With Eisai and Biogen’s Leqembi treatment for Alzheimer’s disease recently receiving full FDA approval, Quanterix has launched a prescription test, LucentAD, for the p-Tau 181 protein. The test will be used to support physicians in diagnosing patients with early symptoms and assessing if drug therapy is warranted. The test has also recently been shown to correlate with reduction in amyloid load in the brains of amyloid patients on anti-amyloid drug therapies. Performed on its SIMOA platform, LucentAD is a lab developed test (LDT), i.e., not approved by FDA’s CDRH division. Quanterix is offering the assay through its just launched Lucent Diagnostics lab, which operates under CLIA regulations in the US.
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