T2 Biosystems (NASDAQ:TTOO) has announced significant progress in its diagnostic pipeline, focusing on direct-from-blood tests for critical conditions including antimicrobial resistance (AMR), pediatric Candida infections, Lyme disease, and Candida auris. The company anticipates launching multiple new products in 2024 and 2025, with several pipeline products already receiving FDA Breakthrough Device designation. These advancements aim to provide faster, more accurate diagnoses, potentially improving patient outcomes and reducing healthcare costs.
T2Resistance Panel: Addressing Antimicrobial Resistance
Antimicrobial resistance is a growing global threat, and T2 Biosystems is tackling this challenge with its T2Resistance Panel. This direct-from-blood molecular diagnostic test, designed for use with the FDA-cleared T2Dx Instrument, simultaneously detects 13 antibiotic resistance genes within 3-5 hours, eliminating the need to wait days for blood culture results. A study published in the Journal of Clinical Microbiology demonstrated the panel's high accuracy (94.7% sensitivity and 97.4% specificity) and rapid turnaround time (4.4 hours compared to 58.3 hours for traditional methods). The study also highlighted the clinical impact, with interventions occurring in 41% of patients tested. T2 Biosystems plans to submit a 510(k) premarket notification to the FDA in Q4 2024 and expects prioritized review given the Breakthrough Device designation.
Expanding Pediatric Sepsis Detection
Sepsis remains the leading cause of death in hospitalized children, surpassing even cancer. To combat this, T2 Biosystems is pursuing pediatric claims for its T2Candida Panel and T2Bacteria Panel. These are the only FDA-cleared products capable of detecting sepsis-causing fungal and bacterial pathogens directly from blood in just 3-5 hours, without the need for lengthy blood cultures. A study in the Journal of Clinical Microbiology (2022) found that the T2Candida Panel reduced the time to species identification by 121.8 hours compared to blood culture in pediatric patients with suspected fungal bloodstream infections. The company has already submitted a 510(k) premarket notification to the FDA to expand the use of the T2Candida Panel to include pediatric testing and plans to submit a similar notification for the T2Bacteria Panel.
T2Lyme Panel: Early Detection of Lyme Disease
Lyme disease, the most common vector-borne disease in the U.S., affects an estimated 3.4 million people annually, costing nearly $500 million in testing. Current diagnostic methods rely on antibody tests that are often inaccurate in the early stages of infection (4-8 weeks post-infection). T2 Biosystems' T2Lyme Panel aims to address this unmet need with a direct-from-blood molecular diagnostic test for the early detection of Borrelia burgdorferi, the bacterium causing Lyme disease. The T2Lyme Panel is designed to detect infection within the first 30 days, significantly earlier than antibody tests, enabling prompt treatment and preventing chronic complications. T2 Biosystems plans to launch the T2Lyme Panel as a Laboratory Developed Test (LDT) and has decided to build or buy its own laboratory to commercialize the test. While this decision may delay the launch beyond Q3 2024, the company believes it will result in higher profit margins and greater control over its Lyme disease business. The company intends to submit a 510(k) premarket notification to the FDA and expects prioritized review given the Breakthrough Device designation.
Addressing the Threat of Candida auris
Candida auris, a multidrug-resistant fungus, poses a significant threat to public health, with mortality rates as high as 60%. T2 Biosystems intends to expand its T2Candida Panel to include the detection of Candida auris. The current T2Candida Panel covers approximately 90% of Candida species commonly found in bloodstream infections, and the addition of Candida auris will provide crucial coverage against this increasingly prevalent pathogen. T2 Biosystems previously collaborated with the CDC on the feasibility and early development of a diagnostic test for Candida auris and is pursuing non-dilutive funding to complete the development, validation, and clinical studies. The FDA has granted the T2 Candida auris test Breakthrough Device designation, and the company anticipates a prioritized review upon submission of a 510(k) premarket notification to the FDA.
