Memorial Sloan Kettering Cancer Center has developed the first tumor-profiling laboratory developed test (LDT) approved by the FDA. It's called MSK-IMPACT. Below are some details about the test from a recent article (see: FDA Authorizes MSK-IMPACT Test for Analyzing Patient Tumor):
The FDA’s authorization of MSK-IMPACT sets a precedent for future authorization of tests developed by both academic and commercial labs....The test was developed by Memorial Sloan Kettering’s Department of Pathology to look for genetic mutations and other alterations in patients’ tumors.....MSK-IMPACT, which stands for integrated mutation profiling of actionable cancer targets, has been used to analyze the tumors of people with advanced cancer being treated at MSK since January 2014.....When the test was first developed, it looked for alterations in 341 cancer-associated genes. Today, it looks for alterations in 468 genes. These alterations may be seen in both common and rare cancers.... It is now the first tumor-profiling laboratory-developed test to receive authorization through the FDA....To date, more than 20,000 MSK patients with advanced cancers have had their tumors sequenced. The resulting data have helped guide therapy while also providing a wealth of new information that is driving new investigations in the laboratory.....According to a study published earlier this year...which looked at the first 10,336 patients to have their tumors sequenced with MSK-IMPACT, nearly 37% had at least one actionable mutation. This means that drugs targeting these mutations were available. Based on those testing results, the paper reported, 11% of patients — about 1,000 people — were able to participate in clinical trials of treatments that directly targeted the genetic alterations in their tumors....One of these abnormalities, known as instability (MSI), occurs due to a defect in a process called DNA mismatch repair....Earlier this year, the FDA approved the immunotherapy drug pembrolizumab...for the treatment of tumors with MSI, regardless of where the tumors appear in the body.
To my mind, tumor profiling tests are extremely valuable in that they show the best way to seek out the genetic weakness of tumors. MSK-IMPACT fits the bill in this regard, revealing alternations in 468 cancer-associated genes. Changes in any of these genes in the tumor enable the treating oncologist to choose the optimal drug(s) for treatment of the lesion, taking advantage of its intrinsic genetic weaknesses. With increasing frequency, the approach will be immunotherapy agents, sometimes in combination. The timing of the use of such drugs is now becoming more important (see: Timing and Sequence Critical for Immunotherapy Combination). You may have a different opinion of LDTs (see: To Regulate or Not? The Lab Developed Test Saga Continues), but I am confident that a tumor-profiling test like MSK-IMPACT developed at a prestigious cancer hospital like MSK would be designed to assist their oncologists in optimally treating their patents.