FDA Clears First Comprehensive At-Home Diagnostic Panel for Four Common Chronic Disease Markers
BOSTON, Mass. (November 23, 2025) — The U.S. Food and Drug Administration has granted 510(k) clearance to NexaHealth Diagnostics for its VitalScreen Complete Panel, the first at-home diagnostic kit capable of quantitatively measuring four critical chronic disease biomarkers from a single fingerstick sample. The regulatory milestone positions the company to launch what analysts describe as the most comprehensive chronic health monitoring solution available directly to consumers.
The VitalScreen panel delivers laboratory-comparable results for hemoglobin A1c (HbA1c), lipid profile (total cholesterol, HDL, LDL, triglycerides), high-sensitivity C-reactive protein (hsCRP), and thyroid-stimulating hormone (TSH) within 15 minutes of sample collection. While individual at-home tests for some of these markers have existed, this represents the first FDA-authorized integrated platform combining all four, addressing a market that Grand View Research values at $11.39 billion in 2024 with projected growth to $18.32 billion by 2030 at an 8.4% compound annual rate. The integration of multiple validated assays onto a single cartridge reflects two years of clinical validation involving 3,400 patients across 28 healthcare sites.
Healthcare providers have increasingly embraced remote monitoring since the COVID-19 pandemic normalized home-based healthcare delivery. The Administration for Strategic Preparedness and Response and NIH’s Home Test to Treat program, launched in January 2024, demonstrated that consumers could reliably perform complex testing protocols when provided proper digital guidance. NexaHealth’s proprietary smartphone app provides real-time AI-driven interpretation, automated physician reporting, and longitudinal trend analysis—addressing the primary barrier to chronic disease management: inconsistent monitoring.
“The clearance of our VitalScreen platform marks a pivotal shift from reactive sick care to proactive health management,” said Dr. Elena Marchetti, CEO and co-founder of NexaHealth Diagnostics. “For the 60% of American adults living with at least one chronic condition, this technology eliminates the friction of quarterly lab visits while providing physicians with continuous, actionable data to optimize treatment decisions. We’re not just delivering test results; we’re enabling a new care paradigm where patients become true partners in their health journey.”
Market adoption data supports this transition. According to a CDC analysis, at-home test utilization among U.S. adults increased 340% between 2021 and 2022, with sustained engagement demonstrating consumer readiness for sophisticated self-testing. The chronic disease segment specifically is projected to capture 42% of the at-home testing market by 2030, driven by aging demographics and the expansion of value-based care models that reward prevention. Rheumatologists and endocrinologists participating in VitalScreen’s clinical trials reported 78% fewer appointment no-shows when patients used home monitoring tools.
NexaHealth will initially distribute the $89 VitalScreen kit through partnerships with major retail pharmacy chains and its direct-to-consumer platform starting December 15, 2025. The company has established CLIA-waived processing agreements with Quest Diagnostics for physician-ordered monitoring programs and secured CPT codes for reimbursement under Medicare Part B and most commercial payers. First-year production capacity of 2.5 million units is allocated equally between direct-to-consumer and healthcare provider channels.
The technology holds particular promise for rural and underserved populations, where 23% of patients with chronic conditions miss recommended screenings due to geographic barriers, according to HHS data. By enabling clinical-grade monitoring at home, VitalScreen could reduce preventable emergency department visits—a cost driver that CMS estimates at $8.3 billion annually for uncontrolled diabetes and cardiovascular complications alone.
About NexaHealth Diagnostics
Founded in 2021 by former Mass General Brigham clinicians, NexaHealth Diagnostics develops integrated at-home testing technologies for chronic disease monitoring and infectious disease detection. The company operates a 45,000-square-foot ISO 13485-certified manufacturing facility in Waltham, Massachusetts, and has raised $47 million in Series B funding led by Andreessen Horowitz Bio. Its advisory board includes former FDA Center for Devices and Radiological Health director Dr. Jeffrey Shuren and former CMS Administrator Dr. Don Berwick.
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