MSK receives approval for new molecular assay from New York State Department of Health

Memorial Sloan Kettering Cancer Center (MSK) announced that the New York State Department of Health has issued an approval for a new molecular assay called Analysis of Circulating cfDNA to Evaluate Somatic Status (MSK-ACCESS). MSK-ACCESS was developed within the Marie-Josée and Henry R. Kravis Center for Molecular Oncology (CMO), and the test has been clinically validated and implemented by members of MSK's Molecular Diagnostics Service.

Bottom line: The MSK-ACCESS assay is a comprehensive liquid biopsy test that offers noninvasive cancer genomic profiling and disease monitoring. It involves the deep sequencing of 129 key cancer-associated genes selected from MSK's solid tumor genomic-profiling assay, MSK-IMPACT. MSK-ACCESS is designed to detect genetic alterations in cfDNA (cell-free DNA) specimens, such as blood and other body fluids.

What is cfDNA? CfDNA is released from cells throughout the body, including cancer cells, and is found in blood plasma as well as other body fluids, such as saliva and urine. In people with cancer, cfDNA may contain circulating DNA shed from dying cancer cells, which can be detected by highly sensitive sequencing methods. Using MSK-ACCESS, molecular diagnosticians can analyze cfDNA through a simple blood draw, providing a unique and noninvasive way to profile the genomic characteristics of the underlying tumor and guide treatment decisions.

The difference between MSK-IMPACT and MSK-ACCESS: The letters in MSK-IMPACT represent its full name of Integrated Mutation Profiling of Actionable Cancer Targets. MSK-IMPACT is a targeted tumor-sequencing test available to MSK patients. It can detect mutations and other critical changes in the genes of both rare and common cancers. MSK-ACCESS allows for deeper sequencing coverage and higher sensitivity to detect mutations.

Precision medicine at MSK: MSK has paved the way in the field of precision medicine, beginning with the landmark publication of the first basket trial in the New England Journal of Medicine in August 2015. (Basket trials are tumor-agnostic clinical trials that explore responses to drugs based on the specific mutations in tumors rather than where the cancer originated.) Data from that trial led to the the US Food and Drug Administration's first approval of a targeted therapy based on a basket trial in November 2017.

Throughout this journey from bench to bedside, the MSK team has continued to pioneer tumor-agnostic treatment approaches and next-generation sequencing (through MSK-IMPACT), publishing a seminal review of the rapidly evolving field of precision oncology in Cell in February 2017, and contributing to research that lead to the FDA's landmark approval of the drug larotrectinib (Vitrakvi®) for cancer caused by a genetic mutation called a TRK fusion in November 2018.

Expert commentary:

MSK-ACCESS could potentially be used for patients whose tumor tissue isn't available or is difficult to biopsy, or if MSK-IMPACT on a tumor biopsy fails to produce informative results because too few tumor cells were in the biopsy, which primarily happens in people with advanced metastatic cancer." said

Michael Berger, PhD, Associate Director of the Marie-Josée and Henry R. Kravis Center for Molecular Oncology

"The analysis of circulating tumor DNA will open the doors to new applications, like the detection of minimal residual disease or molecular resistance, and even the early detection of cancer," says Luis Diaz, MD, Head of the Division of Solid Tumor Oncology and Director of the Precision Interception and Prevention (PIP) program.

The MSK-ACCESS liquid biopsy test will complement our FDA-cleared MSK-IMPACT tumor-profiling test. This will further enhance the way we match patients at MSK to the targeted therapies most likely to benefit them."

Marc Ladanyi, MD, Chief of MSK's Molecular Diagnostics Service

The successful launch of MSK-ACCESS demonstrates how researchers engaged in technology development can work closely with the members of our clinical molecular diagnostics team to create and validate novel custom assays that serve the needs of our patients."

David Klimstra, MD, Chair of MSK's Pathology Department

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