The first facility on Long Island, NY to offer next-generation sequencing with point-of-care genomic testing opened this May, and brought access to state of the art medical technology to patients in 6 different counties in the region.
Before Northwell Health Cancer Institute’s $3.2 million 2,800 square foot clinical molecular diagnostics laboratory (MDL) opened this May, in Lake Success, New York, no facility on Long Island offered next-generation sequencing (NGS) with point-of-care genomic testing. Now this lab’s 8 genetic sequencers automate NGS to efficiently analyze solid tumor and blood samples for biomarkers and inform precision therapy for patients with cancer. The former lack of such a facility left patients of the 6 counties that make up Northwell Health’s catchment area—Queens, Nassau, Suffolk, Manhattan, Westchester, and Staten Island—without access to medical technology that has become both state of the art and the standard of care in oncology, according to Jeff Boyd, PhD, vice president and chief scientific officer and director of Northwell Health Cancer Institute’s Center for Genomic Medicine.
“The quality of the care that you receive, when you have cancer or indeed any disease, shouldn’t depend on your ZIP code or your socioeconomic status,” Dr. Boyd said in a recent conversation with the Association of Cancer Care Centers (ACCC). He noted the diversity of Northwell Health’s patients, about half of whom are from ethnic and racial communities that have been marginalized. “I think it’s part of our mission and our vision at Northwell to serve this population, which typically is underserved, and it’s altogether appropriate and proper that we bring this state-of-the-art care to all of our patients, not simply those who can afford it or who live closer to a major academic medical center.”
Previously, Northwell Health Cancer Institute outsourced molecular diagnostic testing, a workable arrangement adopted by many cancer programs, but one that injects distance, time, and a sort of faceless anonymity into the process of obtaining a patient’s molecular pathology report. An example Dr. Boyd cited was a physician calling an 800-number in Houston “and speaking with a genetic counselor at that corporate entity who doesn’t know the patient and doesn’t know the physician.”
The timeline for a result procured in that way might have been weeks. Now it’s a matter of hours or days before receiving the result and entering it into the electronic health record for an oncologist to access. “We can provide the care, or the information which leads to the care, with a much faster turnaround time because we’re reducing a lot of steps in the process by doing this as close to the patient as possible,” Dr. Boyd said.
The time saved can have a big impact. “It does translate into more rapid care for patients, and hours and days make a big difference in many cases, depending on the context,” Dr. Boyd said. “They can certainly translate to big differences in outcome.”
The finer attention to detail that the diagnostics lab’s operations enable give it an edge compared to some commercial labs. The sheer volume of data handled by some of those facilities means molecular pathology reports are often curated by artificial intelligence or machine learning algorithms, which are occasionally prone to errors or may be overseen by a lab employee responsible for generating hundreds of reports per day who is unable to thoroughly review them. “I think the quality of the data we [Northwell’s MDL] generate is arguably superior, because we actually have human beings, more than 1 in fact, looking at every result we send out,” Dr. Boyd said. If a busy physician looks only at the front page of such a report, which contains the essence of the answer, “they’re not digging into the curation to do quality control. That’s our job,” he said, emphasizing the critical nature of the work: “Every patient result is important; when you’re informing patient care—this is a sacred trust, and you can’t afford to use shortcuts to accuracy in terms of the veracity of the data in the reports that we generate.”
Tests performed by the MDL have been designed to comply with all regulatory and quality standards, including Clinical Laboratory Improvement Amendments (CLIA) as well as New York’s Clinical Laboratory Evaluation Program, the state’s slightly more stringent equivalent to the federal standards. The extensive package of information the state requires to approve each test includes a set of standard operating procedures and data supporting the test’s analytical validity. The MDL’s phased approach means that its initial 4 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—will ultimately be followed by multigene NGS panels for solid malignancies and hematologic malignancies as well as a genetic test to inform whether tumors are likely to respond to immunotherapy.
An added benefit of having the doctoral-level, board-certified expertise that undergirds the MDL in house is that the lab director can interact directly with a patient’s care team to answer any questions they may have, specifically about what Dr. Boyd refers to as the tumor-gene-drug triad, essentially the result the MDL produces to inform precision therapy.
It is one component of a larger process enabled by the new facility to support better outcomes through more timely care that puts patients first. “We’re not beholden to stakeholders, to venture capitalists, to the shareholders; we’re beholden only to patients,” Dr. Boyd concluded.
Jeff Boyd, PhD, vice president and chiefscientific officer and director of the Northwell Health Cancer Institute’sCenter for Genomic Medicine, cuts the ribbon on the new molecular diagnosticslab, joined by the leadership of Northwell’s Cancer Institute and Department ofPathology and Laboratory Medicine.
Photo credit: LeeWeissman/Northwell Health
