March 23, 2021

Jessica Barber, MPH*,1, Yuning Wang, PhD#,1
*Author
#Reviewer
1Rapid Novor, Inc.

Abstract

In vitro diagnostics (IVDs) are one of the most commonly used tools to diagnose conditions and guide treatment decisions, and are often considered the “silent champion” of healthcare. They work by detecting the absence or presence of particular markers or by measuring the concentration of analytes or specific substances. Some examples include measuring genetic mutations or immune responses to an infection. Immunodiagnostics are  one of the most common types of IVD; they exploit antibody-antigen reactions to diagnose a variety of diseases, including infections, cardiac diseases, neurodegenerative disorders and cancers. Antibodies directly affect the reliability and repeatability of immunodiagnostics. Therefore, it is critical to rigorously assess and validate antibodies used for IVD purposes prior to clinical use as clinicians often rely on them to make treatment decisions. Across disciplines, antibody validation relies on molecular biology techniques that exclude verification of the sequence of the final protein sequence. This review highlights the challenges associated with diagnostic test development, and identifies potential solutions, including the use of protein sequencing.

Key Takeaways

  • For patent eligibility or infringement issues, access to the antibody sequence is becoming a critical piece of information
  • Batch-to-batch variability of IVD antibodies resulted in $500,000 wasted for two researchers
  • Verification of the protein sequence of antibodies can be a vital step in ensuring antibody validation
  • Protein sequencing can also be used to enhance discovery and development of IVD antibodies

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Content

  1. The State of In Vitro Diagnostics
  2. What is Damaging and Invalidating Clinical IVD Trials?
  3. How Protein Sequencing Safeguards Assays & Avoids Redevelopment
  4. Optimizing Target Discovery & Development of IVD
  5. How to Secure Indefinite Reproducibility of IVDs
  6. The REmAb® Advantage
  7. REmAb® Strengthens IVD development
  8. Conclusions
  9. References

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We Have Sequenced 3000+ Antibodies and We Are Eager to Help You.

Through next generation protein sequencing, Rapid Novor enables reliable discovery and development of novel reagents, diagnostics, and therapeutics. Thanks to our Next Generation Protein Sequencing and antibody discovery services, researchers have furthered thousands of projects, patented antibody therapeutics, and developed the first recombinant polyclonal antibody diagnostics.

Talk to Our Scientists.

We Have Sequenced 3000+ Antibodies and We Are Eager to Help You.

Through next generation protein sequencing, Rapid Novor enables timely and reliable discovery and development of novel reagents, diagnostics, and therapeutics. Thanks to our Next Generation Protein Sequencing and antibody discovery services, researchers have furthered thousands of projects, patented antibody therapeutics, and ran the first recombinant polyclonal antibody diagnostics

Talk to our scientists. We have sequenced over 3000 antibodies and we are eager to help you.