T2 Biosystems has developed the T2SARS-CoV-2 Panel in response to the COVID-19 pandemic. The Panel is commercially available and was awarded Emergency Use Authorization by the FDA on August 31, 2020. The Panel was validated in accordance with the Emergency Use Authorization requirements from the FDA. The Panel is being distributed in accordance with the FDA guidance on Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised).
“We are proud to announce the U.S. launch of our molecular diagnostic test, the T2SARS-CoV-2 Panel, which has demonstrated excellent clinical performance. Adding this test to our existing sepsis-related portfolio illustrates our commitment to transformative diagnostics that improve the lives of patients,” said John Sperzel, President and Chief Executive Officer of T2 Biosystems. “Given the susceptibility of critically-ill COVID-19 patients to develop bacterial or fungal co-infections and secondary infections that can lead to sepsis, we believe our platform can be used to identify acute COVID-19 infections, and optimize outcomes for patients under intensive care.” – John Sperzel, CEO and President, T2 Biosystems
Background on COVID-19
There is a lot of uncertainty surrounding COVID-19, but what we do know is that COVID-19 can lead to sepsis1. The World Health Organization declared COVID-19 a global health emergency, calling it an “unprecedented outbreak.” Millions of people have been diagnosed, and many remain in critical condition suffering from acute respiratory failure, septic shock, and/or multiple organ dysfunction and failure. These patients are treated in the ICU, where they are exposed to countless risk factors that can lead to secondary infections or co-infections, including exposure to numerous antimicrobial therapies, which are often unnecessary. T2 Biosystems’ diagnostic panels enable clinicians to identify sepsis-causing pathogens in 3 to 5 hours and provide targeted therapy faster, thus reducing unnecessary exposure to the virus and optimizing outcomes for COVID-19 patients with secondary bacterial or fungal infections, or co-infections.
There are a variety of human coronaviruses, some of which can cause respiratory infections ranging from the common cold to Middle East Respiratory Syndrome (MERS) or Severe Acute Respiratory Syndrome (SARS). The most recent coronavirus (SARS-CoV-2) that was discovered in Wuhan, China, in December 2019, is responsible for COVID-19.
The symptoms of COVID-19 can vary greatly, but many of those infected will experience fever, tiredness, and dry coughs. Other symptoms include aches and pains, nasal congestion, runny nose, sore throat, and diarrhea, while some people do not develop any symptoms at all. Around 80% of people recover from the disease without requiring special treatment, but 1 out of every 6 people that are infected with COVID-19, develop difficulty in breathing and become very ill.2
Multiple SARS-CoV-2 variants have been detected around the globe, including in the United Kingdom (B.1.1.1), South Africa (B.1.351), and Brazil (P.1). The CDC has highlighted the ability to evade detection by specific viral diagnostic tests as a potential consequence of emerging variants. To confirm that the T2SARS-CoV-2 Panel should detect these newly identified variants of the SARS-CoV-2 virus, an in silico analysis was performed using genome sequences available from the NCBI and GISAID databases. The analysis showed that the Panel can detect 99.99% of all currently identified variants of the SARS-CoV-2 virus.
How COVID-19 is Transmitted
The virus is most likely to spread when people are in close contact with one another. COVID-19 spreads when its causative virus is passed from person to person, usually through respiratory droplets that occur when someone that is infected coughs or sneezes. When a person is nearby, when this happens, the droplets may be inhaled into the lungs.3 Although a person may contract the virus from touching a surface or object that has the virus on it and then touching their face, it is not thought to be the primary method of transmission.
How to Protect Yourself
The most effective way to prevent yourself from getting the virus is to avoid being exposed to it, but there are also other methods that the CDC recommends to reduce your risk.4
Wash your hands with soap and water for at least 20 seconds, especially after going out in public. If you need to use hand sanitizer instead of soap, make sure that it contains at least 60% alcohol and cover all surfaces of your hands until they are dry.
Avoid close contact with anyone who is sick and stay at home as much as you can. If you are out in public, keep your distance from people.
Cover your nose and mouth with a face covering when you are around others. It is possible to spread COVID-19 even if you don’t feel sick; the mask is to protect other people in case you are infected, in addition to protecting yourself. Note: a face covering is not a substitute for social distancing.
Cover coughs and sneezes with a tissue or the inside of your elbow, be sure to throw away any used tissues and wash your hands for at least 20 seconds with soap and water.
Keep Surfaces Clean
Clean and disinfect any frequently touched surfaces every day (tables, doorknobs, light switches, countertops, desks, and phones). For more information on cleaning and disinfecting for households, read the CDC’s Cleaning and Disinfection for Households Guide.
Please contact us for questions related to COVID-19 testing.
5. T2SARS-CoV-2 clinical data on file