Sepsis, a blood borne infection that results in severe inflammation, is not to be trifled with.
"Sepsis is the sixth most common reason for hospitalization and typically requires double the average length of stay," according to Congressional testimony provided by a senior official with the Centers for Medicare and Medicaid, in September 2013.
"It complicates four out of 100 general surgery cases, has a 30-day mortality rate of 1 in 20, and leads to complications such as renal failure and cognitive decline," explained Patrick Conway, chief medical officer and director, Office of Clinical Standards and Quality, CMS, to Congress.
Part of the problem stems from the fact that there is no quick way to diagnose the condition and specifically the type of sepsis that a patient may have. A blood culture to confirm the diagnosis and identify the species causing sepsis can take anywhere from two to six days.
|John McDonough, president & CEO, T2Biosystems|
That is where a Massachusetts company is aiming to be a game changer. The company has developed an FDA-cleared test that can positive identify sepsis and determine whether it's bacterial or fungal within three to six hours, explained John McDonough, president & CEO, T2Biosystems.
Given the government's and hospitals' current focus on reducing hospital-acquired infections, T2Biosystems has great potential for success if it can convince hospitals to adopt its tools.
"The good news with sepsis is that there are good drugs available," McDonough said in a recent interview. "The problem is there are over a 100 drugs available to treat patients, so you need to know the specific species of the infection to target that treatment."
That is where the company's T2Candida test and T2Dx instruments come in. FDA cleared the them in September to detect Candida, a dangerous and lethal form of blood stream infections that causes sepsis. The company states that T2Candida and T2Dx are the first diagnostic products based on a magnetic resonance-based diagnostic technology platform that does not require blood culture and sample purification or preparation.
"FDA cleared [the tests] in less than four months, which the FDA told us was a record for them. What drove that clearance was that FDA absolutely understood the interest of public health in getting this product to market. And the fact that we had run our test in over 1,800 patients and had demonstrated outstanding performance," McDonough said.
In fact, a recent article in the journal Clinical Infections Diseases showed that T2Candida panel and instrument demonstrated 91.1% sensitivity and 99.4% specificity for sepsis.
Further, the tests were found to be able to detect sepsis where blood culture had returned negative results.
"There were 11 cases cited in the article where we demonstrated that we were right when blood culture had missed," McDonough said.
Another benefit of the test is that it requires much less blood than a regular blood culture.
"In blood culture you are typically using 20 mls of blood," he said. "In our case, we need only 3 to 4 ml."