Diagnostics from Concept to Market.EDP Biotech is a Specialty CRO, Reference and Research Laboratory specializing in In Vitro Diagnostics (IVD). Get In TouchLearn More
We Can Help
Unpredictable costs and timelines, regulatory hurdles, and the variables of validations and clinical investigations are complicated.
The road from an envisioned or investigational diagnostic device to a marketable product is often overwhelming. With so much at stake and so much to juggle, it’s hard to know where to begin.
That’s where we come in.
EDP Biotech Solutions
Time is critical in getting a diagnostic device to market, and you need a CRO that is agile and responsive to help you meet your deadlines. Our CLIA and ISO 13485 certification allow us to be your one-stop-shop for contracting all areas of your clinical research trial.
Our CLIA certification, scientific expertise, and range of in-house molecular and proteomic comparator devices have all your esoteric reference laboratory needs covered. Reportable patient samples, specialized lab developed tests (LDT) to assist and aid physicians in making diagnosis and making the best intervention possible.
We know the ins and outs of developing diagnostics from the earliest stages of conceptualization because that’s where we started. Our first commercial product, ColoPlex, is a new multimarker in vitro diagnostic assay to be used in the early detection of colorectal cancer. Let our experience work for you to develop your Vitro diagnostic tests whose primary target is proteins present in the early stages of biological changes.
You’ve developed your diagnostic, and you are looking for a CDMO that understands your unique needs in the IVD space. We’ve got you covered. Developing our own cancer diagnostic product, Coloplex, earned us the valuable experience to provide excellence in multiplex assay development and small-scale contract manufacturing. Let us provide expertise and consulting in getting your regulatory-approved diagnostic device produced and into the market.
Who We Are
EDP stands for Early Detection Products and we specialize in in vitro early-detection bioassay development and commercialization in oncology, infectious disease and women’s health. We offer Reference Laboratory and CRO services for diagnostic devices and companion diagnostics.
Our team is focused on delivering “VIP” patient care, quality products and contract testing services with over a century of combined experience in biomarker discovery, immunoassay development, clinical studies, and rapid response testing.
We at EDP Biotech understand how daunting the path ahead may be, and we are here to help. We are a CRO with experience navigating the hurdles, timelines, budgets and many layers of requirements needed to get a diagnostic device out of the laboratory and submitted and market approved.
We are experienced, responsive to our clients, agile to change, and dedicated to solving any problem our clients face. We are at your service.
Our mission is to “Detect Early and Save Lives” by developing and commercializing simple and cost-effective diagnostics that detect disease early.
We would love to connect if you have questions or if you’re interested in partnering with us. Please complete the information below and we will be in touch very soon!