T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid
detection of sepsis-causing pathogens and antibiotic resistance
genes, announced today the formation of its Scientific Advisory
Board (SAB), comprising leading clinicians and researchers in the
areas of infectious disease, laboratory medicine, and pharmacy. The
newly formed SAB will provide insights regarding T2 Biosystems’
clinical utilization, product pipeline, preclinical development,
clinical research, clinical data generation, and strategic guidance
to advance the Company’s mission.
"We are honored to collaborate with a
prestigious group of scientific thought leaders and industry
experts who share our mission to fundamentally change the way
medicine is practiced through transformative culture-independent
diagnostics,” stated John Sperzel, Chairman and CEO of T2
Biosystems. “We look forward to their scientific, clinical and
strategic insights as we seek to advance our technology platform
and improve the standard of care for patients at risk of
sepsis.”
The SAB is chaired by Aparna Ahuja, M.D., Chief
Medical Officer of T2 Biosystems, the inaugural meeting was held
during the first quarter of 2022, and the inaugural members
include:
Sean X. Zhang, M.D., Ph.D.,
D(ABMM)Dr. Zhang is an Associate Professor of Pathology at
the Johns Hopkins University School of Medicine and the Medical
Director of Medical Mycology Laboratory at the Johns Hopkins
Hospital. Dr. Zhang's research focuses on developing rapid and
nonculture-based tools for fungal diagnostics. These include
identifying fungal pathogens from FFPE tissue blocks, fungal
antigen assays, host-driven response assays, multiplex PCR and
next-generation sequencing to rapidly identify fungal pathogens
directly from clinical samples. He is also interested in studying
identification and characterization of new emerging fungal
pathogens, the role of fungal pathogens in cystic fibrosis
patients, and antifungal drug resistance. Dr. Zhang is an Executive
Editor of Medical Mycology and an Editorial Board Member of the
Clinical Microbiology Reviews. He is a Section Editor (Mycology)
for the Manual of Clinical Microbiology (13th Edition). He serves
as an advisor to the Clinical and Laboratory Standards Institute
(CLSI) Antifungal Susceptibility Testing subcommittee and a member
of the College of American Pathologist (CAP) Microbiology
Committee. He is also a co-chair of recently created Fungal
Diagnostics Laboratory Consortium (FDLC) in the USA/Canada. Dr.
Zhang holds an M.D. from Shanghai Jiao Tong University School of
Medicine in China and a Ph.D. in microbiology and immunology from
the University of Turku in Finland. He completed a clinical
fellowship in Medical Microbiology at the University of Toronto in
Canada.
Thomas J. Walsh, M.D., Ph.D. (hon), FIDSA, FAAM,
FECMMDr. Thomas J. Walsh serves as the Founding Director
of the Center for Innovative Therapeutics and Diagnostics (IITD),
Henry Schueler Foundation Scholar, Investigator of Emerging
Infectious Diseases of the Save Our Sick Kids Foundation, and
Adjunct Professor of Medicine, Microbiology, and Immunology,
University of Maryland School of Medicine. Previously, Dr. Walsh
spent 12 years as Founding Director of the Weill Cornell
Transplantation-Oncology Infectious Diseases Program, and 23 years
at National Cancer Institute. As the author of more than 1,100
publications and investigator for more than 100 clinical studies,
he and his program laid the scientific foundation for major
advances and standards of care in diagnosis, treatment, and
prevention of invasive mycoses in immunocompromised pediatric and
adult patients with cancer and stem cell transplantation. In
response to the global public health crisis of multidrug resistant
Gram-negative bacterial infections, he and his staff during the
past two decades also expanded their clinical research and
laboratory investigations to develop new antimicrobial therapeutic
agents and diagnostic systems in novel model systems leading to
clinical trials against these life-threatening diseases. Dr. Walsh
and his colleagues are further studying the T2-Biosystem and cell
free metagenomics to identify invasive fungal and bacterial
infections earlier in the course of infection to allow for early
targeted antimicrobial therapy. His professional memberships
include Councilor of the International Immunocompromised Host
Society (ICHS), Co-Chair of the ICHS Medical Mycology Training
Initiative, President-elect of the Medical Mycology Society of the
Americas, Risk Group I Chair of the Bacteriology and Mycology Study
Group, and Chair of the NCI Animal Care and Use Committee. Dr.
Walsh holds a M.D. from The John Hopkins University School of
Medicine and is board certified in Medicine, Infectious Diseases,
and Medical Oncology. He was the first recipient of the Janssen
Medical Mycology Fellowship from the National Foundation for
Infectious Diseases.
