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26371 Guardant 360

Guardant 360
Test Code: GUARDSO
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 RequiredSpecimen TypePreferred Container/TubeAcceptable Container/TubeSpecimen VolumeSpecimen 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.  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 TypeTemperatureTime
​Whole Blood​Ambient (18 - 25°C)​7 days.  Specimen must be received at the reference laboratory within 7 days from the time of collection.
Rejection Criteria

Refrigerated specimen

Frozen specimen

Performing Laboratory Information
Performing LocationDay(s) Test PerformedAnalytical TimeMethodology/Instrumentation
​Guardant Health, Inc.​Sunday through Saturday​10 days​Digital next-generation DNA sequencing
Reference Lab
Guardant Health, Inc.
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.

Reference Range Information

An interpretive report will be provided

Interpretation

​An interpretive report will be provided

Outreach CPTs
CPTModifier
(if needed)		QuantityDescriptionComments
​​​​​
Ordering Applications
Ordering ApplicationDescription
​COM​Guardant 360
​Cerner​Guardant 360
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Fasting RequiredSpecimen TypePreferred Container/TubeAcceptable Container/TubeSpecimen VolumeSpecimen 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

​Collect sample by venipuncture, completely filling the two 10.0 mL blood collection tubes provided in the Guardant 360 kit.  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 TypeTemperatureTime
​Whole Blood​Ambient (18 - 25°C)​7 days.  Specimen must be received at the reference laboratory within 7 days from the time of collection.
Rejection Criteria

Refrigerated specimen

Frozen specimen

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.
Reference Range Information

An interpretive report will be provided

Interpretation

​An interpretive report will be provided

For more information visit:
Performing Laboratory Information
Performing LocationDay(s) Test PerformedAnalytical TimeMethodology/Instrumentation
​Guardant Health, Inc.​Sunday through Saturday​10 days​Digital next-generation DNA sequencing
Reference Lab
Guardant Health, Inc.
For billing questions, see Contacts
Outreach CPTs
CPTModifier
(if needed)		QuantityDescriptionComments
​​​​​
For most current information refer to the Marshfield Laboratory online reference manual.