𝐈𝐧 𝐓𝐞𝐧𝐧𝐞𝐬𝐬𝐞𝐞, 𝟏 𝐢𝐧 𝟒 𝐩𝐞𝐨𝐩𝐥𝐞 𝐡𝐚𝐬 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐛𝐭 𝐢𝐧 𝐜𝐨𝐥𝐥𝐞𝐜𝐭𝐢𝐨𝐧𝐬. 𝐓𝐡𝐚𝐭’𝐬 𝐧𝐨𝐭 𝐣𝐮𝐬𝐭 𝐚 𝐡𝐞𝐚𝐥𝐭𝐡 𝐬𝐭𝐚𝐭𝐢𝐬𝐭𝐢𝐜—𝐢𝐭’𝐬 𝐚 𝐩𝐨𝐰𝐞𝐫𝐟𝐮𝐥 𝐞𝐜𝐨𝐧𝐨𝐦𝐢𝐜 𝐢𝐧𝐝𝐢𝐜𝐚𝐭𝐨𝐫. 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐛𝐭 𝐝𝐨𝐞𝐬𝐧’𝐭 𝐣𝐮𝐬𝐭 𝐫𝐞𝐟𝐥𝐞𝐜𝐭 𝐚𝐧 𝐢𝐥𝐥𝐧𝐞𝐬𝐬 𝐨𝐫 𝐢𝐧𝐣𝐮𝐫𝐲; 𝐢𝐭 𝐫𝐞𝐟𝐥𝐞𝐜𝐭𝐬 𝐚 𝐬𝐲𝐬𝐭𝐞𝐦 𝐭𝐡𝐚𝐭 𝐭𝐫𝐞𝐚𝐭𝐬 𝐡𝐮𝐦𝐚𝐧 𝐡𝐞𝐚𝐥𝐭𝐡 𝐚𝐬 𝐚 𝐬𝐨𝐮𝐫𝐜𝐞 𝐨𝐟 𝐫𝐞𝐯𝐞𝐧𝐮𝐞, 𝐥𝐞𝐚𝐯𝐢𝐧𝐠 𝐩𝐚𝐭𝐢𝐞𝐧𝐭𝐬 𝐟𝐢𝐧𝐚𝐧𝐜𝐢𝐚𝐥𝐥𝐲 𝐩𝐨𝐰𝐞𝐫𝐥𝐞𝐬𝐬. 𝐓𝐡𝐞 𝐡𝐮𝐦𝐚𝐧 𝐜𝐨𝐬𝐭 𝐢𝐬 𝐩𝐫𝐨𝐟𝐨𝐮𝐧𝐝: 𝐃𝐫𝐚𝐢𝐧𝐞𝐝 𝐬𝐚𝐯𝐢𝐧𝐠𝐬 𝐚𝐧𝐝 […]

A new era in Alzheimer’s diagnosis began this year. The FDA granted clearance to two blood biomarker tests for Alzheimer’s disease, moving them from the category of Laboratory Developed Tests (LDTs) to In Vitro Diagnostic (IVD) devices. This transition isn’t just regulatory paperwork; it’s a critical evolution in making advanced diagnostics more accessible and standardized […]