Therascreen KRAS RGQ PCR Kit new medical device

Therascreen KRAS RGQ PCR Kit FDA approved Laboratory Device

Therascreen KRAS RGQ PCR Kit is one of the Medical Devices Cleared or Approved by the FDA in 2021 which is now will available in the market. This device is another great initiative in the field of medicine. We shall discuss more it in this article in detail. What is the purpose of this medical device and when and when it not should be used and so many other things related to this medical equipment?  If you’re a medical professional or student then you must be aware of new changes and discovered devices and we shall try to post such types of articles also. Complete detail is appended below.

Book Name therascreen KRAS RGQ PCR Kit 
PMA Applicant PMA Applicant
Category Medical Equipment & Devices
Approved year 28 May 2021
Used in  Laboratory Test

 

Introduction of Device:

The therascreen KRAS RGQ PCR Kit is a laboratory test that detects seven mutations o found in the KRAS gene for non-small cell lung cancer and colorectal cancer help clinicians identify patients with these cancers who may benefit from specific treatments. FDA approved.

Working Procedure of this device:

It is said that the doctor takes a small sample of tumor tissue from a patient with non-small cell lung cancer and sends it to a laboratory. Further, In the laboratory, DNA is isolated from tumor cells from patients and mixed with chemicals called reagents that find and test the DNA sequences of the KRAS gene in tumors for mutations. The report is sent to the doctor of the patient after review by a medical professional. The doctor uses this information in order to help manage the care of patients with non-small cell lung cancer.

Right time of usage:

This device should be used used to test the tumors of patients with non-small cell lung cancer. This device is developed for this purpose.

When should it not use:

Currently, there is no reason is described when it should not be used. As we read above that this device is used in the laboratory for the purpose of the test to find the KRAS gene for non-small cell lung cancer and colorectal cancer.

Therascreen KRAS RGQ PCR Kit laboratory device
Credit: FDa.gov

 

Benefits:

Test results from the therascreen KRAS RGQ PCR Kit are used to help clinicians decide whether patients with non-small cell lung cancer are eligible for treatment with LUMAKRAS (sotorasib). So it is a great achievement in medical after approved this medical device.

Effectiveness Results:

The effectiveness of the therascreen KRAS RGQ PCR Kit to identify KRAS G12C mutation positive patients who may benefit from LUMAKRAS™ (sotorasib) is supported by the efficacy results from the primary analysis of Study 20170543. The efficacy results show that LUMAKRAS™ (sotorasib) monotherapy provides a clinically meaningful benefit to NSCLC patients with KRAS G12C mutations. The ORR for NSCLC subjects as assessed by BICR per RECIST 1.1 for subjects with NSCLC was 36% (46 of 124 subjects; 95% CI: 28-45%) with 2 subjects (1.6%) achieved complete response and 44 subjects (35.8%) achieved a partial response. The lower limit of the 95% CI of 28% showed statistically significant sotorasib efficacy relative to the benchmark ORR of 23% for NSCLC based on the trial REVEL trial (ramucirumab plus docetaxel in second-line setting) (Table 20).

Summary of effectiveness results in the primary efficacy population by BICR

 

Here you can read more about this device download file here

I shall try to post further from time to time information regarding this device. So every medical professional and student can get in touch with new devices.

 

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