A novel device to simultaneously collect standard core biopsies and dislodged cancer cells from solid tumors for molecular testing.

Abstract

e13898 Background: The molecular profiling of breast cancer is becoming an integral component of patient care. Routine pathology lab processing creates barriers to accessing high quality nucleic acids from these specimens. Cold ischemic time (CIT), the slow infiltration rate of formalin in solid tissue, duration of formalin exposure, fragmentation of DNA due to cross-linking and impaired recovery from fixed tissue each contribute to a suboptimal starting source. A novel approach to the processing of biopsy specimens is needed capable of meeting the demands for molecular testing, while preserving the integrity of the solid tissue specimen for histopathologic assessment. A largely underrecognized byproduct of the biopsy procedure, the generation of dislodged tumor cells (DTC) created from the microtrauma associated with the biopsy needle’s cutting sheath, represent an underutilized resource that if properly managed, can result in molecular profiling being available for a larger proportion of solid tumor patients. Methods: An IRB approved this study. Four breast cancer specimens were sent to the pathology laboratory as fresh specimens upon completion of surgery. Upon receipt, a gross examination was performed followed by the procurement of ex-vivo core needle biopsy specimens using an 18-gauge needle. The cutting sheath was then retracted and the sampling chamber swirled into a novel 2-chamber medical device (the Crow’s Nest Biopsy Catchment System (CN), Corramedical, Inc.) developed to recover and separate the DTCs and the tissue core generated from the biopsy procedure. The tissue core was processed through traditional formalin fixation, paraffin embedding (FFPE) for morphologic examination. The separated DTCs were stabilized in a chaotropic agent and then subjected to extraction of their nucleic acids (GenFind V3, Beckman Coulter). Results: The time frame of the specimens using the CN from being biopsied to specimen stabilization reduced cold ischemic time to less than five (5) minutes. The separation of the DTCs from the parent tissue core created a new processing pathway involving no exposure of them to FFPE. Extraction of the DNA from these DTC yielded high molecular weight than DNA extracted from comparable formalin fixed tissue. The parent tissue core after FFPE remained intact and demonstrated the same morphologic features to the corresponding tumor mass it originated from. Conclusions: Medically-relevant molecular testing samples were created from what would have been medical waste. The use of the CN device represents a novel means to obtain high quality nucleic acids for molecular analysis from DTC that become separated from the parent tissue during the biopsy procedure. The Crow’s Nest is a novel way of creating 2 specimens from what was originally intended to be one, without taking anything from the tissue core, maximizing the value of what is often a limited resource.