Denise L. Uettwiller-Geiger, Ph.D., DLM
(ASCP), Dr. Uettwiller-Geiger is a Clinical Chemist and
Clinical Transformation Liaison for Mather Hospital Northwell
Health, Port Jefferson, New York. Dr. Uettwiller-Geiger serves as a
clinical liaison to clinicians providing expert education,
guidance, and consultation for laboratory testing. She is the
author of more than 100 clinical journal articles, has been the
recipient of numerous awards and is an experienced speaker, who has
participated in many presentations, webcasts, workshops, and press
conferences. In recognition of her significant contributions to
Laboratory Medicine, she was selected as one of six finalists for
the Cardinal Health urEssential Laboratorian of the Year award in
May of 2018 and in 2021 Mather’s Choosing Wisely Committee was
recognized for their initiatives by the American Society of
Clinical Pathology and received their Choosing Wisely Champion
award. Dr. Uettwiller-Geiger received her Master of Health Science
from Stony Brook University, Stony Brook, New York and an Advanced
Certificate in Health Care Management, from the W. Averell Harriman
School for Policy and Management, from Stony Brook University,
Stony Brook, New York, and a Ph.D. in biomedical science from
Pacific Western University, Brentwood, California.
James W. Snyder, Ph.D., DABMM,
FAAM, Dr. Snyder is the Director of Microbiology and
Infectious Diseases Molecular Diagnostic Laboratory at the
University of Louisville Hospital. He holds the academic rank of
Professor of Pathology and Laboratory Medicine in the Department of
Pathology and Laboratory Medicine, University of Louisville School
of Medicine. His memberships in professional societies include the
American Society for Microbiology (ASM), Pan American Society for
Clinical Virology, Infectious Disease Society of American (IDSA),
and the South Central Association for Clinical Microbiology
(SCACM). Dr. Snyder’s specialties include medical mycology,
bioterrorism, and molecular diagnostics of infectious diseases. In
addition, he maintains an active research program focusing on
clinical trials and technology/product assessment in addition to
teaching pathology residents, infectious disease fellows, and
medical students. Dr. Snyder earned a Ph.D. in Biology (Medical
Microbiology from the University of Dayton.
Michael J. Rybak, Pharm.D., M.P.H.,
PH.D., FCCP, FIDSA, FIDP, Dr. Rybak is Professor of
Pharmacy, Department of Pharmacy Practice, Director, Anti-Infective
Research Laboratory, Eugene Applebaum College of Pharmacy &
Health Sciences, Wayne State University. He is also adjunct
Professor of Medicine, Division of Infectious Diseases, School of
Medicine at Wayne State University and Adjunct Clinical Professor
at the University of Michigan College of Pharmacy. His research
focus is antimicrobial pharmacokinetics and pharmacodynamics
(PK/PD) and the assessment of infectious diseases health outcomes
including their relationship to bacterial resistance. His most
recent work is focused on the laboratory and clinical outcomes
assessment of combination antibiotic therapy including bacterial
phages for methicillin and vancomycin-resistant Staphylococcus
aureus, enterococcus and multi-drug resistant
gram-negative pathogens. Dr. Rybak is a member of the antimicrobial
stewardship committee at Detroit Medical Center, and he is funded
by the National Institute for Allergy and Infectious Diseases
(NIAID) and via several investigator initiated grants from
Pharmaceutical Industry. Dr. Rybak earned a BS in Pharmacy from
Northeastern University, a Pharm.D. and a M.P.H. from Wayne State
University, and a Ph.D. in Public Health and Epidemiology from
Walden University.
George Pankey, M.D., Dr. Pankey
is Director, Infectious Disease Research at the Ochsner Clinic
Foundation in New Orleans and Clinical Professor of Medicine at
Tulane. Dr. Pankey is an internationally recognized and honored
expert in the field of infectious diseases, and his research
focuses on the diagnosis and treatment of antimicrobial resistant
bacterial and fungal infections. He is a Master and Laureate award
recipient of the American College of Physicians and a Fellow and
Clinician of the Year award recipient of the Infectious Disease
Society of America. Dr. Pankey earned his BS and MD from Tulane
University and completed his internal medicine training at the
University of Minnesota where he also earned a MS in medicine,
microbiology, and immunology.
