Clinical Specimen to Support IVD R&D

The growth in research and development activities focused on personalized medicine is rising exponentially. It is crucial that companion diagnostic developments aligned with personalized medicine development utilize ethically collected, well-characterized human specimens and comprehensive tissue-based research services.

Below are just some of the diseased tissues and biofluids we will ethically source for your IVD development needs:

• Oncology tissues with board-certified pathology confirmation of diagnosis
• Pre- and post-treatment biofluids
• Infectious disease/serology cohorts with confirmed or suspected diagnosis
• Clinical remnant samples with associated clinical data and test results representing autoimmune, cardiovascular, dermatological, neurological and endocrine diseases, among others

We will also make collections using your desired vials or vacutainers, coagulant of choice, volume, processing and more.

Mutation analysis is now being used as a diagnostic tool for many diseases, including cancer. Diagnostic assays for specific biomarkers for patient stratification is in ever-expanding development. BioIVT supports these efforts through standard mutation analysis for lung, melanoma and colon cancers, as well as custom mutation screening on tissues and biofluids.

Look to BioIVT for expertise in the processes required for the ethical acquisition of biospecimens that cover a wide range of disease states, and the protocols needed for the production of reliable data.

Right Cohort, Right Data, Right Regulatory for IVD Validation

For IVD validation, you need the right cohort with the right data and the right regulatory approval. With over 200-IRB approved clinical sites, BioIVT provides clinical specimens for nearly all disease states, confirmed positive or negative. Collected to your specifications, we will provide clinical diagnosis, antibody or viral titer, test method, as well as additional laboratory data, such as age, sex and treatment information.

Access to Donor and Facilities to Bring Your Test to Market

When it comes to Point of Care Device Testing, partner with BioIVT to ensure your success. With diverse collection capabilities and on-site access to donors, we can operationalize your protocol and accelerate your POC device validation. At our donor centers, we will ensure that key components such as assay chemistry and microfluidics function as designed. In addition, we can integrate other components to guarantee a seamless POC testing environment.

Dr. Cheryl Berne, BioIVT’s Donor Center Medical Director, explains how donor centers help POC device developers bring their tests to market in this article, originally published in Clinical Researcher.

For effective diagnostic kit development and manufacturing, you need a reliable source of control and calibrator plasma. With our acquisition of KEYSTONE Biologicals in 2019, we now offer high first pass disease state plasma, collected from well-characterized repeat donors, which can help keep your development moving forward. With existing donors representing autoimmune, immunology, serology and infectious disease, and the ability to recruit even more valuable donors, we will quickly provide samples to be tested in your facility, and we will ensure that these samples meet your assay and equipment needs.

We offer reagents specifically designed for your IVD research and kit needs, such as Immunoglobulin Inhibiting Reagent (IIR), Rheumatoid Factor (RH) and synthetic urine and cerebrospinal fluid.