Lung Cancer Detection Application for bioAffinity Technologies
Summary
ScienceSoft partnered with a US-based biotechnology company and in two months delivered a desktop app for lung cancer detection. The app ensures 100% stable generation of comprehensive diagnostic reports based on analysis of flow cytometry data.
About bioAffinity Technologies
bioAffinity Technologies is a Texas-based biotechnology company that develops diagnostic tests to identify early-stage lung cancer and other lung diseases, such as COPD and asthma, using flow cytometry technology.
bioAffinity Technologies wanted to accelerate the software product market entry and needed an ISO 13485-certified development partner for its lung cancer detection medical device software. bioAffinity Technologies had developed a proprietary R-based ML algorithm that was used in the test validation trial of CyPath® Lung, a noninvasive test for early detection of lung cancer. The company needed assistance to transform the algorithm into a full-fledged desktop analytics application.
Design of a Lung Cancer Detection Solution
bioAffinity Technologies entrusted ScienceSoft with the project because of our ISO-certified quality management system and expertise in FDA 501(k) and CE marking submission. Within a week, ScienceSoft assembled a team of a full-stack developer/solution architect and a project manager. Since the Customer had a crystal-clear vision of the desired project scope and had rigid software requirements, ScienceSoft’s PM suggested following the waterfall development methodology.
The discovery stage comprised two steps:
- Requirements engineering. The solution architect studied the Customer’s requirements, desired functionality, and the existing flow cytometry R script and discussed the specifics of the algorithm with the Customer’s technical and scientific team.
- Software architecture and tech stack planning. With sufficient project information at hand, the solution architect got down to planning the architecture and technical stack of the desktop app. He opted to write the core business logic of the desktop app in C++, as this programming language is optimal for intense data processing and complex calculations. The app was to use R language to communicate with the analytics script and HL7 to process patient information from a laboratory information system (LIS) in a secure way.
Development of the Lung Cancer Detection Software within Two Months
In just two months after the healthcare software concept was approved, ScienceSoft delivered the desktop application. The diagnostic system leveraging the new app functions as follows:
- The lung cancer detection app runs on a laboratory computer connected to the flow cytometer. The latter analyzes cellular events in a patient’s sputum sample and sends a set of output files to a secure network drive available from a laboratory computer.
- The desktop app inserts the path to the output files into the cancer detection R script.
- The desktop app receives an HL7 message with necessary patient data (e.g., age) from a laboratory information system database. This data is used to inform the diagnostic results, so it is essential to consider it during the analytics.
- The HL7 message with patient data is transformed into R script input arguments.
- The desktop app runs the data analysis script and interprets the results of the lung cancer diagnostic.
- Then, the generated results are sent as an HL7 message to the LIS.
ScienceSoft’s regulatory compliance consultant created technical documentation for the lung cancer detection software following the requirements for IVDR (In Vitro Diagnostics Regulation) submission.
After user acceptance testing, the Customer was satisfied with the desktop app, and ScienceSoft proceeded with its deployment.
Maria Zannes, President and CEO at bioAffinity Technologies, says:
We have been very pleased with ScienceSoft. Our project required a large amount of industry-specific methodology and algorithms to be implemented into our new software connected to EHR/LIS systems, which the team handled well. In addition to the solid technical expertise shown by ScienceSoft, its developers demonstrated a profound understanding of laboratory software specifics and integrations.
I am particularly impressed by the cooperative nature of ScienceSoft’s team. Our project required coordination with multiple companies and individuals. ScienceSoft worked well with everyone. ScienceSoft has been a competent partner for medical software development. We would recommend them as a trustworthy vendor.
They are reliable, thorough, smart, available, extremely good communicators and very friendly. We would recommend hiring ScienceSoft to anyone looking for a highly productive and solution-driven team. We look forward to working with them over the long term.
Key Value for bioAffinity Technologies
- Desktop software developed in just two months.
- Technical documentation ready for IVDR submission.
- 100% stable generation of comprehensive diagnostic reports.
- The Customer’s diagnostic solution showed 92% sensitivity and 87% specificity in detecting lung cancer in patients at high risk who had small pulmonary nodules less than 20 millimeters and 82% sensitivity and 88% specificity for all nodule sizes.
Technologies and Regulatory Requirements
C++, R, HL7, Docker, IVDR.
