Needle Biopsy Adequacy in the Era of Precision Medicine and Value-Based Health Care

Abstract

Context.— Needle biopsy of diseased tissue is an essential diagnostic tool that is becoming even more important as precision medicine develops. However, the capability of this modality to efficiently provide samples adequate for diagnostic and prognostic analysis remains quite limited relative to current diagnostic needs. For physicians and patients, inadequate biopsy frequently leads to diagnostic delay, procedure duplication, or insufficient information about tumor biology leading to delay in treatment; for health systems, this results in substantial incremental costs and inefficient use of scarce specialized diagnostic resources. Objective.— To review current needle biopsy technology, devices, and practice with a perspective to identify current limitations and opportunities for improvement in the context of advancing precision medicine. Data Sources.— PubMed searches of fine-needle aspiration and core needle biopsy devices and similar technologies were made generally, by tissue site, and by adequacy as well as by health economics of these technologies. Conclusions.— Needle biopsy adequacy can be improved by recognizing the importance of this diagnostic tool by promoting common criteria for needle biopsy adequacy; by optimizing needle biopsy procedural technique, technologies, clinical practice, professional education, and quality assurance; and by bundling biopsy procedure costs with downstream diagnostic modalities to provide better accountability and incentives to improve the diagnostic process.

Utilization of cytology smears improves success rates of RNA‐based next‐generation sequencing gene fusion assays for clinically relevant predictive biomarkers

“…Because gene fusions have diagnostic, therapeutic, and prognostic significance, 37,38 substantial efforts have been made to validate high‐throughput platforms that can recognize multiple oncogenic gene fusions in clinical specimens. Patients with advanced cancers are not candidates for curative surgical excision; hence, minimally invasive procedures such as core‐needle biopsy (CNB) and/or FNA are the typical means of tumor sampling for diagnosis and molecular studies 34,39 . At our institution, molecular testing is preferentially performed on histologic samples; however, whenever histology is not available or is inadequate, molecular testing requests are referred to cytopathology 22 .…”

The continuing role of breast fine‐needle aspiration biopsy after the introduction of the IAC Yokohama System For Reporting Breast Fine Needle Aspiration Biopsy Cytopathology

“…Among these are the difficulty in ensuring the availability of onsite cytopathologists during the procedure and the inadequate training of physicians (radiologists or surgeons) to adequately perform FNAB and to handle biopsied material 4,15 . Such shortcomings have frequently resulted in poorly prepared specimens with high rates of inadequate samples 19,20 . Another major reason is that FNAB is losing ground to CNB particularly in the setting of mammographic screening 4 .…”

Diagnosis of solid tumors in infants by fine‐needle aspiration cytology: 5 years retrospective study from a tertiary care oncology center in South India

“…These abnormalities can be detected by molecular methods like Fluorescence in situ hybridization (FISH), Next‐generation sequencing (NGS), Nucleic acid microarrays, comparative genomic hybridization, PCR, and RT‐PCR 23 . DNA yield and RNA preservation for molecular tests are superior in fine needle aspirate than formalin‐fixed core needle biopsy 24 . Either CBs or direct FNA material (based on cellularity of aspirate) can be utilized for diagnostic and prognostic relevant molecular testing, particularly in resource‐rich settings where these tests are of the standard of care.…”