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The firm said its test detects biomarkers inside monocyte blood cells that reflect the reduced clearance of amyloid-beta plaque that leads to Alzheimer's disease.
Life Genomics markets a noninvasive prenatal test for chromosomal abnormalities, a genetic disease carrier test, and an Alzheimer's disease risk test.
The Helix Laboratory Platform is the first whole-exome sequencing platform to receive do novo authorization by the agency and paves the way for others.
The firm said that a US FDA clearance would broaden the adoption of its growing portfolio of diagnostic assays for Alzheimer's disease.
The company also announced it has received approval from California to offer the test, which it launched in October as a lab-developed test, in that state.
The firm said that its test uses cerebral spinal fluid to produce a numerical ratio of β-Amyloid1-42/ β-Amyloid1-40, and runs on its fully automated Lumipulse G1200 instrument system.
The company plans to launch a test that leverages unfolded p53 as a biomarker for detection by mass spectrometry in a US-based CLIA-certified lab late next year.
The assay uses mass spec to measure levels of three proteins in blood and could provide a low cost, non-invasive alternative to existing Alzheimer's tests.
The two grants awarded will support DiamiR's development of microRNA diagnostics for mild cognitive impairment, Alzheimer's disease, and Rett syndrome.
Washington University researchers and a team including scientists from Eli Lilly independently identified a modified form of tau as a promising Alzheimer's marker.