T2 Biosystems, Inc. · OTC:TTOO
T2 Biosystems — Technical Presentation (May 2020)
21 slides from T2 Biosystems's technical presentation, May 20, 2020
Slide 1: COVID-19 and the Impact of Secondary and Co-Infections
COVID-19 and the Impact of Secondary and Co-Infections Sandy J. Estrada, Pharm.D., BCPS Vice President, Medical Affairs, T2 Biosystems
Slide 2: Objectives
Objectives • Review COVID-19 background as it relates to secondary and co-infections • Understand the current limitations of traditional methods in diagnosing secondary and co-infections • Identify appropriate COVID-19 patients at risk for secondary or co-infections to be tested with T2 Biosystems’
Slide 3: COVID-19 Overview
COVID-19 Overview • SARS-CoV2 is a novel coronavirus that was first reported in China in December 2019 • Individuals of all ages are at risk for infection and severe disease with the highest probability of fatality in people aged >65 • At present no agent is recommended for pre or post exposure prop
Slide 4: COVID-19 Statistics Worldwide
COVID-19 Statistics Worldwide As of May 13, 2020: • Total cases: > 4 million • ≈80,000 new cases/day • Total deaths: >280,000 • 201 countries/territories WHO Coronavirus Situation Report https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200513-covid-19-sitrep-114.pdf?sfvrsn=17
Slide 5: COVID-19 Diagnosis
COVID-19 Diagnosis • CDC has established a priority system for diagnostic testing for SARS-CoV-2 infection based on availability of testing1 • More than 70 diagnostic tests for SARS-CoV-2 infection have received Emergency Use Authorization (EUA) by the FDA - Most initial diagnostic tests have relied
Slide 6: COVID-19 Treatment Goals
COVID-19 Treatment Goals Recognize and prioritize patients with severe COVID-19 Implement strategies for infection prevention and control Provide early supportive care and monitoring Prevent/Treat COVID-19 complications 6
Slide 7: COVID-19 Diagnostic Challenges
COVID-19 Diagnostic Challenges • Risks of False Negatives with COVID-19 testing - Critically Ill Patients • Lack of access to investigational therapy • Inappropriate isolation or use of PPE causing risk to health care providers - Mild to Moderately Ill Patients • Exposure in the workplace • Lack of
Slide 8: Secondary and Co-Infections
Secondary and Co-Infections • Secondary infections with bacterial, viral, and other pathogens are well-described in influenza, SARS, MERS and other respiratory viral illnesses • Data regarding secondary and co-infections in COVID-19 are still emerging • Secondary infection: Also known as superinfect
Slide 9: Risk Factors for Secondary and Co-Infections
Risk Factors for Secondary and Co-Infections • Hospitalized patients, especially critically ill and mechanically ventilated are at risk for infections, independent of SARS-CoV-2 • Severe COVID-19 is associated with immune dysregulation creating opportunity for bacterial or fungal proliferation • Cyt
Slide 10: Diagnostic Challenges of Secondary and Co-Infections
Diagnostic Challenges of Secondary and Co-Infections • During 1918 and subsequent influenza pandemics, bacterial superinfections were common causes of mortality and morbidity1 • Studies have shown that up to 65% of laboratory-confirmed cases of influenza infection are complicated by bacterial co/sup
Slide 11: Data to Date: Secondary and Co-Infections in COVID-19
Data to Date: Secondary and Co-Infections in COVID-19 Preliminary studies suggest secondary infections are common, especially in severe cases 11
Slide 12: Case Study: Secondary Candidemia in a COVID-19 Positive Patient
Case Study: Secondary Candidemia in a COVID-19 Positive Patient • Case Summary - 67 year old patient admitted with cough and fever after recent travel to New York - Day 1: SARS-CoV-2 PCR was positive • Treated with 5 day of empiric hydroxycholorquine and azithromycin • An additional 5 days of hydrox
Slide 13: COVID-19 Impact on Antimicrobial Stewardship and Antibiotic Overuse
COVID-19 Impact on Antimicrobial Stewardship and Antibiotic Overuse • AMR infections are estimated to cause 700,000 deaths annually worldwide - This number is projected to increase to 10 million per year by 20501 • Data on antibiotic prescribing in COVID-19 patients has ranged from 58-100%2-6 • Wide
Slide 14: Role of T2 in Diagnosis of Secondary Bacterial and Fungal Infections in COVID-19 Patients
Role of T2 in Diagnosis of Secondary Bacterial and Fungal Infections in COVID-19 Patients 14
Slide 15: Our Comprehensive Product Portfolio is Simple to Use
Our Comprehensive Product Portfolio is Simple to Use Fully-automated T2Dx Instrument • Fast: Results in 3-5 hours • Easy: no sample preparation Sensitivity: 91.1% Se9.4%2 2 2 Sensitivity: 95.4%1 1 Sensitivity: 95.8% Specificity: 99.4% Specificity: 98.0%1 1 Specificity: 98.1% • Sensitive: ~1 CFU/mL L
Slide 16: Why Wait Days for Results?
Why Wait Days for Results? T2 Biosystems’ diagnostic panels are the only FDA-cleared tests that provide species identification, directly from whole blood and within 3-5 hours of the first blood draw, which is often before the second dose of broad-spectrum antibiotics is delivered, enabling clinician
Slide 17: Resistance
T2MR & Blood Culture Results Influence Therapy Day 1 Day 2 Day 3 Day 4 Day 5 TIME (# of days) Empiric Rx AST Antibiotic Rx Species & Resistance Directed Therapy Directed Therapy ID Species & Resistance T2MR Based Tests Blood Culture Dx Gram Species & AST Await results (used for off-panel species) In
Slide 18: Role of T2: Who to Test for Secondary Infections
Role of T2: Who to Test for Secondary Infections • Testing populations provided by current T2Candida and T2Bacteria customers - COVID-19 Patients Admitted to the ICU - COVID-19 Patients experiencing new fever/deterioration - Critically ill/septic patients who are negative for COVID-19 - Others per i
Slide 19: T2SARS-CoV-2 Panel – in Development
T2SARS-CoV-2TM Panel – in Development • T2 Biosystems recently entered into a worldwide licensing agreement for a rapid COVID-19, novel coronavirus test developed by the Center of Discovery and Innovation at Hackensack Meridian Health, which is currently in use under EUA guidelines • The proprietary
Slide 20: Conclusions
Conclusions • Secondary infections, including antimicrobial resistant infections, are likely to occur in a clinically significant proportion of hospitalized patients with COVID-19 • Highest risk is likely in ventilated patients with longer stay and higher severity of illness • Stewardship will be cr
Slide 21: Thank You and Questions
Thank You and Questions For additional information on T2 Biosystems and our diagnostic portfolio, please visit our website (www.t2biosystems.com) or email us at info@t2biosystems.com.