Signatera (Sendout)

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General Information

Lab Name
Signatera Inhouse Collection
Lab Code
RSIGNA
Epic Ordering
Signatera (Sendout) Panel (O366383)
External Test Id
Signatera™
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.

Ordering Requirements: A Natera Signatera™ kit is required for testing. Providers should arrange with Natera to obtain kits and have the patient bring the kit to Phlebotomy for collection.

Synonyms
Circulating Tumor DNA Detection, Natera, Signatera ctDNA
Components

Interpretation

Method

mPCR-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 Natera Signatera™ kit. Natera will not accept other tubes.

Additional Draw Instructions:

  • 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 from Natera Signatera™ kit
minimum: 20 mL whole blood in Streck tubes and 6 mL EDTA whole blood from Natera Signatera™ kit

Processing

Processing

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 RSIGTR (Signatera Sample Tracking) test.

UW-MT Sendouts:

  • 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 RSIGNA order by entering NATSO for the pending RSIGTR (Signatera Sample Tracking) component.
  • Results will file directly from Natera to Epic via interface.

Performance

LIS Dept Code
Sendouts (SO)
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 Clinical Support:

  • Phone: 650.489.9050
  • Email: signateracc@natera.com
Frequency
Turnaround Time: 3-4 weeks from sample receipt.
Available STAT?
No

Billing & Coding

CPT codes
Billing Comments

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

LOINC
30896-5