In April 2026, bioAffinity Technologies' CyPath Lung diagnostic reached a record monthly sales level and grew nearly 300% year-over-year compared to April 2025. This is not an announcement of a completed trial or a regulatory milestone. This is preliminary unaudited data from a commercial product already in doctors' hands, already generating revenue, already changing clinical practice. The company's CEO Maria Zannes framed it carefully: growth "continues to accelerate at a rapid pace as the value of our novel lung cancer diagnostic is increasingly being recognized." Translation: physicians across multiple sites are ordering this test routinely.
The baseline context matters for reading what 300% actually means. CyPath Lung's Q1 2026 unit sales had already jumped 146% year-over-year, beating the company's internal forecasts. Full-year 2026 guidance predicts unit sales growth of greater than 100% over 2025, which means April's 300% figure is pulling the overall trajectory upward faster than the company itself expected three months ago. This is the signature of genuine adoption inflection: not steady ramp, but acceleration from adoption to network effects. Pulmonologists are talking to other pulmonologists. Workflows are being modified to accommodate the test. Ordering sites are expanding.
CyPath Lung identifies cancer-related cells in patient sputum using flow cytometry (a cell-sorting technique that reads fluorescent markers) combined with proprietary AI. The clinical setup is surgical: 92% sensitivity, 87% specificity, 99% negative predictive value in the population that matters, high-risk patients with indeterminate lung nodules smaller than 20 millimeters. That 99% NPV is the economic wedge. A negative result tells a pulmonologist with 99% confidence that a patient does not have lung cancer, which means they can defer or avoid expensive CT follow-ups and invasive biopsies that expose the patient to radiation and infection risk. The test runs on sputum, not blood, no invasive collection. One sputum sample costs less than a high-resolution CT, less than a PET scan, orders of magnitude less than a biopsy or surgical nodule removal.
Who actually benefits is not ambiguous. Pulmonologists ordering the test benefit from a non-invasive risk filter that reduces downstream false-positive workups. Patients with benign nodules benefit from diagnostic certainty without surgery. Health systems and payers benefit from deferred or eliminated imaging cascades on tens of thousands of patients annually. The economics are compelling enough that even a 300% jump makes sense: the installed base of high-risk patients with indeterminate nodules in the US is enormous, the imaging-and-biopsy status quo is expensive and invasive, and CyPath Lung is the first non-invasive alternative with clinical validation in the specific population where it matters.
The company is already moving beyond lung cancer diagnostics. It is running a large-scale longitudinal study to generate further validation data on CyPath Lung, expanding its use in monitoring lung cancer survivors (patients at high recurrence risk), and developing diagnostics for asthma and COPD using the same flow-cytometry-plus-AI platform. If that platform translates across respiratory disease, turning sputum into a diagnostic readout for multiple conditions, the unit economics improve further: one test becomes a panel, one install base becomes a reason to order multiple times per patient population.
What to watch: whether the >100% full-year guidance holds and how the April spike propagates into Q2 and Q3 data. If CyPath Lung sustains month-over-month growth above 20% for the remainder of 2026, the company has moved from early adoption to mainstream clinical use. Watch also whether the company can maintain pricing as volume scales, commoditization is the natural enemy of any diagnostic platform. And track the asthma and COPD launches: if those clinical validations hold, bioAffinity transitions from a lung cancer play to a respiratory disease company, which opens a much larger addressable market and reshapes its competitive position against imaging-centric workflows.