The Northwell Health Cancer Institute and its Center for Genomic Medicine announced the opening of Long Island’s first clinical Molecular Diagnostics Laboratory (MDL), a $3.2 million 2,800 square foot state-of-the-art facility with cutting edge technology of next-generation sequencing (NGS) that provides point-of-care tumor and patient genomic profiling to inform precision cancer therapy. The MDL will provide improved accuracy of diagnosis and prognosis for cancer patients as well as a lower costs to patients and the health system.
All tests performed by the MDL are CLIA (Clinical Laboratory Improvement Amendments of 1988)-certified by the New York State Department of Health, ensuring that they are compliant with all regulatory and quality standards. The MDL is integrated with Northwell Health Laboratories, located at 450 Lakeville Road in Lake Success, which leverages existing operations and taps into specialized clinical staff. It is also closely aligned with Northwell’s Department of Pathology and Laboratory Medicine. The MDL is equipped with eight Genexus Integrated Sequencers that automate next-generation sequencing to efficiently analyze solid tumor and blood samples for specific genetic mutations, known as biomarkers. This technology will provide a dramatically faster turnaround time for results and deliver targeted treatments for patients.
With a commitment to advancing innovation and the best in cancer care, the new lab’s highly specialized team is comprised of physicians, scientists, cancer genetics researchers, molecular pathologists, experts in bioinformatics and clinical technologists. It will also collaborate with an existing molecular tumor board.
“We are proud to unveil our Molecular Diagnostic Laboratory designed to deliver point-of-care genomic testing to improve the lives of patients with cancer, which is the standard of care in oncology,” said Jeff Boyd, PhD, vice president and chief scientific officer and director of the Northwell Health Cancer Institute’s Center for Genomic Medicine. “This clinical achievement further demonstrates our commitment to advancing cancer care and access to precision medicine throughout our health system and the communities we serve.”
Dr. Boyd explained that the lab will use high-end DNA sequencing to extract and define the genomic details of each individual tumor because no two tumors are the same. “It’s critical to know the genetic architecture of each tumor so we can know how best to treat the type of cancer,” said Dr. Boyd.
The Molecular Diagnostics Laboratory will offer a menu of tests to providers in a phased approach. Initially, the lab will provide four single-gene tests: EGFR for non-small cell lung cancer; BRAF for melanoma; KRAS for colorectal, pancreatic and lung cancers; and BRAF/NRAS for melanoma.
In the coming months the MDL will offer a 161-gene NGS panel for solid malignancies (Themo Fisher Oncomine Comprehensive Assay v3), a 45-gene NGS panel for hematologic malignancies (Thermo Fisher Oncomine Myeloid Assay), and MSI-H, a genetic test to inform whether tumors should respond to immunotherapy.
Northwell Health Cancer Institute treats more New York residents for cancer than any other provider in the state*. The health system expects that approximately 40 percent of its 19,000 new cancer patients treated each year will meet National Comprehensive Cancer Network’s guidelines, making them eligible for one or more tests.
Richard Barakat, MD, physician-in-chief and executive director of the Northwell Health Cancer Institute, noted the new MDL is not only providing the most advanced genomic cancer testing available, but also is enhancing care and access for patients in the New York metropolitan area.
“Providing in-house biomarker testing for all cancer patients in the health system means faster lab results, which can lead to treatments starting sooner. Now, we can provide patients with test results in 48 hours or less compared to three weeks with an outside commercial lab,” said Dr. Barakat. “Our oncology teams offer an extraordinary continuum of care for our patients with cancer and their loved ones – and the most advanced genomic diagnostic testing.”
Previously, the Northwell Health Cancer Institute was outsourcing molecular diagnostic testing. Bringing the sophisticated testing onsite, experts can offer same day testing with faster results, maintain quality control, answer clinicians’ questions quickly, and test results are integrated in a patient’s electronic medical record making them easily accessible to oncologists and their care teams.
The Center for Genomic Medicine brings a comprehensive, multidisciplinary state-of-the-art program to Northwell Health to support cancer clinical care, clinical trials, translational research and continuing medical education.
*According to the Statewide Planning and Research Cooperative System inpatient and ambulatory surgery data.
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