Spear Bio Gets Breakthrough Status on Alzheimer's Test

FDA has granted Spear Bio a breakthrough device designation for its pTau 217 blood test for early diagnosis of Alzheimer's disease. The company says current diagnostic methods (e.g., PET scans and lumbar puncture cerebrospinal fluid analysis) are “invasive, costly, and logistically challenging… Spear Bio's pTau 217 plasma assay uses a wash-free workflow building on well-established and robust real-time PCR technology as the readout method.”

Spear says the test is intended to be used as an aid in diagnosing Alzheimer’s and helping to distinguish it from other neurological conditions. It uses the company’s proprietary Successive Proximity Extension Amplification Reaction (SPEAR) technology, and it “employs a unique two-factor authentication mechanism to minimize background from non-specific interactions, enabling accurate measurements of protein biomarkers at concentrations as low as 1 fg/mL from just 1 microliter of diluted sample.”