Nashville-based specialty diagnostic technology company IQuity says it will begin taking orders from enrolled physicians for IsolateMS, reportedly the first RNA-based diagnostic test for multiple sclerosis (MS), in late May.
The product analyzes the expression of long noncoding RNAs (lncRNAs) to identify the presence or absence of MS with a high degree of accuracy. Test results are returned to providers in as few as seven days, according to the company. Current diagnostic processes that rely on clinical assessments combined with MRI and lumbar puncture (spinal tap) can take months or years as providers track the progress of irreversible neurological damage.
The IsolateMS test is ordered by a healthcare provider and can be administered at the earliest sign of symptoms. The test requires only a simple blood draw from the patient.
“Though it uses a blood sample, IQuity’s test is quite different than a conventional blood test,” said Chase Spurlock, Ph.D., CEO and co-founder of the company. “We isolate and measure the RNA found in the patient’s blood and then analyze their gene-expression data to make a determination of the presence or absence of disease using machine-learning technology.”
Blood samples are collected into a special tube called a PAXgene tube and transported to IQuity’s CLIA-certified laboratory in a temperature-controlled package to ensure sample integrity. Once the sample is received at IQuity, molecular technicians begin the testing process by isolating RNA.
The company plans to release two additional lncRNA-based diagnostic tests later this year. The first, in gastroenterology, will distinguish between irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD). The second test in the field of rheumatology and primary care will focus on the identification of fibromyalgia syndrome.