Food and Drug Administration has a green experimental company in Japan Fujirebio to start marketing blood test to help doctors diagnose Alzheimer’s disease In some patients, cleansing the way for the widest availability of the approach.
The Fujirebio test works with the company’s Lumipulse equipment, which the company says is already “widely available in clinical laboratories” around the United States that describes Fujirebio Lumipulse as a “fully automatic” system that can do 120 hour of blood on the blood and other samples.
The test works by measuring two types of proteins in the blood associated with whether the brain has been built Amyloid paintingsWhich research was associated with Alzheimer’s disease.
“Today’s statement is an important step to diagnose Alzheimer’s disease, which makes it easier and perhaps available to patients earlier in the disease,” said Dr. Michel Tarvar, Director of the Food and Drug Administration Center for Radio IDs, in A. statement.
All people should not take a new Fujripio test. The FDA (FDA) says it is “intended for patients who provide specialized care with signs and symptoms of cognitive decline” and is limited for adults between the ages of 55 years and over.
The agency says that Fujeribio provided data from a study that included 499 samples of blood plasma from adults who suffer from cognitive impairment, and compare the results of the blood test with alternative methods that doctors can verify from head -brown amyloid paintings: brain tests and forklined fluid tests.
In 91.7 % of patients who studied who tested positively in their blood, they also had amyloid paintings that appeared in the brain examination or spinal fluid test. The share of the negative results that match these other tests was also high, by 97.3 % of patients.
“We have designed a plasma test from Lumipulse G Ptau 217/β-ALYOID 1-42 to help doctors and patients with signs and symptoms of cognitive retreat to diagnose an early advertisement when the interventions are more effective”, “Fujirebio He said In a release last year, after submitting his organizational file to the FDA for the test.
Exit from the Food and Drug Administration comes on the marketing of Fujirebio Test after years that other blood tests for Alzheimer’s disease have already started sales, without this type of approval from the agency.
Experts were cautious about some Previous blood tests To diagnose Alzheimer’s disease, which was sold under a different Systems That governs the tests created by individual laboratories that test a high complexity.
Last year, according to the Biden Administration, the agency was cultivate Cut these “advanced laboratory tests” that are sold to diagnose Alzheimer’s and other health issues, which FDA officials have argued that they should undergo strict federal supervision.
“The FDA approach (FDA) was developed half a century ago when the tests were conducted and used in simple individual laboratories in general, and often made to address local individual needs, most of which are made in small sizes,” were federal health officials. He said In January.
In defense of this step, the Food and Drug Administration quotable An example of the previous submission of a failure to obtain the agency’s marketing license to help diagnose Alzheimer’s disease, but it was still able to sell it in the American market by the laboratory.
The agency said: “Many treatable cases have symptoms similar to AD or any other form of dementia. Without sufficient information to prove adequate health verification, the performance of the test is unknown, which may expose patients to the risk of harm due to inaccurate results.”
A lawsuit supported by the American Clinical Laboratory Association successfully challenge The New Food and Drug Administration base has developed on laboratory tests, persuading a federal judge in Texas earlier this year to launch the list.
The group said after the verdict in March: “This is a victory that protects the patient’s access to test services that need money and remove the exhausting regulations that were undermining the clinical laboratory system in this country.”