M. Hong Nguyen, M.D., Dr.
Nguyen is Professor of Medicine and Co-Director of the Center for
Healthcare Mycology at the University of Pittsburgh, as well
as Director of the Transplant Infectious Diseases (TID) and
Antimicrobial Management Programs (AMP) at the University of
Pittsburgh Medical Center (UPMC). Her longstanding research
interests are in epidemiology of invasive fungal infections;
antifungal drug resistance and pharmacokinetics; and non-culture
diagnostics. Over the past ten years, she has expanded her research
into multi-drug resistant (MDR) bacteria. Dr. Nguyen has authored
over 240 papers in the peer-reviewed literature on wide-ranging
clinical, translational and basic research topics in infectious
diseases. Her lab has active research projects investigating
molecular mechanisms of pathogenesis and antifungal resistance
among Candida spp., evolution of carbapenem-resistant Klebsiella
pneumoniae strains recovered from patients receiving antimicrobial
treatment, and antimicrobial
pharmacokinetics-pharmacodynamics. In 2021, she was among the
0.1% of world's scientists recognized by Clarivate Analytics as a
Highly Cited Researcher, based on number of papers that rank in the
top 1% of Web of Science citations by discipline. Dr. Nguyen earned
a B.S. in Chemistry and Physics from Elizabeth College and holds an
M.D. from Temple University School of Medicine.
Randall T. Hayden, M.D., Dr.
Hayden is Director of the Division of Clinical Pathology and Global
Pathology and Director of Clinical and Molecular Microbiology in
the Department of Pathology at St. Jude Children’s Research
Hospital. His research interests focus on the application of
molecular methods to diagnostic challenges in clinical
microbiology, with particular emphasis on the diagnosis of
infections in the immunocompromised host. He is editor-in-chief of
Diagnostic Microbiology of the Immunocompromised Host, 2nd Edition;
co-editor of Molecular Microbiology, Diagnostic Principles and
Practice, 3rd Edition and of Medically Important Fungi, 6th
Edition; and section editor for the Manual of Clinical
Microbiology, 12th Edition, all from ASM Press. He serves as
associate editor for the Journal of Clinical Microbiology and is
past-president of the Pan-American Society for Clinical Virology
(PASCV). Dr. Hayden holds a M.D. from the University of Illinois
College of Medicine.
About T2 BiosystemsT2
Biosystems, a leader in the rapid detection of sepsis-causing
pathogens and antibiotic resistance genes, 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, which are powered by the Company’s
proprietary T2 Magnetic Resonance (T2MR®) technology, include the
T2Dx® Instrument, the T2Candida® Panel, the T2Bacteria® Panel, the
T2Resistance® Panel, and the T2SARS-CoV-2™ Panel. T2 Biosystems has
an active pipeline of future products, including the T2Biothreat
Panel, the T2Cauris™ Panel, the T2Lyme™ Panel, as well as
additional products for the detection of bacterial and fungal
pathogens and associated antimicrobial resistance markers, and
biothreat pathogens.
Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
All statements contained in this press release that do not relate
to matters of historical fact should be considered forward-looking
statements, including, without limitation, statements regarding our
revenue results and cash balance, financial outlook, timing of
filing of an FDA submission, anticipated strategic priorities,
product demand, commitments or opportunities, and growth
expectations or targets, as well as statements that include the
words “expect,” “intend,” “plan”, “believe”, “project”, “forecast”,
“estimate,” “may,” “should,” “anticipate,” and similar statements
of a future or forward looking nature. These forward-looking
statements are based on management’s current expectations. These
statements are neither promises nor guarantees, but involve known
and unknown risks, uncertainties and other important factors that
may cause actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements, including, but not limited to, (i) any inability to (a)
realize anticipated benefits from commitments, contracts or
products; (b) successfully execute strategic priorities; (c) bring
products to market; (d) expand product usage or adoption; (e)
obtain customer testimonials; (f) accurately predict growth
assumptions; (g) realize anticipated revenues; (h) incur expected
levels of operating expenses; or (i) increase the number of
high-risk patients at customer facilities; (ii) failure of early
data to predict eventual outcomes; (iii) failure to make or obtain
anticipated FDA filings or clearances within expected time frames
or at all; or (iv) the factors discussed under Item 1A. “Risk
Factors” in the company’s Annual Report on Form 10-K for the year
ended December 31, 2021, filed with the U.S. Securities and
Exchange Commission, or SEC, on March 23, 2022, and other filings
the company makes with the SEC from time to time. These and other
important factors could cause actual results to differ materially
from those indicated by the forward-looking statements made in this
press release. Any such forward-looking statements represent
management’s estimates as of the date of this press release. While
the company may elect to update such forward-looking statements at
some point in the future, unless required by law, it disclaims any
obligation to do so, even if subsequent events cause its views to
change. Thus, no one should assume that the Company’s silence over
time means that actual events are bearing out as expressed or
implied in such forward-looking statements. These forward-looking
statements should not be relied upon as representing the company’s
views as of any date subsequent to the date of this press
release.
Media Contact:Meagan Dominick, Vault
Communicationsmdominick@vaultcommunications.com773-369-4255
Investor Contact:Philip Trip Taylor, Gilmartin
Groupir@T2Biosystems.com 415-937-5406
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