Requisition Form Information
What is the appropriate action to take if the test menu section is not filled out on the requisition form? Can you send a SR?
Add order exception & send to PRS for follow up
You can send the SR but not submit to the lab until verified.
What is the age limit for our CM test?
12yrs old
Age 12-17 will automatically have a report disclaimer added
Define Breslow's Depth
Measurement in mm of how thick the primary tumor is, regardless of its Clark Level. It is measured from the top layer of the skin to it's deepest point.
What is the purpose of our SEQ test?
Our Sequencing Add-On is a 3-gene next-generation sequencing (NGS) test that detects somatic mutations in BRAF, NRAS, and KIT—genes critical in informing therapy choices for melanoma patients in adjuvant and metastatic settings, including clinical trial eligibility.
What type of test is DecisionDx-Melanoma and what is it designed to do?
Gene expression profile test (31 genes) that provides comprehensive, personalized results to guide risk-aligned management decisions for patients with stage I-III cutaneous melanoma regarding a patient's risk of recurrence and/or metastasis and likelihood of sentinel lymph node positivity.
Define clinically palpable nodes
Clinically palpable lymph nodes are often, but not always, indicative of underlying pathology like infection, inflammation, or malignancy.
What is the validated timeframe for samples to be eligible for testing?
≤3 years since the date of the procedure (DOC)
Exceptions can be made for cases diagnosed between 3-5 years IF the physician is willing to provide written justification for testing.
Patient with a prior Class 2 on a separate melanoma (<3 years) require written rationale for clinical utility.
Define Mitotic Rate
Mitosis is the process in which one mature cell divides into two identical cells. The pathologist counts the number of actively dividing cells that they see.
Can SEQ testing be ordered by itself?
Sequencing is rarely ordered by itself, it can occur if a clinician adds it after an initial GEP test or if a new clinician orders Sequencing after a previous GEP-only result. These instances are considered SEQ Only cases. Special handling instructions and alerts are in place to guide Junior Specimen Processors and Specimen Processors to check in Sequencing materials appropriately without expecting both test packets if ordered by itself.
What are the possible report results for a CM order?
Class 1A, Class 1B/2A, Class 2B, MGF, QC Fail, QNS
Define In-transit metastasis
In-transit metastasis in cutaneous melanoma refers to tumor deposits spreading through lymphatic channels, appearing as subcutaneous or dermal nodules between the primary tumor and the first regional lymph node
Scenario: Provider submits an order with an eligible Biopsy AND eligible Excision pathology report for the SAME primary melanoma
We will test the lesion that is most concerning with the higher Breslow depth
If we only receive the less concerning tissue, we should hold and request the more concerning lesion. No site confirmation needed, we should just check in what tissue we received and hang the order pending additional material for the deeper biopsy.
Define Ulceration
The breakdown or loss of the top layer of the skin (epidermis). The presence or absence of this is determined by the pathologist and is associated with a worse prognosis. Patients who report bleeding from their melanoma often have ulceration in the biopsy.
How much tissue do you request for a GEP/SEQ order and what is the break down of amount of tissue needed for each test?
13uns 2 H&E OR Shared Block
GEP = 9uns 1 H&E
SEQ= 5uns & 1 H&E
Explain the process for patient orders with microsatellites present on the pathology report
We need to notify the pathologist assessing the H&E for tumor content to ensure he/she is marking an area that contains primary tumor tissue ONLY
-Notate in LIMS the presence of microsatellites on the pathology report.
-Update Nodal Staging to N1c
-Add MICROSATELLITE Special Handling Form to the Requisition Packet
-Include Email Template in Requisition Packet for the SP who receives the tissue (Template Provided)
-Upon receipt of the tissue, SP will notify the slide scanner (via email) to include the email notification to the pathologist who is reading H&E’s that day.
What is the appropriate action to take if the SLNB information is missing from the requisition form
1) Verify if the DOC was within the last 2 weeks or not
2) If yes, no action required
3)If no, send a courtesy fax for the SLNB, in-transit mets and palpable nodes information
In what instance(s)can we proceed with testing a Melanoma In-Situ lesion?
If the lesion is 75% regressed or path report remarks “Extensive Regression” - Cannot accept treatment letter for this, must be present on path
Define Tumor-Infiltrating Lymphocyte (TILS)
TILS describe the patient's immune response to the melanoma. Pathologists look to see whether there are lymphocytes within the melanoma. TILS appear to indicate that the immune response has recognized the melanoma cells as abnormal and is trying to move into the melanoma to attack it. Some studies suggest that the presence of increasing TILS may be associated with a better prognosis.
What is the TAT for Sequencing testing?
15 business days
Define Transected Base and identify the 4 accepted terms to indicate this in the test order.
When a biopsy (often a shallow shave) cuts through the tumor, leaving cancer cells at the deep margin, preventing accurate measurement of Breslow thickness. While it rarely impacts long-term survival, it necessitates re-excision to determine tumor depth and can increase the likelihood of sentinel lymph node biopsy (SLNB).
1. At least
2. Positive Deep Margins
3. Transected Base/Focally transected
4. Incompletely Excised
How is the SLNB positivity risk score calculated?
By integrating the 31-GEP class score with clinicopathologic factors:
Ulceration
Age
Breslow Thickness
Mitotic Rate
DecisionDx-Melanoma provides precise and personalized risk predictions for likelihood of SLNB positivity.
Scenario: You receive a CM order for a patient that has a previous class 2 results >3 years ago. Can we proceed and do we need a letter of rationale?
If the previous Class 2 was issued more than 3 years ago we can proceed with testing the new primary without rationale
Make notes of prior test:
“Patient had prior melanoma testing in February 2021 on the R arm which resulted in a class 2A. Proceeding with testing without a rationale as this test was completed >3 years ago”
Define Microsatellites/Satellite lesions
Microscopic satellites (microsatellites) in primary melanoma are defined as one or more discontinuous nests of neoplastic melanocytes measuring more than 0.05 mm in diameter that are clearly separated from the main invasive component of the melanoma Also called "local metastasis". They are either present or absent. Can be seen both microscopically and with the naked eye and are associated with a worse prognosis.
Scenario: I received a Sequencing order, but the GEP is currently in progress. How should we proceed?
See Confluence: https://castlebiosciences.atlassian.net/wiki/x/AQCLRg
Scenario #4
You receive a CM order for a patient that has a prior MyPath order in Exemplar. Explain the process to go from MPM to CM
See Confluence Job Aide