What is it?
The Crow's Nest™ Biopsy Catchment System is a mechanical device that resolves a growing clinical problem that affects all patients with a potential cancer diagnosis. Anyone who undergoes a core needle biopsy procedure faces the potential that their biopsy specimen may not have sufficient tissue for all the tests his/her doctor wants to be run on it. This phenomenon has become so common that it has been given a descriptor in pathology and oncology journals: Tissue Exhaustion.
When a biopsy paraffin block runs out of tissue, patients miss out on molecular testing tests – which means that many miss out on newer, safer cancer-fighting drugs (often called “Precision Medicine” drugs) and are instead left with the brutal traditional options of radiation and chemotherapy. Ordering a second biopsy carries several disadvantages, because patients hate it, and insurance may only cover a single biopsy. But a solution to this problem has been hiding in plain sight. In every biopsy procedure room there is a medical waste container. This is where the biopsy needle goes after the biopsy procedure is over. The tissue is deposited in a specimen container, and the needle is thrown away.
But on the needle are, of course, thousands of dislodged cells. These are living, viable cells, fresh out of the patient’s body, from the area that was just biopsied. They are a valuable, potentially highly useful, and currently untapped biological resource that is simply being thrown away. If these loose cells could be recovered from the needle before it is discarded, each biopsy procedure would result in two specimens instead of one.
The Crow’s Nest™ Biopsy Catchment System does that. It’s a simple-to-use device that, when used by interventional radiologists at a hospital at which core needle biopsies are performed, allows every patient to benefit from the creation of two specimens rather than one, yielding valuable molecular testing and potentially life-saving genomic information.
Provide your clinical lab with high-quality starting material for molecular testing.
Make use of a biologic resource that takes nothing additional from the patient – because it was going to be discarded anyway
Use fresh cells from the target tissue site – undamaged by formalin – for genomic sequencing
Use the Crow’s Nest after all of your core needle biopsies, and spare some of your patients from a second biopsy
Use the Crow’s Nest after all of your core needle biopsies, and make genomic sequencing standard for all biopsy patients. Then give some cancer patients the good news that they qualify for a precision medicine trial that may help them avoid chemotherapy.
Save money: the Crow’s Nest more than pays for itself by saving hospitals from the substantial cost of second biopsies. Some second biopsies are unavoidable, when the first biopsy missed the target tumor tissue. But most second biopsies ordered today are for the reason that the tissue harvested is insufficient for all the testing that oncologist would like to run. Those biopsy procedures may be avoided by routine use of the Crow’s Nest.
Source: Shahla Masood MD, et. al. Comparative cost-effectiveness of fine needle aspiration biopsy versus image-guided biopsy, and open surgical biopsy in the evaluation of breast cancer in the era of affordable care act: A changing landscape Diagnostic Cytopathology 2015;43:605–612].
Enable RNA translocation testing: Screening for RNA translocations is not often performed today because RNA is more delicate and difficult to assay than DNA, so it normally requires fresh cells not treated by formalin (such as from a fine needle aspirate)
Enable additional cancer testing, such as organoid creation – organoid creation can be extremely helpful to characterize and treat some patients’ cancers, and it requires a source of non-formalin preserved cells, such as those recovered by use of the Crow’s Nest
Why would you want to run your molecular testing or NGS on fragmented, damaged nucleic acids? Instead, use fresh cells untouched by formalin.
Why use it?
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The Crow's Nest Biopsy Catchment System is a Class I exempt device, manufactured in the United States of America.
Corramedical, Inc. is enrolling alpha testing sites. If your healthcare institution doesn’t already use the Crow’s Nest, and you are interested in discussing becoming a testing center, please contact us at: info@corramedical.com, or call
1-833-4-BIOPSY.
