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Test Code GUARDSO Guardant 360

Important Note

For internal orders only.  Not available to outreach clients.

Ordering provider must complete a requisition form (paper copy provided in collection kit) to accompany specimen for send out to referral lab.

Useful For

  • Advanced cancer patients requiring more complete genotyping.
  • Tissue biopsy is not sufficient in quantity or quality, or tissue is unobtainable at diagnosis or progression.
  • Progression of cancer as documented by functional status, imaging, or tumor markers.
  • Archived tissue older than 6 months.
  • One or more lines of therapy or intervention since last biopsy.
  • Time to treatment is critical and decision needed in 2 weeks or less.
  • Patient prefers non-invasive genomic profiling or unwilling to submit to invasive biopsies.

Specimen Requirements

Fasting Required Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
No Whole Blood

Guardant 360 Kit: Supplied in Specimen Lab Processing Department.

Refer to the Kit and the Collection Processing Instructions (below).

   2 tubes; 10 mL each tube    

Collection/Processing Instructions

Collect sample by venipuncture, completely filling the two 10.0 mL blood collection tubes provided in the Guardant 360 kit (Guardant 360 CDx kit is utilized for this test).  Mix by gentle inversion 10 times. 

 

*DO NOT REFRIGERATE OR FREEZE BLOOD SAMPLES* 

 

Complete the provided test requisition and barcode labels.  Place a label on each tube with the barcode in the vertical position and also on the requisition. 

 

The completed requisition can be placed into the outer pocket of the specimen bag and the blood tubes placed into the foam.  Place the foam into the specimen bag and ensure the bag is closed.  Place filled specimen bag into the box on top of one of the gel packs.  **DO NOT FREEZE GEL PACKS.  USE AS IS.**  Place the 2nd gel pack on top of the specimen bag and close the box.  Place the kit into the preprinted FedEx Clinical Pak for shipping.  Proper insulation may be required for shipment during extreme temperature conditions.

 

Specimen must be received at the reference laboratory within 7 days from the time of collection.

Specimen Stability Information

Specimen Type Temperature Time
Whole Blood Ambient (18 - 25C) 7 days.  Specimen must be received at the reference laboratory within 7 days from the time of collection.

Rejection Criteria

Refrigerated specimen

Frozen specimen

Test Information

Guardant360 detects circulating tumor DNA (ctDNA) in blood specimens of advanced solid-tumor cancer patients.  It identifies all actionable somatic genomic targets recommended by leading guidelines with a single blood draw.

Interpretations

An interpretive report will be provided

Reference Range Information

An interpretive report will be provided

Performing Laboratory Name

Guardant Health, Inc.

Referral Laboratory Information

Address Telephone Website Link Marshfield Lab Account #

505 Penobscot Drive

Redwood City, CA 94063

 855-698-8887

https://guardanthealth.com

  

Performing Information

Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
Guardant Health, Inc. Sunday through Saturday 10 days Digital next-generation DNA sequencing

CPT Codes

CPT Modifier
(if needed)		 Quantity Description Comments
         

Ordering Applications

Ordering Application Description
COM Guardant 360
Cerner Guardant 360