Guardant 360 CDX

Test Code: GCDXSO

Overview
Ordering
Specimen
Performing
Clinical/Interpretive
Contacts
Coding

Useful For

A 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 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 dyas from the time of collection.

Specimen Stability Information

Specimen Type	Temperature	Time
Whole Blood	Ambient	7 days

Rejection Criteria

Refrigerated specimen

Frozen specimen

Performing Laboratory Information

Performing Location	Day(s) Test Performed	Analytical Time	Methodology/Instrumentation
Guardant Health, Inc.	Sunday through Saturday	7 days	Digital next-generation DNA sequencing

Reference Lab

Guardant Health, Inc.

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.

Interpretation

An interpretive report will be provided.

Ordering Applications

Ordering Application	Description
Cerner	Guardant 360 CDX

If the ordering application you are looking for is not listed, contact your local laboratory for assistance.