The six groups who want the Crow’s Nest to be used after every core needle biopsy, and why:
They perform core needle biopsies. In some cases an interventional radiologist feels he/she has acquired enough tissue for diagnostic purposes, only to find from the collaborating pathologist that it is not the case. Use of the Crow’s Nest after ever core needle biopsy provides a source of fresh, undamaged cells from each patient’s tumor, available for molecular testing, resolving those situations. If you are an interventional radiologist interested in saving time and avoiding patient callbacks, by making sure the entire breadth of what you have biopsied is available for the molecular testing that may be needed.
Interventional Radiologists
Clinical Lab Directors
Oncologists
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Hospital Administrators
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Patients
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1) Dry S, Grody WW, Papagni P: Stuck between a scalpel and a rock, or molecular pathology and legal-ethical issues in use of tissues for clinical care and research: What must a pathologist know? American Journal of Clinical Pathology 137:346-355, 2012
Pathologists
They want high-quality starting material for molecular testing. Today, patient specimens of nucleic acid material submitted for genomic or molecular testing (especially for the increasingly common Next Generation Sequencing, or NGS) is sourced from parts of solid tissue specimens that have undergone formalin fixation and paraffin embedding (FFPE). That preparation results in DNA being chemically altered (cross-linked) and fragmented into smaller segments. Why would you want to run your molecular testing or NGS on fragmented damaged nucleic acids? Instead, you can now perform NGS on DNA and RNA from fresh cells untouched by formalin. If you are a clinical lab director interested in finding out if the hospital or hospital systems you serve could implement a Crow’s Nest program and thereby provide you with fresh, high-quality starting material for molecular testing, consisting of long (unfragmented) DNA chains that have not been cross-linked because they haven’t been exposed to formalin,
They manage the patient. They want the most complete set of diagnostic data they can have to make the best decisions for their patients. They typically believe that all patients with solid tumors undergoing a rule-out workup for any kind of cancer should have the benefit of molecular testing or next generation sequencing (NGS) to characterize their cancer type and be aware of any cancer cell vulnerabilities that may qualify the patient for a precision medicine drug, even if still experimental, to avoid radiation and chemotherapy. If you are an oncologist interested in bringing your institution up to this emerging new standard of care
No patient wants to undergo a second biopsy if a single biopsy would suffice. Routine use of the Crow’s Nest after every core needle biopsy may save many patients from this additional tissue trauma. It also means that every patient can benefit from the recent advances in Precision Medicine that allows some cancers to be targeted and cured with highly-specific drugs that differentiate between tumor cells and healthy cells. This means those patients can potentially avoid undergoing chemotherapy and/or radiation therapy, with all of their well-known side effects. If you are a patient with a solid tumor and you are scheduled to undergo a core needle biopsy,
They know that the average hospital spends approximately $440,000 per year on un-reimbursed second biopsy expenses. Subjecting patients to second biopsies becomes necessary when oncologists want to order molecular testing on tumor cells, and the biopsy specimen has been exhausted. Use of the Crow’s Nest after ever core needle biopsy (an average U.S. hospital performs over 700 per year) provides a source of fresh, undamaged cells from each patient’s tumor, available for molecular testing, and costs far less than the amount it saves by avoiding unreimbursed second biopsies. In addition to that cost savings, the procedure of segregating biopsied tissue into two specimens (one solid tissue for microscopic examination and one loose cells for molecular testing) sometimes warrants its own reimbursement. If you are a hospital administrator interested in trialing the Crow’s Nest at your institution,
They are responsible for tissue sample handling. Literally, pathologists are the caretakers of all tissues removed during clinical care, [1] and there are federal, state, and sometimes local laws governing how pathologists must treat those tissues. Today, they often find themselves facing impossible decisions between requests for tissue from a biopsy to qualify a patient for a potentially life-saving clinical trial, which would exhaust the tissue for which they are responsible, and complying with federal regulations, state law, and accrediting agency requirements that require them to keep a certain volume of the patient’s tissue in storage. If you are a pathologist interested in avoiding the “catch-22” situation you are placed in whenever faced with a request for tissue from a biopsy sample that would exhaust it for a clinical trial qualification screening, click here.
