Torus Biosystems, a medtech startup that spun out of Harvard’s Wyss Institute for Biologically Inspired Engineering, has developed the Synestia system, a point of care diagnostic tool for infectious disease. The system aims to provide rapid, point-of-care identification of pathogens, and incorporates microarray and qPCR technology.
The company reports that the system allows a clinician to run multiple tests on one device to detect all the pathogens associated with a specific disease. The run-time is rapid, with the device providing results in as little as 30 minutes, and for each sample over 1000 targets can be probed. Pathogen lysis and DNA/RNA extraction and purification all occur on-board.
The COVID-19 pandemic has highlighted the need for rapid and reliable diagnostic technologies. The Synestia system can detect any pathogen, including the causative virus for COVID-19, as long as there is a nucleic acid sequence available that uniquely identifies it.
See a video about the technology below.
Torus Biosystems recently attracted $25 million in financing. Medgadget had the opportunity to speak with Shawn Marcell, CEO of Torus Biosystems about the Synestia system.
Conn Hastings, Medgadget: Please give us a quick overview of infectious disease, and the burden it poses for society.
Shawn Marcell, Torus Biosystems: Infectious diseases are disorders caused by microbes such as bacteria, viruses, fungi, and parasites that are easily passed from one person to another. Some examples include the flu, HIV/AIDS, Ebola, tuberculosis, and COVID-19. With regard to the burden posed by infectious diseases, consider what we’ve all incurred over the last year due to the COVID-19 pandemic. Schools and businesses closed, travel was restricted, and many people remained at home resulting in economic hardships, stressed healthcare systems, and mental health issues. COVID-19 is just one of many infectious diseases, and it alone essentially brought life as we know it to a screeching halt. The World Health Organization reports that globally over 17 million people die each year due to infectious diseases.
Medgadget: How are infectious pathogens traditionally identified? How is this suboptimal?
Shawn Marcell: Traditionally, infectious pathogens are identified through culturing. For example, if a urinary tract infection is suspected, a urine sample is collected and then placed in conditions that encourage growth of microorganisms for 1-2 days. If there is growth, the specific organism is identified using a microscope. For specific therapy guidance, an additional antimicrobial susceptibility test that takes another day may follow to determine the best treatment course.
Culturing is suboptimal primarily due to the prolonged time to results and unreliability of results. Clinicians are stuck guessing for 1-3 days while waiting for definitive culture results. And those definitive results may never come from the lab because culture often misses the causative pathogen. This waiting game results in both poor antibiotic stewardship due to the inappropriate use of antibiotics and suboptimal patient outcomes.
Medgadget: Please give us an overview of syndromic testing.
Shawn Marcell: Syndromes are a group of symptoms that consistently occur together. Historically, clinical labs employed multiple different analytical approaches to maximize broad pathogen detection associated with a specific syndrome. Since the early 21st century, innovative multiplex molecular in vitro diagnostic assays (IVDs) have become available, and these IVDs are capable of detecting a broad array of pathogens that together may cause a single clinical syndrome. This became known as the syndromic panel approach to pathogen testing.
Medgadget: How does the point-of-care system developed by Torus Biosystems work? Please give us an overview of the DNA/RNA detection technology at the heart of the system.
Shawn Marcell: The Torus Synestia System works by seamlessly integrating convection-based qPCR, a wash-free microarray, and proprietary toehold probes. When a specimen is introduced to the system, pathogen cells are lysed, DNA/RNA is extracted, purified, and presented in the reaction chamber. All reagents and the microarray are included in the closed chamber. As thermal cycling occurs, amplified target sequences hybridize to the microarray and a fluorescent signal is detected by the system’s optical module. For each sample, over 1000 targets can be simultaneously detected in under 30 minutes.
Medgadget: What types of pathogens can the system detect? Is it useful during the COVID-19 pandemic?
Shawn Marcell: The Torus Synestia System can detect any pathogen. All we need is the unique nucleic acid sequence to essentially fingerprint that specific pathogen. COVID-19 is caused by the SARS-CoV-2 virus. The Torus Synestia System can detect SARS-CoV-2 and can differentiate all variants and mutant strains, such as that from the UK, and identify other known coronaviruses, RSV, and Flu A/B. Torus expects to make this panel available for public health purposes.
Medgadget: What inspired you to develop such a system? How will this latest round of financing help make your technology available to clinicians?
Shawn Marcell: I’ve been around the block a few times in medical diagnostics and know the clear need for better quality diagnostic information at the point of care. The Torus technology was introduced to me while I was an Entrepreneur in Residence at the Wyss Institute of Harvard University. Knowing the challenges faced by other manufacturers in the syndromic testing space, I saw the clear potential to impact healthcare and patient outcomes. And this sentiment was echoed by investors participating in our recently closed Series A financing round. The funding will bolster our development efforts so we can accelerate the timeline for making this technology widely available.