Introducing Integrity’s new research suite of services to support diagnostic research and development, analytical testing for 510(k) submissions, and vetting of new diagnostic technologies.
Let Integrity Sciences be your trusted laboratory partner in support of diagnostic product development, 510(k) analytical studies, competitive head-to-head studies, and data generation for publication and fundraising. Integrity’s highly experienced laboratory and research teams will help you efficiently and cost-effectively advance your product portfolio through key commercialization steps.
Integrity’s Benefits
- CAP-accredited, CLIA high-complexity laboratory staffed with licensed medical technologists
- Experienced research team leadership with decades of IVD R&D experience
- Excellent data management, documentation and communication
- Competitive market pricing, streamlined quoting and contracting
Integrity’s Differences
- Extensive knowledge of IVD design, development, commercialization, pipeline strategy and fundraising
- Large network of IVD experts in regulatory, quality, sales, marketing and scientific affairs
- Access to key opinion leaders in infectious disease, public health, microbiology, human factors and point-of-care testing
Analytical Testing
- Execution of the analytical studies required to support product development and 510(k) submissions
- Analytical study protocol development support
- Analytical studies include LOD, inclusivity, exclusivity, reproducibility, linearity, interfering substances, stability, shipping, etc.
- Control and residual clinical sample sourcing
- Repository of residual clinical samples for contriving study specimens
- Human factors usability testing
Diagnostic Technology Vetting
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Data generation to support fundraisingactivities or investment decisions
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Proof-of-concept testing
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Product pipeline vs technology capabilities analysis
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Product/market fit assessment
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Diagnostic technology areas of expertise include point-of-care diagnostics, overthe-counter diagnostics, lab-based CLIA moderate and high-complexity diagnostics for infectious diseases, genetics, oncology, and reproductive health