50SEQ with FISH : 1015936

Message
Please provide most recent Pathology report.

Test Code
MDFCPNGS50WF or 1015936

Alias/See Also
50SEQ by NGS

CPT Codes
81445, 88377x4, 88360

Includes
This panel includes 50SEQ Panel, ALK by FISH, ROS1 by FISH, c-MET by FISH, RET by FISH, and PD-L1 by IHC.

50SEQ Panel Components: AKT1, ALK, APC, ATM, BRAF, CDH1, CDKN2A, CSF1R, CTNNB1, EGFR, ERBB2(HER2), ERBB4, ESR1, FBXW7, FGFR1, FGFR2, FGFR3, FLT3, GNA11, GNAQ, GNAS, HNF1A, HRAS, IDH1, IDH2, JAK2, JAK3, KDR, KIT, KRAS, MAP2K1, MET, MLH1, NOTCH1, NRAS, PDGFRA, PIK3CA, PIK3R1, PTEN, PTPN11, RB1, RET, ROS1, SMAD4, SMARCB1, SMO, SRC, STK11, TP53, VHL.

med fusion can deliver your SEQ report by fax or eLabs Results Portal. Please contact your med fusion representative to make them aware of your desired delivery and if you need access to the results portal. The results portal will provide links for additional therapy and clinical trial information associated with the patient’s molecular profile.
If you have any further questions, additional needs, or would like to speak with med fusion’s scientific staff, pathologists, or client services, please contact us at 972-966-7050/844-966-7050.

Instructions
Tissue.

Transport Container
Paraffin embedded Tissue accompanied by a circled H & E slide indicating the area to be examined: submit in sterile biohazard plastic bag. Slides: submit 22 FFPE slides and H & E slide in slide holder. Specimen to be tested must contain a minimum of 20 percent tumor.

Transport Temperature
Paraffin embedded Tissue: Ambient or on ice pack in summer; Slides: Ambient.

Specimen Stability
Paraffin embedded tissue: Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Decalcified tissue specimen.

Methodology
Next Generation Sequencing; Fluorescence in situ hybridization; Immunohistochemistry

Setup Schedule
Monday & Wednesday

Report Available
8-10 days

Limitations
Laboratory test results should always be considered in the context of clinical observations. This test was developed and its performance characteristics determined by med fusion. It has not been cleared or approved by the U.S. Food and Drug Administration
(FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments
of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.

ALK gene rearrangement by FISH is an FDA approved test.

Reference Range
An interpretive report will be provided.

Clinical Significance
The 50-gene solid tumor panel (50SEQ) with concurrent FISH and PD-L1 is intended to aid the oncologist in developing a treatment plan for patients with refractory and rare tumors in situations where standard of care therapies have failed, or no standard of care exists for the disease.

Performing Laboratory
med fusion



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.