Amprion

Amprion is a life sciences and diagnostics company focused on advancing precision medicine for neurodegenerative disorders. The company was co-founded by Claudio Soto, Ph.D., and Russell Lebovitz, M.D., Ph.D. Dr. Soto's groundbreaking research into detecting misfolded proteins forms the scientific foundation of the company. Dr. Lebovitz, the CEO, brings extensive experience in managing diagnostic and biotech companies, from research and development to commercial product launches. His background includes work as a senior scientist, research physician, and faculty member at Baylor College of Medicine and the Fox Chase Cancer Center.

Amprion's core business revolves around its proprietary seed amplification assay (SAA) technology. This technology is the basis for its flagship product, the SAAmplify™-ɑSYN Biomarker Test, a laboratory-developed test (LDT) performed on cerebrospinal fluid (CSF). The test is designed to detect the presence of misfolded alpha-synuclein protein aggregates, which are pathological hallmarks of synucleinopathies. This provides a biological basis for diagnosis, a significant step forward from traditional methods that rely heavily on symptom observation, which can be incorrect up to 44% of the time. The company operates a CLIA-certified and CAP-accredited laboratory in San Diego where all tests are processed.

The primary clients for Amprion's testing services are clinicians, specifically neurologists and specialists in cognitive and movement disorders, who use the test to aid in the diagnosis of diseases like Parkinson’s disease (PD), Lewy body dementia (LBD), and Alzheimer's disease with Lewy body variant. By identifying the underlying pathology with high accuracy, the test helps physicians make more definitive diagnoses. In addition to clinicians, Amprion collaborates with biopharmaceutical companies to support clinical trials by providing biomarker detection that can help in patient stratification, endpoint selection, and monitoring treatment efficacy. The FDA granted the test a Breakthrough Device Designation in 2019, and it became commercially available in 2021.

Keywords: neurodegenerative disorders, diagnostics, precision medicine, Parkinson's disease, Lewy body dementia, alpha-synuclein, seed amplification assay, biomarker testing, cerebrospinal fluid analysis, protein misfolding, clinical laboratory services, diagnostic technology, synucleinopathies, neurodiagnostics, LDT, CLIA certified lab, CAP accredited, biopharmaceutical partnerships, clinical trial support, early disease detection