New test licensed to Massachusetts-based testing company, opening up access

NUTLEY, N.J., March 24, 2020 /PRNewswire/ -- Hackensack Meridian Health, New Jersey's largest and most comprehensive health network, is pleased to announce 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. 

Hackensack Meridian Health (PRNewsfoto/Hackensack Meridian Health)

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. 

About the Center for Discovery and Innovation

The Center for Discovery and Innovation, a newly established member of Hackensack Meridian Health, seeks to translate current innovations in science to improve clinical outcomes for patients with cancer, infectious diseases and other life-threatening and disabling conditions.  The CDI, housed in a fully renovated state-of-the-art facility, offers world-class researchers a support infrastructure and culture of discovery that promotes science innovation and rapid translation to the clinic. 

ABOUT HACKENSACK MERIDIAN HEALTH

Hackensack Meridian Health is a leading not-for-profit health care organization that is the largest, most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care. 

Hackensack Meridian Health comprises 17 hospitals from Bergen to Ocean counties, which includes three academic medical centers – Hackensack University Medical Center in Hackensack, Jersey Shore University Medical Center in Neptune, JFK Medical Center in Edison; two children's hospitals - Joseph M. Sanzari Children's Hospital in Hackensack, K. Hovnanian Children's Hospital in Neptune; nine community hospitals – Bayshore Medical Center in Holmdel, Mountainside Medical Center in Montclair, Ocean Medical Center in Brick, Palisades Medical Center in North Bergen, Pascack Valley Medical Center in Westwood, Raritan Bay Medical Center in Old Bridge, Raritan Bay Medical Center in Perth Amboy, Riverview Medical Center in Red Bank, and Southern Ocean Medical Center in Manahawkin; a behavioral health hospital – Carrier Clinic in Belle Mead; and two rehabilitation hospitals - JFK Johnson Rehabilitation Institute in Edison and Shore Rehabilitation Institute in Brick. 

Additionally, the network has more than 500 patient care locations throughout the state which include ambulatory care centers, surgery centers, home health services, long-term care and assisted living communities, ambulance services, lifesaving air medical transportation, fitness and wellness centers, rehabilitation centers, urgent care centers and physician practice locations.  Hackensack Meridian Health has more than 34,100 team members, and 6,500 physicians and is a distinguished leader in health care philanthropy, committed to the health and well-being of the communities it serves. 

The network's notable distinctions include having four hospitals among the top 10 in New Jersey by U.S. News and World Report.  Other honors include consistently achieving Magnet® recognition for nursing excellence from the American Nurses Credentialing Center and being named to Becker's Healthcare's "150 Top Places to Work in Healthcare/2019" list. 

The Hackensack Meridian School of Medicine at Seton Hall University, the first private medical school in New Jersey in more than 50 years, welcomed its first class of students in 2018 to its On3 campus in Nutley and Clifton.  Additionally, the network partnered with Memorial Sloan Kettering Cancer Center to find more cures for cancer faster while ensuring that patients have access to the highest quality, most individualized cancer care when and where they need it. 

Hackensack Meridian Health is a member of AllSpire Health Partners, an interstate consortium of leading health systems, to focus on the sharing of best practices in clinical care and achieving efficiencies. 

For additional information, please visit www.HackensackMeridianHealth.org. 

About T2 Biosystems

T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before.  T2 Biosystems' products include the T2Dx® Instrument, T2Candida® Panel, the T2Bacteria® Panel, and the T2Resistance™ Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology.  T2 Biosystems has an active pipeline of future products, including products for the detection of additional species and antibiotic resistance markers of sepsis pathogens, and tests for Lyme disease. 

(PRNewsfoto/Hackensack Meridian Health)

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SOURCE Hackensack Meridian Health