This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Agilent Resolution ctDx FIRST 
PMA Applicant:  Resolution Bioscience, Inc.
Address: 550 Kirkland Way, Suite 200, Kirkland, WA 98033 USA
Approval Date:  December 12, 2022 
Approval Letter:  Approval Order

What is it?

Agilent Resolution ctDx FIRST is a laboratory test that detects a specific mutation in the KRAS gene in circulating cell-free DNA. This test helps doctors identify patients with non-small cell lung cancer who may benefit from personalized treatment with KRAZATI (adagrasib). This laboratory test is a companion diagnostic for the treatment with KRAZATI.

How does it work?

A patient’s blood sample is sent to a lab for testing. The cfDNA is separated from the sample and mixed with chemical substances, called reagents, that find and test it for gene changes. A medical professional reviews the results and sends a report to the patient’s doctor. The doctor uses this information to help create a treatment plan for the patient’s non-small cell lung cancer.

When is it used?

Agilent Resolution ctDx FIRST is used to test the blood of patients with non-small cell lung cancer may be eligible for a specific therapy or personalized treatment for their cancer.

However, if the specific mutation in the KRAS gene is not found, then the patient’s eligibility for treatment of non-small cell lung cancer with KRAZATI (adagrasib) should be determined by testing their tumor tissue specimen with an FDA-approved tumor tissue test, unless a tumor biopsy cannot be done.

What will it accomplish?

Test results from the Agilent Resolution ctDx FIRST test are used to help doctors determine if a patient with non-small cell lung cancer may benefit from treatment with KRAZATI (adagrasib).

When should it not be used?

There are no known reasons not to use this test.

Additional information (including warnings, precautions, and adverse events):

• Summary of Safety and Effectiveness Data (SSED)
• Physician labeling
• PMA Database entry