Guardant 360 CDx (Sendout)

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.

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.

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.