A conversation with Sandy J. Estrada, PharmD, Vice President of Medical Affairs, T2 Biosystems

Oct. 24, 2019

Please share with our readers how you arrived at your current career. After working in a microbiology research lab in pharmacy school, I solidified my interest in infectious disease specialization. During my 13 years working at Lee Health System, I learned how important it is to rapidly diagnose and treat infections, and that the industry today does not have enough antibiotics to treat patients appropriately.

I knew that by transitioning into a different role, I would be able to make an impact on a larger scale for patients and their clinical outcomes. I could assist with the development and implementation of the company’s products at other facilities, where antimicrobial stewardship programs are a top priority.

As a Doctor of Pharmacy, what has been your experience venturing into other areas of healthcare? I’ve had positive experiences in both hospital and corporate settings, which I attribute to the many staff members I’ve met along the way. Early on in pharmacy school and residency, I learned that a multidisciplinary approach to everything healthcare professionals do is necessary in order to be successful, regardless of specialty area.

In my role as the co-director of antimicrobial stewardship and director of the Infectious Disease Pharmacy Residency Program at Lee Health System, for example, I had committee representation from lab administrators, directors from each hospital, critical care pharmacists, physicians, hospitalists, infection prevention staff members and IT employees. Similarly, in my current position, I find that collaboration across disciplines is critical for tackling initiatives like the implementation of antimicrobial stewardship protocols and technologies, as well as for developing and refining innovations.

For those not familiar, what can you tell us about T2 Biosystems? We are a rapid diagnostic technology company that looks to improve clinical outcomes and reduce healthcare costs by getting patients started on the right therapy faster. Its primary focus is early detection of pathogens in bloodstream infections, which can lead to sepsis and the overuse of antimicrobial drugs; both of which are key drivers in high mortality rates and the rise of antimicrobial resistance, respectively.

T2 Biosystems has the first FDA-cleared diagnostic panel requiring no blood culture for testing sepis. However, isn’t there another test that is similar? The T2Candida and T2Bacteria Panels test for sepsis-causing pathogens, confirming if a patient has pathogens in their bloodstream that are causing an infection and if so, what those pathogens are. Early information is essential for making quick, accurate clinical decisions for next steps, which can ultimately make a significant impact on patients’ clinical outcomes.

The two different panels reflect the types of pathogens that can cause a bloodstream infection, which can be bacterial or fungal. Both can be run on the same T2Dx Instrument.

 T2 Biosystems also has the only IVD test to receive NTAP approval by CMS. What was the application process like? This designation means that U.S. hospitals treating Medicare inpatients with sepsis will now be eligible for a new technology add-on payment (NTAP), in addition to the standard payment amount. The rigorous application process took over a year. We were required to prove three things about the technology: (1) it is unlike anything else on the market today, (2) it helps treats patients associated with high costs, and (3) it demonstrates substantial clinical improvement in patients.

Within their final rule, CMS stated that “the T2Bacteria Test Panel represents a substantial clinical improvement over existing technologies because it reduces the proportion of patients on inappropriate therapy, thus reducing the rate of subsequent diagnostic or therapeutic intervention, as well as length of stay and mortality rates caused by sepsis causing bacterial infections.”  

Diagnostic times are faster and can be applied clinically in an improved treatment manner. Discuss this technology and how it supports better patient care. T2 Magnetic Resonance (T2MR) technology powers all of the diagnostic innovations at the company. It’s the first and only FDA-cleared detection technology that can quickly, and accurately, identify bacterial or fungal pathogens directly from whole blood without the need for purification or extraction of target molecules from the sample, and without a positive blood culture.1

With conventional diagnostic tools, clinicians start patients on broad-spectrum antimicrobial therapy without knowing which pathogen has infected the patient. Once they get the pathogen results, they adjust treatment. By identifying the pathogen faster, clinicians can start patients on the right therapy sooner, which has a multitude of benefits.

Are there any new enhancements and/or technologies in the pipeline that you can share? This past September we initiated a program to significantly expand the company’s current portfolio of diagnostics for sepsis-causing pathogens and antibiotic-resistance genes. Most notably, this includes bringing to market a panel that detects 13 gram-negative and gram-positive resistance genes direct from whole blood in three to five hours. It also includes the detection of the most clinically important carbapenem resistance genes, which are listed on the CDC Urgent Threat list for antibiotic resistance.


1. Nguyen, et al. Annals Internal Medicine 2019. https://annals.org/aim/article-abstract/2733498/performance-t2bacteria-panel-diagnosing-bloodstream-infections-diagnostic-accuracy-study