Solid Tumor NGS Panel (22 genes)

Test ID: M Solid Tumor NGS CPT Code: N/A

Biopharma: This test is available for use in clinical trials or research purposes only.

Expected Turnaround Time

14 days
Stated turn-around-times (TATs) are for clinical use only and subject to change based on biopharma protocol requirements. Final TATs will be specified in the biopharma study contract.

Clinical Information

This assay is an FDA-approved next generation sequencing assay designed to detect single nucleotide variants (SNVs), insertions and deletions in 22 genes involved in solid tumor malignancies, including: AKT1, ALK, BRAF, CTNNB1, DDR2, EGFR, ERBB2, ERBB4, FBXW7, FGFR1, FGFR2, FGFR3, KRAS, MAP2K1, MET, NOTCH1, NRAS, PIK3CA, PTEN, SMAD4, STK11, and TP53.

Specimen Requirements

Paraffin Embedded Tissue Block: FFPE Block, 10% NBF Fixed
Paraffin Embedded Tissue Slides: 5 slides or scrolls (minimum 5-10 μM), 10% NBF Fixed

Specimen Stability

Indefinite at ambient temperature (15-25°C)

Storage Requirements

15°C to 25°C

Shipping Conditions

Ambient

Shipping Recommendations

AMBIENT, Use a refrigerated (NOT FROZEN) gel pack in the shipment to protect from extreme temperatures. Separate gel pack from specimen.

Specimen Rejection Criteria

Improper specimen labeling; Insufficient tissue; Insufficient tumor burden; Insufficient DNA isolated

Test Details

Test Method

Next Generation Sequencing (NGS)

Methodology Category

Molecular

Regulatory Status

IVD, FDA-Approved Companion Diagnostic (CDx)

Special Considerations

FFPE block preferred; unbaked slides acceptable.
Include a surgical pathology report with the sample