Quality you can Trust

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When your sample 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

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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 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

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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 results directly to PowerPoint, Excel, or PDF, publish your analysis online and collaborate with multiple testing locations.  

Automate Your Quality Control

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Ensuring the quality of your 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

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FCS Express provides the flexibility to fit into your routine 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

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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 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

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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.

Testimonials

"FCS Express has revolutionized the way we think about data analysis. Not only are ALL the analysis tools available at your fingertips, the ability to work in a “Microsoft-like” environment makes the whole process intuitive and a great time savings. Our users have shared the same level of enthusiasm about our decision to switch to FCS Express for all our data analysis needs.”

Joanne Lannigan Ph.D.
Director, Flow Cytometry Core
University of Virginia 
School of Medicine

"FCS Express is the most intuitive, flexible, and comprehensive flow cytometry software we have ever used. The company is extremely responsive and supportive with helping us to accomplish very complex analyses and make sure the software is meeting our clinical laboratory needs. We have gone through several instrument and LIS transitions over the past 10 years and have been able to rely on the software to help alleviate the pain of those changes. We would highly recommend this for any flow lab!"

Carrie Gifford
Business Manager, Cancer & Blood Diseases Institute
Clinical Laboratories

"We have been offering FCS Express to our shared resource lab users since 2017. Thanks to the excellent support provided by De Novo Software, we have had a steady increase in users adopting this platform. De Novo Software is ready with classes, phone and online support and fits in well with the research services environment. Our users particularly like the user friendly interface!"

Jonni S. Moore Ph.D.
Professor and Faculty Director
Abramson Cancer Center Flow Cytometry and Cell Sorting Shared Resource
Perelman School of Medicine at University of Pennsylvania

 

“FCS Express from De Novo Software is an excellent software suite to facilitate researchers in their varying experimental complexities for flow and image cytometry.  The functionality and stability of the software combined with excellent and timely support has made it an important tool for research cytometry at TSRI"

Alan Saluk
Sr Scientific Director, Flow Cytometry
The Scripps Research Institute

 

"The customer service, and the functionality of the software is by far the best I’ve seen. Unless forced to, I will never touch FlowJo again"

-Anonymous

"You guys have the best customer service of ANY product I own."

David Grier

Wake Forest School of Medicine

"My users love the interface of FCS Express and find it quick and easy to learn. We love the speed and flexibility with data analysis. As a core manager, I appreciate the support the FCS Express team provides; they are always available to help my users." 

Vanessa Scarfone
Flow Cytometry Core Manager
Stem Cell Research Center
University of California Irvine

"Our group uses a wide variety of software for data analysis and processing. We are committed to using FCS express for our flow cytometry data needs as it is the most intuitive and flexible software available. The ease in interfacing with other Windows-based software and a convenient multiuser network installations were major determinants in our decision to purchase FCS Express. My staff enjoys being able to log in and process data from any desktop computing system in our facility. Application support and accessibility to a network of FCS Express users has also been very useful in developing batch processing and production protocols. Overall, I have not experienced the ease of use and broad applicability with other flow software product."

David DiGiusto, PhD

"I have found the online support material has been really helpful to my students to extend their knowledge independently."

Terry Pinfold

Cytometry and Histology Lab Manager, University of Tasmania

"I can't say enough good things about the program and the people who work on it."

Lisa Kohli
Laboratory Technician

"My function here at Integrated Oncology is to set up a work flow process for over 350 cases a day companywide so without a doubt I am choosing FCS Express to accomplish this. In my opinion there just isn't another software option for us. I need a user friendly package that will accommodate our current complex multicolor analysis as well as be able to expand for future growth, provide high quality reports for our clients, offer a virtual component for those customers that want to offer tech only flow or more closely interact with their patient results and the big challenge is that this has to happen in an extremely high volume reference laboratory. De Novo Software has been able to provide us with the features that we need and their technical support is extraordinary. I can't imagine a successful clinical lab without FCS Express; it is the "go-to" Clinical package."

Horacio Vall CLS, SCYM(ASCP)
Vice-President Science & Technology
Doctor of Biochemistry
Flow Cytometry Discipline Director Laboratory Corporation of America Holdings

"A major decision in our choice of software packages was dictated by how well we thought it would integrate with our report writing software (MS Word.) It is my impression that FCS Express does a better job with interfacing with other widely used software programs than the two other programs that we evaluated. It is hard to put into words, but FCS Express also seemed to have the look and feel of what I thought a "clinical" software program should be. Currently we spend excessive time in clerical tasks of transferring numerical values into our reports. In comparison with the other programs we reviewed, FCS Express seems to better suited to handle these repetitious tasks that are a big part of our clinical work and help separate this application from the needs of a "research" user. In short, the "automation" features of FCS Express seem stronger which are important to our clinical laboratory. Currently there is a labor tight market for qualified personnel in our area and we find it hard to attract technicians. Moreover it often takes years to fully train a technician. By using FCS Express anticipate shortening the training cycle by allowing our technicians more time to focus on the more demanding tasks in flow cytometry and less on clerical busy work. We are currently using DiVa, which is a great data acquisition program, but it does have serious limitations when used for routine data analysis and report generation thus leading to our decision to purchase FCS Express."

Nick Gonchoroff
Retired Associate Professor
Suny-Upstate Medical University

"The Hematopathology laboratory of the Shands Hospital at the University of Florida analyzes numerous bone marrow, blood and lymphoid tissue samples for the diagnosis of leukemia, lymphoma and related neoplastic conditions every day. We have been using BD's software for our data acquisition and analysis for many years. While adequate for acquisition, this software has several limitations regarding data analysis that recently prompted us to look for alternative programs for our clinical analytical work.   De Novo Software has provided an analysis tool that is completely optimized for clinical laboratories like ours. Within a short period of time, we created a drastically improved analysis protocol in FCS Express and it seems that every day we discover new features, such as tokens, alerts, panels, etc. that easily allow us to improve the quality of the analysis. Above all, I am extremely impressed with the excellence of the support staff that is always available to answer questions and courteously and positively responds to suggestions. In my opinion, FCS Express is one of the best programs available today for clinical flow cytometry laboratories."

Raul Braylan
Former Medical Director, Flow Cytometry Laboratory of the Shands Teaching Hospital at the University of Florida