Signatera & Altera (Sendout)

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General Information

Lab Name
Signatera and Altera, Inhouse collection
Lab Code
RSIALT
Epic Name
Signatera & Altera (Sendout)
External Test Id
Signatera™ and Altera™
Description

Test Information: Signatera™ is a mPCR-NGS assay for detection and quantification of circulating tumor DNA (ctDNA) in the plasma of patients previously diagnosed with cancer. Individual-specific mutation signatures are identified by upfront tissue and matched normal whole exome sequencing. Altera™ offers a whole exome and transcriptome based approach for Comprehensive Genomic Profiling (CGP) with boosted >500X coverage for 440 medically important genes.

    Ordering Requirements: A Natera Signatera and Altera™ kit is preferred for testing, but not required. If patients will be drawn at a site that does not stock kits, providers may select the "Lab Collect - Send Kit" option in the Signatera & Altera™ Epic order to arrange for a kit to be shipped directly to the patient prior to collection.

    Synonyms
    Altera Genomic Profile, Natera, Signatera ctDNA
    Components
    Code Name
    RSIASP Signatera and Altera Collection

    Interpretation

    Method

    NGS

    Reference Range
    See individual components

    Ordering & Collection

    Specimen Type
    Blood
    Collection

    Collect 2 x 10 mL Streck Cell-Free DNA BCT® tubes (mottled black and tan) and 1 x 6 mL LAVENDER TOP (EDTA) tube from a Natera Signatera and Altera™ kit.

    • If Signatera and Altera™ kits are not available at the collection site, lab staff may use Streck and Lavender top (EDTA) tubes on hand. DO NOT COVER UP THE EXPIRATION DATE ON THE TUBE.
    • Fill all tubes completely and mix by gently inverting 8-10 times. Do not shake vigorously.
    • Walk samples to the laboratory after collection. Do not transport via pneumatic tube system, as this may compromise the Streck collection tubes.
    • When delivering samples to the lab, include the kit and the Natera requisition that prints from Epic.
    • Clinics should not rely on DLMP to provide kits due to unknown volume of orders.
    Handling Instructions

    Outside Laboratories: Test available to UW Medicine patients only.

    Quantity
    Requested: 20 mL whole blood in Streck tubes and 6 mL EDTA whole blood
    Minimum: 20 mL whole blood in Streck tubes and 6 mL EDTA whole blood

    Processing

    Receiving Instructions

    Store and transport whole blood samples at room temperature.

    • HMC and UW-NW: Forward samples and kit to UW-MT for sendout.
    • Fred Hutch: Send samples to Natera using provided kit. Close the order after sendout by entering NATSO for the pending RSIATR (Signatera and Altera Sample Tracking) test.

    UW-MT Sendouts:

    • If samples have not been sourced from a Natera kit, ensure that the expiration dates on all of the tubes are visible.
    • Package samples along with the Natera requisition (printed from Epic) and ship at room temperature using the provided kit.
    • Samples may be shipped on Friday for Saturday delivery.

    Stability:

    • Lavender Tubes: Ambient (required): 14 days; Refrigerated: Unacceptable; Frozen: Unacceptable.
    • Streck Tubes: Ambient (required): 9 days; Refrigerated: Unacceptable; Frozen: Unacceptable.

    CAST:

    • Print a pending UNATSO worksheet.
    • Use Sunquest 'Audit Trail' to confirm that the sample has been sent out.
    • Close the RSIALT order by entering NATSO for the pending RSIATR (Signatera and Altera Sample Tracking) component.
    • Results will file directly from Natera to Epic via interface.
    Misc Sendout

    Performance

    Lab Department
    Sendouts(SO)
    Frequency
    Turnaround Times: Signatera: 3 - 4 weeks; Altera: 2-3 weeks.
    Available STAT?
    No
    Performing Location(s)
    Sendout Natera

    201 Industrial Road
    San Carlos, CA 94070

    Phone Numbers:

    • 650-273-4468 (Organ Health)
    • 844-778-4700 (Women's Health)
    • 650-489-9050 (Oncology)
    Other Locations/Notes

    Signatera & Altera Clinical Support:

    • Phone: 650.489.9050
    • Email: signateracc@natera.com

    Billing & Coding

    LOINC
    30896-5
    Billing Comments

    No institutional billing. Patient self-pay or direct insurance billing only.