Pathologists
The Crow’s Nest™ Biopsy Catchment System is an Enabling Tool for the Pathologist.
If interventional radiologists in your institution use the Crow’s Nest after performing core needle biopsies of solid lesions, you will receive at least two specimens from each procedure:
- One, the solid tissue, will arrive in a formalin cup, ready for paraffin embedding and sectioning (FFPE) as usual.
- The other specimen, the dislodged tumor cells (DTCs), will arrive in 4 mL of DNA/RNA preservation solution, making them an ideal material for molecular testing.
Corramedical believes that as genomic sequencing technology continues to advance, the rising need for the already limited core needle biopsy (CNB) tissue specimen will accelerate.
These new diagnostic needs may come from direct tissue usage for evaluation of spatial multi-omics, or cross-over companion diagnostics for emerging therapeutics (e.g., protein expression for the evolving field of antibody-drug conjugates).
These new diagnostic needs may come from direct tissue usage for evaluation of spatial multi-omics, or cross-over companion diagnostics for emerging therapeutics (e.g., protein expression for the evolving field of antibody-drug conjugates).
More demand on pathologists
These technologies will increase demand on the hospital’s usage and the pathologist’s management of the core needle biopsy specimen. This makes prudent and maximum utilization imperative.
Other tissue usage limitations are compliance issues pathologist face by state, federal and professional regulatory agencies that mandate the tissue, as part of a patient’s medical record, not be depleted or exhausted.
Other tissue usage limitations are compliance issues pathologist face by state, federal and professional regulatory agencies that mandate the tissue, as part of a patient’s medical record, not be depleted or exhausted.
A solution based on good stewardship of cellular resources
A solution to this problem is in the recovery of dislodged tumor cells (DTCs) that are created, and normally discarded with the needle, from the microtrauma associated with the biopsy procedure
The objectives of this application are to demonstrate these DTCs can be recovered using a novel medical device (the Crow’s Nest) designed specifically for this purpose, and that there are sufficient amounts of recoverable nucleic acids in these DTCs of high molecular quality that are thoroughly representative of the parent tissue’s molecular profile.
The objectives of this application are to demonstrate these DTCs can be recovered using a novel medical device (the Crow’s Nest) designed specifically for this purpose, and that there are sufficient amounts of recoverable nucleic acids in these DTCs of high molecular quality that are thoroughly representative of the parent tissue’s molecular profile.
A fully representative surrogate source of the parent core needle biopsy tissue
A lot of clinical benefits from a simple change in biopsy handling
- Improved Patient Care: The presence of the extra specimen means patients are less likely to be subjected to a re-biopsy, which can involve anxiety, time, transportation, days off work, pain, and complications.
- Elimination of Pre-Analytical Variability and Harmonization of Nucleic Acid Quality Among Different Institutions: Current biopsy procurement protocols differ widely among hospitals. The time from procurement to processing can vary from a few hours to a day or more, leading to degradation of nucleic acids and artifactual changes in the tissue’s molecular profile. The Crow’s Nest protocol can reduce pre-analytic variability to < 30 seconds.
- Material available for clinical trials: Depending on the number of passes (or attempts to acquire tissue in 1 setting), all the dislodged diagnostic tumor cells (DDTCs) from each core needle biopsy needle pass can be stored and made available for biomarker testing should the patient decide to enter a clinical trial, eliminating a major issue for some clinical trials.
- Equitable Use: The simplicity of using the Crow’s Nest (figure 4) allows it to be used at any institution, making it attractive to those with fewer resources. The use of a nucleic acid stabilizing reagent in the lower chamber (figure 4B) allows for storage of DNA at room temperature or 4C. Some institutions may not have a -80C deep freezer. This also allows for lower shipment costs to reference laboratories for molecular testing, eliminating the need for dry ice.
Pathologist reviews are enthusiastic
- “A breakthrough” – Natalia Rush, McLaren Hospital, Petoskey, Michigan
- “I consider this a better way to do it.” – Noel Ceniza, McLaren Hospital, Petoskey, Michigan
- “Why would you want to run your molecular testing or NGS on fragmented damaged nucleic acids? Instead, use fresh cells untouched by formalin.” – Fred Mojica, Chief of Pathology at Niagara Falls Memorial Medical Center and co-founder of Corramedical, Inc.
What to say to your Interventional Radiology colleagues: You will be Saving Cells That Would Otherwise be Lost:
- The Crow’s Nest is a novel multi-container device that allows you to capture, save and preserve a valuable biologic resource that is normally lost to medical waste – the DTC from the micro-trauma of the CNB procedure.
- It takes nothing additional from the patient, and it takes the interventional radiologist approximately one minute to use.
If you would like help persuading the interventional radiologist(s) in your institution to use the Crow’s Nest, contact us and we would be happy to help initiate that discussion .
- You may immediately route this liquid specimen to your hospital’s clinical molecular testing lab.
- You may keep it with the patient’s tissue in the pathology department for use whenever the patient’s oncologist orders a test.
- If your oncologist sends you a request for molecular testing, you send this instead of taking a piece of the precious resource that is the paraffin tissue block for the patient.
“It is not uncommon for a pathologist to examine a block of tissue and realize that submitting the material desired by one clinical trial will completely exhaust the remaining biopsy sample. If pathologists fulfill this request, they will violate federal regulations, state law, and accrediting agency requirements. If they refuse to fulfill the request, the patient will not qualify for the study, which will upset the patient and oncologist and will deny the patient a therapy with the potential to extend their survival and/or improve their quality of life. When confronted with a request for limited biopsy tissue as a condition of trial enrollment, pathologists, local institutional review boards, and hospital legal counsel in the United States struggle with a catch-22 situation.”
Avoid this “catch-22 situation” described by Drs. McCall and Dry. Encourage the interventional radiologists at your institution to use a Crow’s Nest after every core needle biopsy, and receive a source of fresh cells available for molecular testing that may allow some patients to qualify for clinical trials without placing any material requests on their solid tissue block sample.
Avoid this “catch-22 situation” described by Drs. McCall and Dry. Encourage the interventional radiologists at your institution to use a Crow’s Nest after every core needle biopsy, and receive a source of fresh cells available for molecular testing that may allow some patients to qualify for clinical trials without placing any material requests on their solid tissue block sample.
DTCs for testing allow pathologists to solve the tissue exhaustion problem as it relates to laboratory accreditation: Quoting from McCall SJ, Dry SM. Precision Pathology as Part of Precision Medicine: Are We Optimizing Patients' Interests in Prioritizing Use of Limited Tissue Samples? JCO Precis Oncol. 2019 Dec; 3:1-6.
The clinical goal is to demonstrate that these DTCs can serve as a fully representative surrogate source for molecular testing of the parent CNB tissue, thereby reducing or eliminating tissue exhaustion, negating the need for a re-biopsy, preserving the tissue for a future increased demand in testing, and creating a source other than these CNB specimens of high-quality substrate (DTCs) for molecular profiling.
