Rapid-Response COVID-19 Test Gets Emergency Approval

The COVID-19 virus, seen under a microscope.

HACKENSACK—Hackensack Meridian Health, New Jersey’s largest and most comprehensive health network, is pleased to announce that the Center for Discovery and Innovation (CDI) has 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 our hospitals and potentially better control the spread of disease, HMH said in a press release at press time, the afternoon of March 12.

This comes as the United States faces criticism over its Centers for Disease Control response, being led by Vice President Mike Pence. U.S. Rep. Bill Pascrell (D-NJ9), who represents portions of the Northern Valley in Congress, called on the CDC to increase its transparency as the epidemic grows. 

Robert C. Garrett, FACHE, chief executive officer of Hackensack Meridian Health, said “We are all proud to provide this game-changing diagnostic tool which will ultimately benefit communities far beyond New Jersey”

The new diagnostic tool will reduce the current process of testing for COVID-19 from days to hours. 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 Center for Discovery and Innovation received preliminary Emergency Use Authorization from the Food and Drug Administration to start using the test today. Additionally, the state 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.”

The new diagnostic tool will reduce the current process of testing for COVID-19 from days to hours. 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 Center for Discovery and Innovation received preliminary Emergency Use Authorization from the Food and Drug Administration to start using the test today. Additionally, the state 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.”

To learn more about the test from Dr. Perlin, visit youtube.com/watch?v=8mcaF6rGSTU.

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

Last week, the center received live virus and viral RNA, a crucial step toward bringing the test to use in clinical settings, said Dr. 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. Our goal is to capitalize on the technology and find ways to expand its use in the region.

The need for testing continues to grow: more than 127,000 cases are confirmed globally; 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. Patients should first consult with their primary care physician to determine if they are a candidate for testing.