The Application Landscape Of The No. 1 Core Biopsy Needle in Neoplastic And Non-Neoplastic Diseases

Jun 16, 2026

https://cloud.merit.com/catalog/IFUs/404781101.pdf

The "No. 1" core biopsy needle, capable of acquiring high-quality soft tissue cores, has become an indispensable tool in modern pathological diagnosis. Its utility spans multiple disciplines, including oncology, rheumatology, infectious diseases, and more, serving as the critical bridge connecting imaging abnormalities to definitive pathological conclusions.

Core Application Domain: Oncological Diagnosis

This represents the most widespread application of the No. 1 core needle. For imaging-detected lesions such as BI-RADS category 4 or higher breast nodules, suspicious thyroid nodules (especially when Fine Needle Aspiration results are indeterminate), hepatic occupying lesions, solid renal masses, suspicious areas in the peripheral zone of the prostate, and deep soft tissue sarcomas, the No. 1 core needle biopsy is the preferred method for definitive characterization.

  • Manifestation of Advantages:​ Compared to fine needle aspiration, the No. 1 core needle provides sufficient tissue for histological grading​ (e.g., Nottingham grading for breast cancer), immunohistochemical staining​ (e.g., assessment of ER/PR/HER2/PD-L1 expression), and genomic sequencing​ (e.g., detection of EGFR, ALK, ROS1 mutations). This information directly dictates the selection of targeted therapies and immunotherapy regimens.

Non-Neoplastic Disease Diagnosis

The value of the No. 1 core needle extends far beyond cancer diagnosis.

  • Inflammation and Autoimmune Diseases:​ For cryptogenic chronic hepatitis, cirrhosis, renal involvement in Systemic Lupus Erythematosus (requiring cautious ultrasound guidance), and Primary Biliary Cholangitis, the No. 1 core needle biopsy provides histopathological evidence to determine the degree of inflammatory activity, fibrosis staging, and characteristic pathological changes (e.g., "onion-skin" lesions).
  • Infectious Diseases:​ When conventional cultures and serological tests fail to identify pathogens, performing a No. 1 core needle biopsy on abscess walls, granulomatous lesions, or lymphadenopathy of unknown origin can yield sufficient tissue for special staining (e.g., Acid-Fast Bacilli stain, Periodic Acid-Schiff stain), microbiological culture with sensitivity testing, and even metagenomic Next-Generation Sequencing (mNGS). This enables the identification of Mycobacterium tuberculosis, fungi, or rare pathogens.
  • Benign Tumors and Hyperplasia:​ For benign lesions such as lipomas, hemangiomas, and neurofibromas, if imaging features are atypical or the lesion exhibits rapid growth, the No. 1 core needle biopsy can provide a definitive benign diagnosis, obviating the need for unnecessary surgical excision.

Challenges and Countermeasures in Special Anatomical Sites

When performing No. 1 core needle biopsies in high-risk zones such as the lungs, pancreas, or retroperitoneum, real-time CT or ultrasound guidance combined with a coaxial cannula technique​ is mandatory. The coaxial cannula allows for multiple sampling passes after a single insertion, reducing damage to normal tissue and the risk of needle tract seeding. For lesions adjacent to major vessels or critical nerves, meticulous pre-operative path planning and control of patient respiratory motion are paramount.

Conclusion

With its exceptional tissue acquisition capability, the No. 1 core biopsy needle not only serves the precise subtyping of cancer but also stands as a powerful instrument for solving the diagnostic dilemmas of complex non-neoplastic diseases.

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