Case Study: bioAffinity Technologies achieves stable lung cancer diagnostics with ScienceSoft

bioAffinity Technologies launches lung cancer detection app in 2 months with ScienceSoft

bioAffinity Technologies, a US-based biotechnology company, needed to accelerate the market entry of its CyPath® Lung diagnostic test by transforming its proprietary R-based algorithm into a full-fledged, compliant desktop application. They partnered with ScienceSoft, an ISO 13485-certified vendor, for its expertise in medical software development and regulatory submission.

ScienceSoft developed a desktop application in just two months. The solution, built with C++ and R, analyzes flow cytometry data and integrates with lab systems via HL7 to generate diagnostic reports. The delivered software ensured 100% stable report generation and was accompanied by technical documentation ready for IVDR submission. The diagnostic test itself demonstrated high efficacy, with 92% sensitivity and 87% specificity in detecting lung cancer.

bioAffinity Technologies