> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Authorizes Cancer Tumor Profiling Test
- URL: https://www.fdaweb.com/fda-authorizes-cancer-tumor-profiling-test/
- Published: 2017-11-15T12:00:00.000Z
- Updated: 2026-09-14T23:01:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140133

FDA has authorized Memorial Sloan Kettering Cancer Center’s IMPACT (integrated mutation profiling of actionable cancer targets) tumor profiling test, an *in vitro* diagnostic assay that can identify a higher number of biomarkers than may be found in various cancers with any test previously reviewed by the agency. IMPACT was reviewed through the *de novo* premarket review pathway that is available for some low- to moderate-risk devices that are novel and for which there is no predicate device. An agency [news release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585347.htm?ref=fdaweb.com) says its ability to detect genetic mutations was evaluated for precision, accuracy, and limit of detection. Results indicated that the assay is highly accurate (greater than 99%) and capable of detecting a mutation at a frequency range of 2-5%.

The IMPACT test uses next generation sequencing (NGS) to rapidly identify the presence of mutations in 468 unique genes, as well as other molecular changes in the genomic makeup of a person’s tumor.

FDA says the authorization advances a policy framework that paves the way for efficient review and availability of other NGS-based cancer profiling tools.

Also, the agency says, the New York State Department of Health has been accredited as an FDA third-party reviewer of *in vitro* diagnostics, including tests similar to the IMPACT assay. In the future, it says, laboratories whose NGS-based tumor profiling tests have been approved by that state agency will not need to submit a separate 510(k) application to FDA. FDA says that other third-party reviewers also may become eligible to conduct such reviews and make clearance recommendations.

With its marketing authorization for the IMPACT test, FDA says, it is establishing a Class 2 regulatory pathway for the review of other NGS-based tumor profiling tests for use in patients diagnosed with cancer. The Class 2 designation allows such tests to be eligible to use FDA’s 510(k) clearance process, either by submitting an application directly to the agency or by going through an accredited third-party reviewer such as the New York State Health Department.