Hackensack Meridian Health has gotten U.S. Food & Drug Administration approval to begin using the COVID-19 test it developed in its Center for Discovery and Innovation.
HMH officials said the test will dramatically reduce the time it takes for diagnosing COVID-19, calling it a major advance that will benefit patients, create a more effective triage system in hospitals and potentially better control the spread of disease.
HMH began using the test at Hackensack University Medical Center on Thursday morning.
The new diagnostic tool will help the health network to quarantine and treat patients suspected of having COVID-19 more rapidly or, in the case of a negative result, spare the patient unnecessary time in the hospital.
The state Department of Health also has approved the test.
Dr. David Perlin, the chief scientific officer and senior vice president of the CDI, said he feels the test will have a huge impact.
“We believe our test could make the difference in stemming outbreaks,” Perlin said. “It’s fast and it’s accurate, and crucial hours could mean the difference in stopping the spread of this virus.”
(To learn more about the test from Perlin, click here.)
Chris Neuwirth, assistant commissioner of the New Jersey Department of Health, was thrilled by the news.
“The Department of Health commends Hackensack Meridian Health’s effort in bringing online their laboratory to test for SARS-COV-2 and adding more testing capacity in New Jersey,’’ he said in a release. “As more hospital and commercial laboratories begin testing, New Jersey residents will have greater access to SARS-COV-2 diagnostic testing and public health officials will have a greater ability to monitor, track and respond to new cases.”
The CDI test combines elements of the U.S. Centers for Disease Control and Prevention diagnostic with a test developed in Germany and adopted by the World Health Organization. CDI experts began work on the test in mid-January, following the outbreak of the virus first identified in China in December 2019.
HMH CEO Bob Garrett said the development of the test fits the mission of CDI.
“Our mission at Hackensack Meridian Health is to transform health care, and this new rapid test does precisely that,” he said. “We are all proud to provide this game-changing diagnostic tool, which will ultimately benefit communities far beyond New Jersey. I applaud the efforts of the CDI in achieving this breakthrough.’’
Last week, Perlin told ROI-NJ that he would help other health systems use the test.
“It is 100% transferable,” he said. “We build the test so that others could use it, that we can roll it out further in our system and to others.
“We’re here to try to improve clinical outcomes. And the only way to do that is to diagnose early and accurately. That’s the test that we built and, if others need to use it, we’ll be happy to provide them with all or everything that’s required to run this test. And, then, if they need training, they can come here — we’ll train them.”
