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: therascreen KRAS RGQ PCR Kit
PMA Applicant: QIAGEN GmbH
Address: QIAGEN Strasse 1, 40724 Hilden, Germany
Approval Date: May 28, 2021
Approval Letter: Approval Order
What is it?
The therascreen KRAS RGQ PCR Kit is a laboratory test that detects seven mutations found in the KRAS gene of non-small cell lung cancer and colorectal cancer to help doctors identify patients with these cancers who may benefit from specific FDA-approved treatments.
This approval expands the indications for use of the therascreen KRAS RGQ PCR Kit to include patients with non-small cell lung cancer who may benefit from treatment with LUMAKRAS (sotorasib).
How Does it work?
The doctor takes a small sample of tumor tissue from a patient with non-small cell lung cancer and sends it to a laboratory. In the laboratory, DNA is isolated from the patient’s tumor cells and mixed with chemical substances called reagents that find and test the DNA sequences of the tumor’s KRAS gene, looking for mutations. A medical professional reviews the results and sends a report to the patient’s doctor. The doctor uses this information to help manage the care of patients with non-small cell lung cancer.
When is it used?
The therascreen KRAS RGQ PCR Kit is used to test the tumors of patients with non-small cell lung cancer.
What will it accomplish?
Test results from the therascreen KRAS RGQ PCR Kit are used to help doctors decide if patients with non-small cell lung cancer are eligible for treatment with LUMAKRAS (sotorasib).
When should it not be used?
There are no known reasons not to use this test.