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Test Code GCDXSO Guardant 360 CDX

Important Note

For internal ordering 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

Liquid biopsy that analyzes genetic changes in the tumor by scanning DNA that tumors have shed into the blood. Unlike traditional tissue biopsies, liquid biopsies are less invasive and quicker.

 

It is approved for people with solid cancers (such as long or prostate cancer), but not for blood cancers. Specifically, it is used for patients with non-small cell lung cancer. 

 

Detects gene mutations found in circulating cell-free DNA. By identifying these mutations, doctors gain valuable information about cancer-related genetic changes in a specific patient. 

 

The test results help doctors decide if patients with non-small cell lung cancer are eligible for treatment with specific drugs.

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 CDX Kit: Supplied in Specimen Lab Processing Department.
 		 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 CDx 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 spcimen 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 recived at the reference laboratory within 7 days from the time of collection. 

Specimen Stability Information

Specimen Type Temperature Time
Whole Blood Ambient 7 days

Rejection Criteria

Refrigerated specimen

Frozen specimen

Test Information

Guardant360 CDX is a laboratory test that detects genetic mutations found in circulating cell-free DNA (cfDNA) to help doctors identify patients with non-small cell lung cancer who may benefit from specific FDA-approved treatments. The test checks for changes in more than 60 different genes. 

Interpretations

An interpretive report will be provided.

Performing Laboratory Name

Guardant Health, Inc.

Referral Laboratory Information

Address Telephone Website Link
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 7 days Digital next-generation DNA sequencing

CPT Codes

CPT Modifier
(if needed)		 Quantity Description Comments
 
0242U   1    

Ordering Applications

Ordering Application Description
Cerner Guardant 360 CDX