Jordan said.
The FDA granted breakthrough device designation in April to Roche’s blood test for Alzheimer’s disease research. Elecsys pTau217 AssayThe test, developed in partnership with Eli Lilly, detects fragments of the protein tau, a biomarker for Alzheimer’s, in plasma. A positive result indicates a patient’s brain is likely to have a buildup of harmful proteins that are characteristic of the degenerative brain disease. The test could help distinguish between Alzheimer’s patients and those with other types of dementia and identify the disease at an earlier stage, when drugs such as Lukembi would be most effective.
“Only people who have amyloid pathology and have been diagnosed with Alzheimer’s disease can really benefit from these drugs,” said Margherita Carboni, head of neurology indications at Roche.
“I believe we are at the beginning of an entirely new era in neurodegenerative diseases.”
Bruce Jordan
Roche, an international business leader in personalized healthcare solutions in neurology and integrated medicine
Currently, Alzheimer’s disease is often diagnosed at a late stage based on symptoms and other assessments. Approximately 23% of Alzheimer’s patients are misdiagnosed. According to Roche.
In addition to the Elecsys pTau217 test, Roche has developed other biomarker tests, including two cerebrospinal fluid tests for Alzheimer’s disease. FDA ApprovedThe FDA also: Third blood test It will receive breakthrough device designation in 2022.
Alzheimer’s isn’t the only disease getting attention. Parkinson’s disease researchers recently Victory was won Identify important biomarkers search For many.
Roche too Neuro Toolkit The project was originally a coalition aimed at identifying biomarkers for Alzheimer’s disease, but the focus has now expanded, Jordan said.
“We quickly realized that the needs of many neurodegenerative diseases are very similar,” he said. “Whether it’s multiple sclerosis, Parkinson’s, Alzheimer’s or ALS (amyotrophic lateral sclerosis), the brain is a difficult organ to access and understand.”
Progress towards identifying biomarkers may facilitate advances in better treatments and outcomes for people with these diseases.
“I think we’re at the beginning of a whole new era in neurodegenerative disease,” Jordan said, “and I believe we’re just at the beginning and have a long, long way to go with the therapies that are coming.”
