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BioPharma

Why Choose Precipio?

 

We use proprietary and groundbreaking Ice Cold PCR (ICE COLD-PCR) technology to enrich samples upstream for better accuracy and sensitivity for mutation detection. This technology coupled with our scientific, clinical and project management expertise makes us the ideal choice for your next Biomarker Identification Program.

 

Contact us about your program goals

The Science to Create Non-Invasive “Liquid Biopsies”

 

The ability to detect mutations from cell free DNA (cfDNA) in “liquid biopsies” enables more efficient and more effective clinical diagnosis and patient monitoring. Sampling is non-invasive, requiring only a blood draw, allowing simpler and more frequent sample collection. Precipio will help you design a “liquid biopsy” to detect the mutations in DNA isolated

from bodily fluids that are most appropriate for your product using our personalized biomarker development program.

Who Can Benefit from Our Services and Technology?

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Biotech Image
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Pharma

 

Precipio will help you detect known and unknown genetic mutations in DNA isolated from blood, serum and other bodily fluids to advance your biomarker development program

Biotech

 

If you need to enrich any type of sample for mutant DNA, then take advantage of our proprietary ICE COLD-PCR technology

Clinical Diagnostics

 

Detecting small amounts of mutant DNA in a liquid or tissue sample can be impossible unless you let our ICE COLD-PCR technology enable you to detect known and unknown mutations with unheard of sensitivity

Oncologists

 

Precipio has made the possibility of true “Liquid Biopsies” a reality for the oncology community with our groundbreaking ICE COLD-PCR

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State-of-the-art Compliance & Internal Processes

Project Management Expertise

 

Our extensive project management expertise and systems ensures the best path is taken for development of CE-IVD, PMA and 510k diagnostic products. Our proactive nature ensures timely completion of assay validation studies in accordance with appropriate regulatory standards.

Extensive Design Controls and Standards

 

We implement design controls and standards which means all assay and platform development is performed under QSR, 21CFR part 11, ISO regulatory standards, CDRH and/or other guidelines, as appropriate for your project. A validated test enables fast entry into clinical trials by ensuring concurrent submission of companion diagnostic test or kit and a drug for regulatory approval.

Fully Integrated Quality Systems

 

We have established integrated quality systems in a CLIA facility in support of trial-associated services and future, approved LDT-PMA testing service offerings.

Clinical, Pharmaceutical and Technical Expertise

Our clinical, pharmaceutical and technical expertise has distinguished Precipio as a customer-oriented service and development company. Traditionally, we form long-term partnerships to ensure successful entry into the LDT-PMA space.

Interested in learning more? Call us at 203-787-7888

We look forward to discussing how we can help you accelerate your biomarker discovery program

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