Guardant 360 CDx (Sendout)

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General Information

Lab Name
Guardant 360 CDx (Sendout)
Lab Code
R360CD
External Test Id
Guardant360® CDx
Description

Test Information: Guardant360® CDx is a liquid biopsy companion diagnostic that analyzes circulating tumor DNA (ctDNA) to identify actionable genomic alterations and match patients to targeted therapies.

Ordering Requirements:

  • A Guardant360 CDx Kit is required for testing. Availability will vary by collection site.
    • FHCC: Kits are stocked in the lab and Care Neighborhood Clinics. Contact FHCC Supply Chain if kits are not available in the clinic.
    • UW-MT (Montlake), UW-NW (Northwest), HMC (Harborview), UWPC (Primary Care), UW Ambulatory (Roosevelt, SLU, Eastside): Kits are not provided by Lab Medicine. Guardant kits must be obtained by clinic staff and accompany the patient to blood draw.
  • This test is available for patients within the UW Medicine system only. Orders and results are interfaced directly with Epic.
References
Components
Code Name
RCDSP Guardant 360 CDx Collection
RCDTR Guardant 360 CDx Tracking
RGSTK1 Guardant Streck Tube 1
RGSTK2 Guardant Streck Tube 2

Interpretation

Method

Next-generation sequencing (NGS)

Reference Range
See individual components
References

Ordering & Collection

Specimen Type
Blood
Collection

Collection Requirements: A Guardant360 CDx kit is required for testing. Availability will vary by collection site.

  • FHCC: Kits are stocked in the lab and Care Neighborhood Clinics. Contact FHCC Supply Chain if kits are not available in the clinic.
  • UW-MT, UW-NW, HMC, UW Primary Care, UW Ambulatory: Kits are not provided by Lab Medicine. Kits must be obtained by clinic staff and accompany the patient to blood draw. To order, contact Guardant Health directly via phone (855-698-8887) or email (clientservices@guardanthealth.com).

Collection Instructions:

  • Collect 2 x 10 mL Streck Cell-Free DNA BCT® (tan) tubes from a Guardant360 CDx Kit. Streck tubes not sourced from the appropriate Guardant kit will be rejected.
  • 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 samples.
  • Deliver the samples and the kit to the lab.

Note: Underfilling of tubes with less than 5 mL of blood may lead to incorrect analytical results or poor product performance.

Handling Instructions

Outside Laboratories: This test is available to patients within the UW Medicine system only. If desired, clients should arrange for testing directly with Guardant Health.

Quantity
Requested: 20 mL whole blood in 2 x Streck tubes
Minimum: 3-5 mL whole blood each in 2 x Streck tubes

Processing

Receiving Instructions

Store and transport whole blood samples at ambient temperature.

  • HMC and UW-NW SPS: Forward samples and kit to UW-MT for sendout.

FHCC SPS/UW-MT Sendouts:

  • Package samples at ambient temperature using the provided kit.
    • Guardant does not require a copy of the Epic requisition for interface orders.
  • Samples may be shipped on Friday for Saturday delivery.

FHCC/CAST:

  • Print pending FGHSO/UGHSO worksheets depending on collection site.
  • Confirm that samples have been sent, then complete the pending RCDTR (Guardant 360 CDx Tracking) test with GHRSO.

Stability: Ambient (required): 7 days; Refrigerated: Unacceptable; Frozen: Unacceptable.

Misc Sendout

Performance

Lab Department
Sendouts(SO)
Frequency
Turnaround Time: 5 days from sample receipt at Guardant Health.
Available STAT?
No
Performing Location(s)
Sendout Guardant Health
855-698-8887

505 Penobscot Drive
Redwood City, CA 94063

Email: clientservices@guardanthealth.com
Fax: 888.974.4258

Billing & Coding