MedicalResearch.com: Why did you develop IsolateIBS-IBD?
Response: Isolate IBS-IBD arose from work started at Vanderbilt University, which found that autoimmune diseases exhibit distinct RNA patterns in blood and that these patterns often are specific for a particular disease. In our longitudinal and cross-sectional studies of many human conditions that span both autoimmune and non-autoimmune disease categories, we found that differences detected at the level of RNA can provide an accurate snapshot of a person’s disease. Using RNA, we can tell at a very early stage if a pattern exists that indicates a specific disease. With this information, providers can initiate treatment plans sooner and have an additional tool in their toolbox when making diagnostic determinations.
We developed this test because the symptoms of IBS and IBD are very similar, which can make it difficult and time-consuming for doctors to achieve an accurate diagnosis. IsolateIBS-IBD helps providers distinguish between the two conditions. It shouldn’t be viewed as a replacement or stand-alone test — doctors still need to use it in conjunction with clinical observation combined with traditional tests and procedures like a CT scan or endoscopic examination of the colon — but it can dramatically speed the diagnostic process. IQuity delivers results to providers within seven days of receiving the patient’s sample in the laboratory, allowing doctors to begin discussing a course of treatment as soon as possible.
MedicalResearch.com: How common are IBS and IBD?
Response: Irritable bowel syndrome (IBS) affects between 25 and 45 million people in the United States, about two-thirds of whom are women, according to AboutIBS.org. Worldwide, it’s estimated that between 10 and 15 percent of the population has IBS. The number of people with inflammatory bowel disease (IBD), which primarily includes Crohn’s and UC, is much smaller — around 3 million people in the United States, according to the CDC.
Both conditions are distinguished by moments of great gastrointestinal discomfort. But overall, IBS is much less serious than IBD, which can cause physical damage to the gut — chronic swelling, weight loss and even rectal bleeding. Crohn’s patients in particular are at risk of developing fistulas, abnormal connections made between different body parts, or bowel stenosis, a narrowing of the walls of the bowel that can cause painful obstructions.
MedicalResearch.com: How does the new test help distinguish IBS from IBD? Can you tell us more about the specifics of the test? Is it painful? Costly? How accurate is it?
Response: IsolateIBS-IBD uses RNA gene expression data to distinguish between IBS and IBD with a high degree of accuracy — higher than 90 percent. If a patient’s gene expression pattern looks like IBD, the test can identify if the patient’s RNA profile looks more like Crohn’s disease or ulcerative colitis (UC).
IsolateIBS-IBD is administered the same way as a typical blood test, so other than the slight discomfort of the needle, it’s a pain-free process. The sample is collected by a licensed technician and then shipped in a temperature-controlled package to IQuity’s CLIA-certified laboratory in Nashville, Tennessee. At the laboratory, IQuity’s technicians isolate RNA in the sample and measure it against a complex set of algorithms to yield a “yes” or “no” result that is more than 90 percent accurate.
MedicalResearch.com: What should readers take away from your report?
Response: With IsolateIBS-IBD, we want to help doctors arrive at an accurate diagnosis earlier, allowing them to start therapies sooner that can slow the progression of IBD, Crohn’s and colitis. The ultimate goal is to lessen the long-term damage from the disease and improve patients’ quality of life.
One barrier to early intervention that no test can overcome is that patients with gastrointestinal disorders often delay seeking a medical opinion because they are embarrassed about their symptoms. We need to work collectively to remove the stigma of these diseases by discussing them openly and educating patients about diagnosis and treatment options.
MedicalResearch.com: What other applications for RNA markers does IQuity have or is developing?
Response: We recently began taking orders from physicians for IsolateMS, the world’s first RNA-based blood test for multiple sclerosis. Like IsolateIBS-IBD, this test harnesses RNA gene expression data to identify the presence or absence of the disease with greater than 90 percent accuracy.
Because MS has traditionally taken months or years to diagnose from the onset of symptoms, we believe IsolateMS offers a powerful new tool that can speed up the diagnosis process while reducing rates of misdiagnosis that have been documented in the field. Clinician responses to IsolateMS have been very promising.
We are also working on IsolateFibromyalgia, a pioneering test that can identify fibromyalgia by analyzing RNA taken from a simple blood sample. Because opioids are frequently prescribed by doctors to manage fibromyalgia pain, we hope that this will have an impact on rates of opioid usage. We plan to release IsolateFibromyalgia later this year, following the release of IsolateIBS-IBD.
MedicalResearch.com: Is there anything else you would like to add?
Response: Autoimmune disease affects millions of people worldwide, and the rates only continue to rise with each passing year. When we do talks we ask people to stand and look to their right and then their left – one of those people will be suffering from one of the more than 80 autoimmune diseases and conditions plaguing the modern population. Our work helping providers achieve an accurate diagnosis at the earliest time point is crucial. Not only does this lead to getting patients on treatment sooner, but it also serves as a baseline for monitoring these patients, which helps to ensure therapies are effective, as well as helping doctors to identify and prevent or lessen periods of increased disease activity (relapses or flares). The data science that was foundational to IQuity’s development of diagnostic tests – which uses the latest RNA technologies – is itself emerging as a ripe area of investigation. As we look to the future, IQuity will leverage data science and machine learning to deliver new innovations in the healthcare field. 2018 will be an exciting time for the emergence of our new analytics business.
Pioneering test identifies IBS, Crohn’s or Colitis in a patient’s RNA profile, providing answers earlier than previously possible