Watson Genomics from Quest, Core

Test Code
93234

CPT Codes
81445

Includes
AKT1, AKT2, ALK, AR, AURKA, BAP1, BRAF, BRCA1, BRCA2, CDKN2A, CDKN2B, CTNNB1, DDR2, EGFR, EP300, ERBB2, ERBB3, ERBB4, ESR1, FGFR1, FGFR2, FGFR3, FGFR4, FLT3, HRAS, IDH1, JAK2, KDR, KIT, KRAS, MAP2K1, MET, MTOR, MYC, MYCN, NRAS, NTRK1, PDGFRA, PDGFRB, PIK3CA, PTCH1, PTEN, RET, ROS1, TERT, TMPRSS2, TP53, TSC1, VHL
MSI of 5 loci may be performed dependent upon specimen(s) submitted.

Preferred Specimen
Formalin-fixed paraffin-embedded tissue block and 7 mL whole blood collected in an EDTA (lavender top) or Streck tube; 1 slide of 4 micron section with H&E staining

Minimum Volume
(1) 4 micron unstained slide • 2 mL whole blood

Other Acceptable Specimens
Formalin-fixed paraffin-embedded FNA or 10 unstained slides of formalin-fixed paraffin-embedded tissue and whole blood collected in an EDTA (lavender top) tube or 50 ul of 10 ng/ul extracted DNA

Instructions
Blood is not acceptable if submitted by itself.

For normal sample: Please submit either blood (EDTA or Streck tube) or FFPE of normal tissue.

For whole blood: Either EDTA or Streck tube, collection time and date should be entered on tube and requisition form.

For tumor only: Please submit FFPE (Formalin-fixed Paraffin-embedded), block or slides. If you do not have access to the specimen, please include a pathology report and Quest will retrieve the specimen on your behalf.

For submission of paraffin block: Tumor tissue type and block ID are required on the requisition form. A pathology report must be submitted. Sample must contain > or = 10% tumor content.

For paired analysis: Please submit FFPE block or slides of tumor tissue and whole blood together; or FFPE with both tumor and normal tissue must be submitted together. If you do not have access to the FFPE specimen, please include a pathology report and Quest will retrieve the specimen on your behalf.

Unstained slides of formalin-fixed paraffin-embedded tissue: Need 10 slides of 10 micron section for testing and 1 slide of 4 micron section with H&E staining.

Extracted DNA: For tumor only: Extracted DNA must come from FFPE block or slides of tumor tissue.

For paired analysis: Extracted DNA must indicate it comes from FFPE block (or slides) of tumors and from whole blood or FFPE of normal. Ship immediately to maintain sample stability.

Transport Temperature
Room temperature

Specimen Stability
Paraffin embedded tissue block/ FNA 
Room temperature: 2 years
Refrigerated: 2 years
Frozen: Unacceptable

Whole blood
Room temperature: 7 days
Refrigerated: 14 days
Frozen: Unacceptable

H&E slide 4 Micron/Unstained slides
Room temperature: Indefinite
Refrigerated: Indefinite
Frozen: Unacceptable

Extracted DNA
Room temperature: 14 days
Refrigerated: 90 days
Frozen: Indefinitely

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Hemolysis • Baked slides

Methodology
Next Generation Sequencing/Illumina NextSeq

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Sets up 1 day a week.

Report Available
Reports in 20 days.

Clinical Significance
This multiplex panel will allow physicians to choose the most appropriate therapy for their patients based on the alterations found in the individual's tumor sample DNA. Guidelines exist for using results from many of these genes for selection of FDA approved therapies. By testing for other genes the physician can become aware of alternative treatments available to the patient based on presence of mutations in other genes the physicians might not have considered. Additional genes indicate prognosis of those patients with mutations, thus allowing physicians and patients to choose more or less aggressive therapies. Finally, mutations found in additional genes will qualify patients for ongoing or planned clinical trials



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.