A fast test to determine if an infection is viral or bacterial or whether a patient may progress to a more severe condition such as sepsis, has been approved by the FDA.
The test was developed by California-based Inflammatix. Known as TriVerity, it is a benchtop machine that uses a cartridge-based system to test patient samples.
It is able to measure the expression of 29 genes that regulate a person’s response to infection and assess if they have a high likelihood of having a bacterial or viral infection within around 30 minutes.
The test is also able to indicate how sick a patient is likely to become over the week following the test. For example, if they have a condition such as sepsis and may need to be admitted to intensive care and/or be mechanically ventilated, receive vasopressors or treatments such as renal replacement therapy.
Sepsis occurs when the body essentially overreacts to infection with bacteria, viruses or even fungi in some cases. Excessive inflammation occurs and then results in a range of symptoms including fever, high heart rate, fast breathing, and confusion, among others. If not picked up quickly enough sepsis can lead to organ failure and low blood flow and eventually death.
Due to the range of symptoms that can be expressed in people with sepsis and the fact that it occurs after an initial infection it is thought to be underreported but estimates suggest it occurs in up to 2% of all hospitalizations. Around 25% of intensive care unit beds are taken up by patients with sepsis.
Fast diagnosis can dramatically improve outcomes for people with sepsis so the quest to develop accurate and fast tests is ongoing.
“Despite billions of dollars’ worth of innovation and decades of work, sepsis mortality remains frustratingly high, and sepsis remains the most expensive diagnosis to the healthcare system,” said Tim Sweeney, MD, PhD, CEO and co-founder of Inflammatix, in a press statement.
“The fundamental problem with existing tests is an outdated focus on labeling patients as ‘septic or not.’ But sepsis is a syndrome, not a disease, and its definition keeps changing. We therefore 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 TriVerity test is designed to act a bit like a triage system to quickly direct clinicians towards the best treatment pathway for each patient. By not specifically labelling patients as having sepsis it can also be used to ensure that people with severe infections that cause other health problems such as pneumonia or cellulitis are also identified.
The FDA clearance is based on a study including 1222 patients, which showed the test was able to predict the three outcomes with a high level of accuracy with area under the receiver operator curve scores ranging from 0.77-0.91.
Inflammatix also has other precision tests in its pipeline including a test to assess how a patient will respond to sepsis therapy and a fingerstick test to assess if patients in a primary care setting have bacterial, viral or no infection.
