The Food and Drug Administration (FDA) on 12 December 2022 announced the approval of Agilent’s Resolution CTDX FIRST, a new in vitro diagnostic (IVD) medical device for use in the detecting 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.
According to the FDA announcement, the Resolution CTDX FIRST, manufactured by Resolution Bioscience Inc., is a next-generation sequencing platform that provides a high-throughput and cost-effective solution in finding and testing blood samples for gene changes. The device uses a unique combination of cutting-edge technology and advanced software algorithms to analyze genetic information in a patient’s sample, allowing for individualized treatment plans for patients diagnosed with non-small cell lung cancer.
Benefits of Early Detection
The FDA’s approval of the Resolution CTDX FIRST marks a major milestone for Agilent and for the field of cancer treatment. The device provides healthcare providers with a new tool for early detection of specific gene changes, which is crucial for improving patient outcomes and reducing the mortality rate from non-small cell lung cancer.
FDA has posted Summary of Safety an Effectiveness Data (SSED) here.
Conclusion
In conclusion, the approval of the Resolution CTDX FIRST by the FDA is a significant development in the field of cancer treatment. The device provides healthcare providers with a highly-sensitive and accurate tool for detecting key elements in determining treatment of non-small cell lung cancer at an early stage, which is crucial for improving patient outcomes and reducing the mortality rate from cancer.
The FDA’s approval of the Resolution CTDX FIRST highlights the agency’s commitment to advancing the field of medical technology and ensuring that patients have access to the best possible diagnostic and treatment options.
Read the Announcement
Click here for the FDA announcement
Agilent Resolution ctDx FIRST test kit