BioIVT Unveils Technique to Unlock the Research Potential of Needle Biopsies
WESTBURY, N.Y. – BioIVT, a global research partner and biospecimen solutions provider for drug and diagnostic development, presented new data at the Precision Med TRI-CON conference. The data supports an innovative protocol for replicating fine needle aspirations (FNAs) in a laboratory setting using fresh frozen tissue samples. Preliminary results demonstrate the method’s promise for accurate molecular annotation and highlight its potential to revolutionize approaches to companion diagnostics development.
The industry continues to widely recognize FNA samples for their benefits, which include minimal invasiveness, rapid collection, and low risk to patients, with minimal recovery time required. Despite these advantages, barriers remain, particularly in the developmental use of diagnostic FNA samples, which typically precedes mutation status determination and limit their utility in downstream molecular testing. Additionally, FNA samples are often exhausted during diagnosis, preventing their application in research and development processes.
With over 35 years of experience in biospecimen procurement to bring the best products to researchers in need, BioIVT set out to address this limitation. Specifically, the BioIVT Molecular Sciences Team developed an innovative protocol for replicating FNAs in a laboratory setting using fresh frozen tissue samples. These laboratory-replicated FNAs create formalin-fixed, paraffin-embedded (FFPE) blocks, providing sufficient DNA and RNA for molecular testing, including immunohistochemistry (IHC) and next generation sequencing (NGS).
The novel protocol was evaluated using 19 cases with available molecular annotations obtained through PCR or NGS. Laboratory-replicated FNAs were created, and corresponding FFPE blocks were analyzed. Specifically, the data revealed:
- High Concordance with Original Samples: 89.5% of gene calls were congruent between the two block types and all 19 cases showed consistent EGFR mutation calls.
- Enabling RNA-Based Applications: A single ALK fusion call supported fusion detection in one case, highlighting the method’s potential for RNA-based applications despite degradation.
The method supports the validation of companion diagnostic assays, a crucial step for drug development and personalized treatment plans. Additionally, by sourcing from BioIVT’s biobank, the replicated FNA process eliminates the expenses associated with custom tissue procurement, ensuring innovation is not just reliable, but also highly cost-effective for both research and diagnostic needs.
“BioIVT is proud to enable smarter science and accelerate medical breakthroughs with our biobank, as shown by the results of this innovative approach,” said Shannon Richey, Vice President, Disease State Operations at BioIVT. “The long-term reliability of the data reinforces the method’s value as a robust and enduring tool for comprehensive molecular diagnostics, highlighting the potential to revolutionize approaches to companion diagnostics. The company’s continued innovation helps ensure ample material for critical testing, delivering significant cost savings and unparalleled data reliability.”
About BioIVT
BioIVT enables smarter science and accelerates medical breakthroughs by delivering high-quality personalized biospecimen solutions and research services to the life science and diagnostic industries. We specialize in control and disease state samples including human and animal tissues or preparations, ADME products and research services, cell and gene therapy products, blood, and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research and the effort to improve patient outcomes by coupling comprehensive clinical data with donor samples. By combining our technical expertise, exceptional customer service, and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in ELEVATING SCIENCE®. For more information, please visit www.bioivt.com.
