Hackensack Meridian Health said Thursday that the Center for Discovery and Innovation (CDI) created a test to dramatically reduce the time it takes for diagnosing COVID-19.
This is a major advance that will benefit patients, create a more effective triage system in its hospitals and potentially better control the spread of disease. The diagnostic tool will reduce the current process of testing for COVID-19 from days to hours.
“Our mission at Hackensack Meridian Health is to transform health care and this new rapid test does precisely that,” said Robert Garrett, chief executive officer of Hackensack Meridian Health. “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.’’
The test permits the 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 CDI received preliminary Emergency Use Authorization from the Food and Drug Administration to start using the test Thursday. The New Jersey Department of Health has also approved the test.
“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,’’ said Chris Neuwirth, assistant commissioner of the New Jersey Department of Health.
“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,” Neuwirth said.
The CDI test combines elements of the U.S. Centers for Disease Control and Prevention (CDC) diagnostic, and a test developed in Germany and adopted by the World Health Organization (WHO). CDI experts began work on the test in mid-January, following the outbreak of the virus first identified in China in December 2019.
“We believe our test could make the difference in stemming outbreaks,” said David Perlin, the chief scientific officer and senior vice president of the CDI. “It’s fast and it’s accurate, and crucial hours could mean the difference in stopping the spread of this virus.”
Last week, the center received live virus and viral RNA, a crucial step toward bringing the test to use in clinical settings, said Perlin, a global infectious diseases expert who helped develop diagnostics for SARS and other infectious diseases. The CDI validated the results and completed FDA requirements to administer the test.
Initially, the network will be able to test 24 patients every eight hours. The goal is to capitalize on the technology and find ways to expand its use in the region as the need for testing continues to grow: More than 127,000 cases are confirmed globally and New Jersey is reporting 23 presumptive positives, according to health officials.
Officials stress that the network will continue to follow strict protocols on which patients will be tested—patients cannot simply request the test if they believe they have been exposed to the virus or are experiencing respiratory symptoms.
“Having our own test, which allows us to respond in real-time, is the crucial tool we need at the point of care when we need it most,” said Dr. Daniel Varga, chief physician executive for Hackensack Meridian Health. Varga was chief clinical officer for Texas Health Resources, which oversaw a massive response in and around Dallas to the Ebola virus outbreak in 2014.