CHARLOTTE, North Carolina (GenomeWeb) – T2 Biosystems this week presented data at the Association for Molecular Pathology meeting on the cost savings associated with its T2Candida sepsis panel.
The T2Candida panel — which can take a clinician from sample to result in around four hours — can not only improve patient care but can dramatically reduce costs associated with hospital stay times and antifungal therapies, John McDonough, CEO of T2 Biosystems, told an audience at AMP.
"Time is critically important not only for the patient, but also for economics," McDonough said. "The data show that for every hour that you can improve and get a patient onto the correct targeted drug, you can reduce the mortality rate by 7 to 8 percent."
McDonough cited data from a cost effectiveness study that was conducted by pharmacists and pathologists at Henry Ford Hospital in Detroit, Michigan. The investigators reported an average cost saving of around $25,000 for each patient with candidemia tested using the T2Candida panel. The projected annual cost savings for 110 patients would be in the range of $2.0 million to $3.1 million.
Henry Ford Hospital staff presented the information at the end of October at IDWeek 2016, the combined annual meeting of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
They reported that the time to identification from blood draw to a positive result was 7.1 hours and the time to active therapy was 13.4 hours. The T2 panel reduced the average time to diagnosis per patient by around 16 hours and the time to appropriate antifungal therapy by 13 hours, McDonough said.
Importantly, candidemic patients experienced an average reduction in length of hospital stay of four days, and an average reduction in the length of time for patients in the intensive care unit of seven days, he added.
"Hospitals are adjusting to a new world of changes that are taking place throughout healthcare," McDonough said. "This is being driven by the need to add more and more people to the healthcare system and by a system that’s under tremendous cost pressure."
He added that Medicare adjustments implemented in 2016 resulted in a 1.75 percent reduction in reimbursements and a shift toward rewarding hospitals based on the quality of care they provide.Â
With these market drivers in mind, the team at T2 Biosystems had already decided to develop products that would cater to a need to improve quality of care and show savings, he added.
And that’s why sepsis — one of the most expensive hospital-treated conditions — became the company’s first area of focus.
T2’s Candida test for detection of sepsis received US Food and Drug Administration clearance two years ago. The T2Candida panel, which runs on the firm's miniaturized, magnetic resonance-based technology platform, identifies the five clinically relevant species of Candida directly from whole blood — C. albicans, C. tropicalis, C. parapsilosis, C. krusei, and C. glabrata.
The company is also developing a bacterial sepsis panel called T2Bacteria that it expects will detect pathogens in three to five hours. T2 expects that it will complete clinical trials on the panel and file for FDA approval in mid-2017.Â
Combining empiric, broad-spectrum drug therapy with targeted treatments based on Candida and bacterial diagnostics will cover 95 percent of patients with infections that could lead to sepsis, Will Harris, director of product management for T2Biosystems, told GenomeWeb at AMP.
He added that T2’s technology was suited to analyzing multiple types of specimens including urine as well as blood, but that the firm’s focus is on diagnosis of blood samples because of the high level of specificity and sensitivity needed for that type of test and the related capabilities of the T2 instruments and assays.
T2 has multiple competitors in the market for sepsis testing. A number of companies, including Roche, BioMérieux, OpGen, DNAe, Sepset, and Accelerate Diagnostics, are either developing or marketing advanced sepsis detection systems. As a result, physicians have available an array of technologies and products ranging from molecular tests to biomarkers.
T2 recently announced that it partnered with Allergan to develop a novel diagnostic panel for the detection of Gram-negative bacterial species and antibiotic resistance in patients with severe bacterial infections.
Under the terms of the deal, T2 stands to receive up to $4 million in milestone payments related to the development of the antibiotic resistance panel and an expansion of T2Bacteria.
T2 said recently that it believes Allergan intends to use the T2Bacteria panel in its development and clinical trial efforts.
At AMP this week, T2Biosystems said the collaboration would result in one of the first direct-from-blood bacterial panels developed specifically for carbapenem resistance, and as part of the agreement, Allergan was given an option to co-market the T2 diagnostic product in hospitals.
Harris said that Allergan recognizes that an effective way to deliver value to hospitals is to combine sensitive and rapid diagnostic information with the delivery of therapeutics.
In September, T2 Biosystems bolstered its cash position through an equity investment and presented data on a Lyme disease test that it views as an important piece of its product pipeline.
A $40 million investment from Canon USA represented a 19.9 percent stake in the molecular diagnostics company.
Canon and T2 have been partners since early 2015 when they struck a deal to develop a diagnostic test panel based on T2's technology for the rapid detection of Lyme disease.
At the Diagnostic Tests for Lyme Disease Conference in Cold Spring Harbor Laboratory, New York, in September, T2's Chief Scientific Officer Tom Lowery reported results for the T2Lyme panel, and said it detected Borrelia — the bacteria that causes Lyme disease — from patient samples at early stages of the disease with a limit of detection of less than 10 cells/mL.
At AMP this week, the firm said that a study involving patients diagnosed with Lyme disease at Gunderson Clinic in Wisconsin demonstrated that its technology detected Borrelia in samples from infected patients and that it may be able to detect Borrelia quicker than the use of antibody titers used in serological tests.
In a research note this week, Leerink research analyst Puneet Souda wrote that while the firm favorably viewed T2’s proprietary pathogen detection technology and large market opportunity, it was inclined to stay on the sidelines until T2 "delivers consistently on instrument placements and strings together a series of solid quarters in line with Street expectations."
Leerink expects that T2’s shares will gain strength if the diagnostics firm "meets or exceeds the updated timeline and expectations laid out for the T2Bacteria pivotal clinical trial in 1Q17 and approval in 2H17."