MSK-ACCESS Receives New York State Green Light for New Molecular Assay

Jun 22, 2019 | Memorial Sloan Kettering, Molecular Assay, Molecular Oncology

scientist working with multi well plate for cell culture in the lab / lab technician pipetting plate in the genetic laboratory

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-Josee 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 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,” said David Klimstra, MD, Chair of MSK’s Pathology Department.

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