One-step nucleic acid amplification (OSNA): where do we go with it?

Area of Science:

• Oncology
• Molecular Diagnostics
• Surgical Pathology

Background:

• The one-step nucleic acid amplification (OSNA) assay, measuring cytokeratin 19 (CK19) mRNA, was developed for intraoperative assessment of breast cancer lymph node metastases.
• Recent clinical trials (IBCSG 23-01, ACOSOG Z0011, AMAROS) indicate that further axillary dissection is unnecessary for node-positive sentinel lymph nodes, reducing the need for intraoperative assessment.

Purpose of the Study:

• To review existing studies on the OSNA assay and explore its potential future applications in cancer surgery.
• To evaluate OSNA's performance as an alternative to pathological assessment for lymph node metastasis detection.

Main Methods:

• A literature search was conducted on PubMed for articles on OSNA published before June 2016.
• Method comparison studies between OSNA and pathological assessment for lymph node metastasis in various cancers were reviewed.

Main Results:

• Pooled analysis of breast cancer studies showed OSNA has high specificity (94.8%), a high concordance rate (93.8%), and a high negative predictive value (97.6%).
• Similar high performance was observed in multicenter studies for gastric, colorectal, and lung cancers.
• OSNA demonstrates potential as a viable alternative to pathological assessment for lymph node metastasis detection.

Conclusions:

• OSNA is a highly accurate method for detecting lymph node metastasis across multiple cancer types.
• Further large-scale, multicenter prospective studies are required to establish OSNA's superiority over pathological assessment in predicting prognosis.
• Technical advancements are crucial for OSNA to become a new standard in cancer testing, potentially replacing pathological examination.