Diagnostics from Concept to Market.

EDP Biotech is a Boutique CRO, Reference and Research Laboratory specializing in In Vitro Diagnostics (IVD).
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We Can Help You

The road from an envisioned or investigational diagnostic device to a marketable product is often overwhelming. With unpredictable costs and timelines, regulatory hurdles, and juggling so many variable to complete validations and clinical trials, it’s hard to know where to begin. That’s where we come in.

EDP Solutions

Reference Laboratory

Clinical Research

Multiplex CDMO

Diagnostic Developer

Reference Laboratory

Our CLIA certification, scientific expertise, and range of in-house molecular and proteomic comparator devices have all your 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. 

CRO Services

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.

Multiplex CDMO Services

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 contract small scale manufacturing. Let us  provide expertise and consulting in getting your regulatory approved diagnostic device produced and into the market.

Diagnostics Developer

We know the ins and outs of developing a diagnostic 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.

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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.

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Our Approach

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.

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Our Mission

Our mission is to “Detect Early and Save Lives” by developing and commercializing simple and cost-effective diagnostics that detect disease early in humans and animals. Our multiplexing technologies identify multiple biological targets and we can customize your assay to your research and clinical needs whether you are performing preclinical or human trials.