Hackensack Meridian Health’s COVID-19 Test Licensed for Widespread Deployment

New test licensed to Massachusetts-based T2 Biosystems, opening up access

Hackensack Meridian Health announced that a rapid test for COVID-19 created by its labs at the Center for Discovery and Innovation (CDI) has been licensed to T2 Biosystems, a Massachusetts-based leader of in-vitro diagnostics.

The wider deployment of the COVID-19 test, already in use in the Hackensack Meridian Health network, will meet a crucial need amid the continuing spread of the novel coronavirus.

“Our scientists at the CDI have given our health network a crucial tool to treat New Jersey patients in real-time,” said Robert C. Garrett, FACHE, chief executive officer of Hackensack Meridian Health. “Now their innovation will help others at this time of urgent need.”

“A coronavirus test fits within our company’s mission: to save lives and improve health care by allowing clinicians to treat patients faster and more effectively,” said John Sperzel, president and chief executive officer of T2 Biosystems. “With this partnership, our company and the team at Hackensack Meridian Health are leveraging our strengths to benefit patients suspected of primary or secondary infections associated with COVID-19.”

Under this agreement, T2 Biosystems is authorized to adapt the CDI-developed COVID-19 test to the T2 Biosystems platform, and market and distribute the test in places of need amid the expanding pandemic. The test will be capable of running on the T2Dx® Instrument, the same instrument which runs the FDA-cleared T2Bacteria® and T2Candida® Panels. The T2Bacteria and T2Candida Panels enable the rapid identification of sepsis-causing bacterial and fungal pathogens, providing results in three to five hours directly from whole blood, enabling clinicians to target therapy for patients with secondary bacterial or fungal infections associated with primary COVID-19 infections.

The CDI’s diagnostic tool, in use under the U.S. Food and Drug Administration’s (FDA) Emergency Use Authorization guidance since March 12, has significantly shortened the timeline for COVID-19 testing in the Hackensack Meridian Health network. The test has allowed health professionals in the New Jersey locations to quarantine and treat patients suspected of having COVID-19 more rapidly, allocate critical resources more effectively and, in the case of a negative result, spare the patient unnecessary time in the hospital.

“The test, a highly sensitive and accurate novel assay, provides definitive results quickly. It combines in a new format the best elements found in the CDC and WHO diagnostics,” said David S. Perlin, Ph.D., the chief scientific officer and senior vice president of the CDI. “The CDI scientists who worked tirelessly on this rapid test should be commended for moving fast to use their expertise to save lives.”

CDI experts, including Yanan “Nancy” Zhao, M.D., Ph.D., began work on the test in mid-January, following the outbreak of the virus first identified in China in December 2019.

Two weeks ago, the center received live virus and viral RNA, a crucial step toward bringing the test to use in clinical settings. The CDI validated the results in days and completed FDA requirements to administer the test. The Hackensack Meridian Health network has been able to test about 90 patients per day.

The pandemic has accelerated the need for testing: the World Health Organization has confirmed about 335,000 cases globally and the most recent reports indicate a death toll of approximately 14,500 people. In the United States, more than 33,400 cases have been reported across all 50 states, with more than 400 deaths, according to the latest Centers for Disease Control and Prevention (CDC) figures available this week.

Increased testing is needed to slow the spread of the virus from overwhelming the nation’s health care systems, according to health experts.

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