Quality you can Trust
When your clinical flow cytometry data file represents a patient, it is critical that you can rely on the results generated by your instrument and software. As the first third party flow cytometry data analysis software listed with the FDA, FCS Express is the tool of choice for the clinical reference or hospital based laboratory.
The FDA Quality Systems Regulations described in 21 CFR § 820 provide a comprehensive set of guidelines describing all aspects of the development of medical devices. These guidelines are extremely rigorous, and are designed to help promote the development of high quality medical devices for use in patient treatment and diagnosis. All procedures involving the production of FCS Express Clinical Edition (CE) have been audited by an independent validation expert and conform to the pertinent 21 CFR § 820 requirements. FCS Express CE is listed with the FDA as a medical device and is subject to all federal regulations that pertain to our class of devices.
Join the Industry Leaders
Clinical lab testing requires structure and consistency which means the tools that you use in your lab must be tried-and-true. You already know that the best way to determine a proven method is to seek out the reviews of your peers.
De Novo Software is the industry leader in providing clinical flow cytometry data analysis solutions in the clinical setting. Hundreds of clinical labs use FCS Express to analyze thousands of cases every day, year by year.
Easy Integration options
FCS Express integrates directly with Microsoft Office products and may be configured to integrate with Laboratory Information Systems. Eliminate potential manual data entry errors and head towards a paperless environment.
With FCS Express, you can export your flow cytometry results directly to PowerPoint, Excel, or PDF, publish your analysis online and collaborate with multiple testing locations.
Automate Your Quality Control
Ensuring the quality of your flow cytometry results is an important aspect of any clinical analysis, but implementing Quality Control can often be tedious and time consuming. The QC process can be largely automated in FCS Express by adding using QC checks to flag any questionable conditions so you can stop wasting time double checking on the accuracy of your results and let FCS Express handle this task for you.
Improve quality and eliminate careless errors by incorporating Custom Tokens to automatically display text or perform complex calculations during the analysis. Patient information or keywords can be automatically extracted from your cytometry data files so there is no need to worry about clerical errors or typos. Set up automatic checks to ensure all patient data files match when analyzing multiple files in complex panels. Streamline your analysis with pre-defined Alerts built right in your layouts to flag techs of suspicious results or to reflex additional testing as pre-defined conditions indicate. FCS Express allows you to increase throughput and avoid costly mistakes without sacrificing quality.
Adapts to your workflow
FCS Express provides the flexibility to fit into your routine flow cytometry workflow and processes. Standardize your reporting by designing customized analysis templates for each type of assay your lab performs. Yet still handle add on tubes or reflex testing with hidden pages that only appear when you need them. Configure your templates to automatically export the type of results each client wants based upon the rules or conditions that you define. FCS Express doesn't limit you from working the way you want.
Personalize Your Reports
Finally design a high quality, publication ready report that you can be proud of. Add your company logo and any relevant information and statistics that update in real-time as you make changes to your analysis.
Don’t be stuck recreating the same comments on every flow cytometry report. In FCS Express, you can create a library of predefined comments to drag and drop into your analysis as needed. High quality reports are exported in your format of choice so you get results how you need them, where you need, and in record time.
Minimize Validation Requirements
Just like you have to perform some assay validation even when using an FDA approved flow cytometer, you will still have to validate your own particular analysis with FCS Express CE. However, you do not have to validate every possible feature that could be used, as you would with a data analysis product that is not listed for in-vitro diagnostic use, according to FDA guidelines. You can also trust that every release of FCS Express will conform to the same high quality demanded of a medical device.
We offer a full IQ/OQ validation package for those labs who require maximum documentation.
Customer Testimonials
