Inflammatix Secures FDA Authorization for Groundbreaking TriVerity Sepsis Test System
Sunnyvale, CA-based Inflammatix has achieved a important milestone with the U.S. Food adn Drug administration (FDA) granting marketing authorization for its TriVerity rapid sepsis test system. This innovative point-of-care molecular test is poised to revolutionize sepsis diagnosis by sidestepping conventional blood culture methods.
The TriVerity system leverages artificial intelligence (AI) to measure mRNA expression, combining bacterial-viral infection scoring with a severity risk evaluation. by analyzing the expression levels of 29 genes linked to the host immune response, the system generates three critical scores: the likelihood of bacterial infection, viral infection, and severe illness. Severe illness is defined by the need for mechanical ventilation, vasopressors, or renal replacement therapy within seven days.
Dr. Tim Sweeney, PhD, CEO and Co-Founder of Inflammatix, emphasized the limitations of existing tests. “The essential problem with existing tests is an outdated focus on labeling patients as ‘septic or not,'” he said.”But sepsis is a syndrome, not a disease, and its definition keeps changing. We thus designed TriVerity to look at its clinically actionable core elements: (1) does this patient have an infection, and (2) how sick are they likely to become?”
The FDA’s authorization follows the breakthrough device designation awarded to TriVerity in November 2023. The system,which includes the Myrna instrument and the test,was evaluated based on results from the Sepsis Shield study.
Inflammatix’s journey to this achievement has been bolstered by considerable financial backing. In September 2024, the company raised $57 million in Series E financing, led by Khosla Ventures and Think.Health Ventures, with participation from Northpond Ventures, D1 Capital Partners, Iberis Capital, Vesalius BioCapital, OSF Healthcare, and RAW ventures. This funding round brought the total private capital raised to over $200 million. Additionally, Inflammatix has secured at least $50 million in grants and contracts from government agencies, including the U.S. Biomedical advanced Research and Advancement Authority, and various foundations.
Key highlights of the TriVerity System
| Feature | Details |
|—————————|—————————————————————————–|
| Technology | AI-driven mRNA expression analysis |
| genes Analyzed | 29 genes associated with host immune response |
| Output | Bacterial infection, viral infection, and severe illness risk scores |
| FDA Designation | Breakthrough device (november 2023) |
| Funding | $57 million Series E, total private capital exceeds $200 million |
The TriVerity system represents a paradigm shift in sepsis diagnosis, offering clinicians actionable insights to improve patient outcomes. With its FDA authorization,Inflammatix is set to make a profound impact on the healthcare landscape.
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Headline:
Revolutionizing Sepsis Diagnosis: An Interview with Dr. Laura Jenkins on InflammatixS FDA-Approved TriVerity System
Introduction:
In a significant breakthrough in medical diagnostics,Sunnyvale-based Inflammatix has received FDA authorization for its innovative TriVerity rapid sepsis test system.This groundbreaking technology, powered by artificial intelligence, promises to transform sepsis diagnosis and patient care. Today, we sit down with Dr. Laura Jenkins, a renowned infectious disease specialist and expert in sepsis management, to discuss the implications of this remarkable achievement.
The TriVerity System: A Paradigm shift in Sepsis Diagnosis
Senior Editor (SE): Dr. Jenkins, can you start by explaining what makes the TriVerity system such a game-changer in sepsis diagnosis?
Dr.Laura Jenkins (LJ): Absolutely.Sepsis is a complex condition that requires swift and accurate diagnosis. Customary methods,like blood cultures,are time-consuming and often inconclusive. The TriVerity system, however, offers a rapid, molecular test that provides not just a binary ‘septic or not’ result, but a comprehensive assessment of infection type and severity. It’s a significant step forward.
beyond ‘Septic or Not’: The Clinical actionability of TriVerity
SE: Inflammatix’s CEO, Dr. Tim Sweeney, emphasized the need to look at sepsis’ clinically actionable core elements. How does TriVerity address this?
LJ: Exactly. Sepsis is a syndrome, not a disease, and its definition keeps evolving. TriVerity doesn’t just tell us if a patient is septic; it helps us understand what type of infection they have and how sick they’re likely to become. This actionable information allows clinicians to tailor treatment plans more effectively, potentially improving patient outcomes.
The Role of AI in Sepsis Diagnosis
SE: The TriVerity system leverages artificial intelligence to measure mRNA expression. How does this technology enhance our ability to diagnose and manage sepsis?
LJ: AI allows the system to analyze a vast amount of data – in this case, the expression levels of 29 genes linked to the host immune response. By interpreting these complex patterns, the system can generate accurate, actionable scores for bacterial infection, viral infection, and severe illness risk. This level of precision and sophistication is simply not achievable with human analysis alone.
The FDA’s Breakthrough Device Designation and the Sepsis Shield Study
SE: The FDA’s Breakthrough Device designation and the positive results from the Sepsis Shield study have certainly bolstered confidence in the TriVerity system. Can you tell us more about these milestones?
LJ: Indeed. The Breakthrough Device Designation is a testament to the system’s potential to address unmet clinical needs. The Sepsis Shield study,simultaneously occurring,provided robust clinical evidence supporting triverity’s accuracy and reliability. These milestones have been crucial in paving the way for FDA authorization.
Inflammatix’s Journey and the Future of Sepsis Diagnosis
SE: Inflammatix has received significant financial backing, with a Series E financing round raising $57 million. How has this support contributed to the company’s success, and what does the future hold for sepsis diagnosis?
LJ: Inflammatix’s journey has been bolstered by considerable financial and strategic backing. This support has allowed the company to invest in research, progress, and clinical validation, ultimately leading to this FDA authorization. looking ahead, I believe we’ll see more innovative, AI-driven technologies like triverity transforming sepsis diagnosis and patient care.
Final Thoughts
SE: Dr. Jenkins, thank you for sharing your insights on the TriVerity system and its potential to revolutionize sepsis diagnosis. It’s an exciting time for medical technology!
LJ: My pleasure. I’m truly excited about the future of sepsis diagnosis and the role that innovative technologies like TriVerity will play in improving patient outcomes.
