The SHOX2 and RASSF1A DNA Methylation Detection Kit is a real-time fluorescence PCR (real-time PCR) assay for the qualitative detection of methylated human SHOX2 and RASSF1A gene promoters in bronchoalveolar lavage fluid (BALF). Using a multiplex bisulfite-conversion workflow with TaqMan probe detection, the kit simultaneously interrogates both methylation biomarkers in a single closed-tube reaction — providing a non-imaging, molecular adjunct to cytology for the differential diagnosis and early detection of lung cancer.
WHY SHOX2 AND RASSF1A METHYLATION?
DNA methylation of tumor-suppressor and homeobox gene promoters is an early and nearly universal event in lung carcinogenesis, making methylated DNA a highly sensitive biomarker for early lung cancer detection that outperforms conventional protein markers. Two methylation markers stand out for clinical use:
• SHOX2 (Short Stature Homeobox 2): a homeobox transcription factor with aberrant promoter methylation found in multiple solid tumors, including lung, breast, and kidney cancers. SHOX2 methylation accurately distinguishes benign from malignant lung lesions and serves as both an early detection marker and an independent prognostic marker for non-small cell lung cancer (NSCLC).
• RASSF1A (Ras Association Domain Family 1A): a tumor-suppressor gene involved in transcription regulation, signal transduction, cytoskeleton organization, cell cycle, adhesion, and apoptosis. Promoter hypermethylation — together with loss of heterozygosity and chromosomal deletion — is the principal mechanism silencing RASSF1A in tumors.
Combined as a dual-marker panel, the two markers deliver 75-81% sensitivity and 90-97% specificity in BALF. Methylation is detectable in asymptomatic patients before clinical symptoms appear, making this a powerful tool for early lung cancer screening and for resolving indeterminate cytology.
KEY FEATURES
• Dual-marker methylation panel (SHOX2 + RASSF1A) in a single multiplex real-time PCR reaction
• Bisulfite-conversion chemistry distinguishes methylated from unmethylated cytosines with high specificity
• Three-color fluorescent detection: FAM (methylated RASSF1A), VIC/HEX (methylated SHOX2), Cy5 (internal standard)
• Closed-tube workflow minimizes contamination risk
• High sensitivity: limit of detection ≤250 copies/test
• Excellent precision: coefficient of variation (CV) ≤5%
• CE marked, for professional in vitro diagnostic use
CLINICAL VALIDATION
Multicenter clinical studies totaling 1,000 cases across three hospitals supported NMPA (formerly CFDA) approval in November 2017. In BALF the dual-marker panel achieves 75-81% sensitivity and 90-97% specificity; in FFPE tissue specimens, 89.8% sensitivity and 90.4% specificity. The kit is recognized in the molecular diagnostic workflow as a sensitive adjunct to BALF cytology, particularly when cytology is inconclusive.
SPECIFICATIONS
• Specimen type: human bronchoalveolar lavage fluid (BALF), bisulfite-converted before PCR
• Methodology: bisulfite conversion + multiplex TaqMan-probe real-time fluorescent PCR
• Packaging: 20 tests/kit
• Compatible instruments: real-time PCR systems with FAM, VIC/HEX, and Cy5 channels (e.g., ABI 7500)
• Storage: ≤ -20°C, protected from light; shelf life 9 months; maximum 5 freeze-thaw cycles
• Detection channels: FAM (RASSF1A), VIC/HEX (SHOX2), Cy5 (internal standard)
TARGET USERS
Clinical laboratories, hospital pulmonary and thoracic surgery departments, bronchoscopy centers, and molecular diagnostic centers performing lung cancer workups — particularly when BALF cytology is indeterminate.
Note: For in vitro diagnostic use only. Methylation results are for clinical reference and should be interpreted by a qualified clinician together with cytology, imaging, and other clinical findings.
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