DxTerity Test to Guide SLE Therapy Now Available in All 50 US States

Blood test measures the activity of four IFN-1-related genes

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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DxTerity Diagnostics’ interferon-1 gene signature test, which can be used to help guide treatment decisions for people with systemic lupus erythematosus (SLE), is now available for use in all 50 U.S. states, the company has announced.

“It is our mission to transform patient care with precision diagnostic tools that support a personalized approach to the treatment, and we can now provide our testing service to patients all across the US,” Bob Terbrueggen, PhD, founder and CEO of DxTerity, said in a press release.

The diagnostic test most recently received authorization in New York State.

“We are excited to expand availability of DxTerity’s IFN-1 gene signature test to New York State,” Terbrueggen said. “The New York Clinical Laboratory Evaluation Program is the most stringent in the country and I am proud of our team’s ability to meet these stringent requirements.”

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SLE, the most common form of lupus, is caused by the immune system mistakenly launching an inflammatory attack that damages the body’s own healthy tissue. It’s estimated to affect up to one million people in the U.S.

Type 1 interferons, or IFN-1, are signaling molecules that act as powerful drivers of inflammation. When immune cells sense an infection, they release IFN-1 to sound the alarm, activating other cells and biological machinery to fight off the invader. However, abnormal IFN-1 activity can also contribute to the autoimmune attack that drives lupus.

DxTerity’s test is designed to determine whether a person with SLE has high or low IFN-1 activity. The test, done on a blood sample, specifically measures the activity of four IFN-1-related genes.

More than half of SLE patients have high IFN-1 activity (also referred to as “always on IFN-1” or “being IFN-1 high”), according to the company. These patients tend to have more severe disease symptoms, and they are at an increased risk of developing lupus nephritis — a form of lupus-related kidney inflammation that can be severe.

IFN-1-high patients are also less likely to respond to standard SLE treatments, according to DxTerity. But these patients may be good candidates for medications that specifically target the IFN-1 pathway. These include, for example, Saphnelo (anifrolumab-fnia), a therapy developed by AstraZeneca that was approved to treat patients with moderate to severe SLE in the U.S. last year.