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Following $2M Seed Financing, IQuity Aims to Launch First LDT in 2016

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NEW YORK (GenomeWeb) – After securing $2 million in seed funding in January, molecular diagnostics startup IQuity Labs is nearing the launch of its first product, a blood-based test to diagnose multiple sclerosis (MS) at the onset of symptoms, with additional tests in gastroenterology and rheumatology expected to follow over the following 12 months.

While its current lineup of diagnostics rely on analyzing gene expression patterns detected in messenger RNA via PCR, the Nashville, Tennessee-based company is also in the early stages of testing the diagnostic potential of long, non-coding RNAs (lncRNA) with the support of grant funding from the National Institutes of Health.

IQuity was founded by Vanderbilt University's Thomas Aune and Chase Spurlock, who now serves as the company's CEO, to develop commercial diagnostics based on discoveries made in Aune's lab around gene expression and human disease.

The most advanced of these efforts is in MS, and Aune has published a number of papers describing the identification and diagnostic application of mRNAs as biomarkers for the disease. Most recently, in 2013, he and colleagues reported in the Journal of Clinical Bioinformatics how a panel of 30 genes, selected through microarray and whole-genome RNA-seq analyses, could be used to predict which individuals with clinically isolated syndrome (CIS)— a neurologic episode characterized by symptoms caused by inflammation or demyelination of the central nervous system — would go on to develop MS from a single blood sample. 

Based on these and related data, IQuity is now preparing to launch by mid-year the IQ Isolate Multiple Sclerosis test, which the company aims to position as a companion laboratory-developed test (LDT) to MRI for the diagnosis of MS. 

For the test, whole-blood samples are collected in PAXgene tubes, and total RNA is then purified, reverse transcribed, and analyzed using PCR-based arrays. "Whole-genome sequencing is still pretty expensive, and turnaround time on a next-generation sequencing experiment can be pretty lengthy," Spurlock told GenomeWeb this week. "PCR is really the gold standard for measuring gene activity." 

The resulting data are then interpreted using IQuity's proprietary algorithms and technology. 

"Our test is complementary to existing diagnostic strategies," Spurlock said. "MRI for MS is still the gold standard and we're not disputing that. … [But] we think it would be great to have a tool for the [healthcare] provider … to say, 'What does the molecular portrait look like in this [patient's] blood sample? Is it consistent with a gene expression pattern of MS or not?'"

IQ Isolate Multiple Sclerosis, he added, "gives a provider another cue … to get to a diagnosis sooner and then promote a better quality of life for the patient by giving them access to therapies that can help them that day. Earlier access to treatment leads to the best long-term outcomes."

Notably, IQuity is not aiming to process test samples itself, but intends to have the gene expression analysis performed by partner labs. "We provide the analytics [around] the gene expression values that are generated … and construct a molecular portrait for an individual patient," Spurlock explained.

IQuity has already formed one such alliance, signing a deal in February under which its MS test will be made available through Diatherix, and inking similar agreements is a key aspect of the company's overall commercialization strategy for its tests.

Beyond MS, IQuity is also developing an LDT for identifying irritable bowel syndrome (IBS) versus inflammatory bowel disease (IBD), and then further classifying IBD as either Crohn's disease or ulcerative colitis.

Data around this test has also been published in the literature, including a 2012 JCB study in which transcript levels of 45 genes in blood samples were able to discriminate irritable bowel syndrome from control, inflammatory bowel disease from control, irritable bowel syndrome from inflammatory bowel disease, and ulcerative colitis from Crohn’s with high sensitivity and specificity.

The company also has a similar test in the works for identifying fibromyalgia from rheumatoid arthritis (RA) or lupus.

"You have to exclude a diagnosis of RA and lupus to get to a diagnosis of fibromyalgia," Spurlock explained. "What we're coming to appreciate is that fibromyalgia is a condition that is discreet and discreet among the other rheumatic diseases," particularly at the level of gene expression.

Both these tests are expected to launch by mid-2017.

Once its tests are introduced, IQuity hopes to be able to gather data around their performance against the current diagnostic gold standards and "how they integrate into clinical practice," Spurlock said. "We imagine several longitudinal studies to assess the performance, [which] would be crucial in any conversation with the FDA" about getting formal approval for the tests. 

Although it is focused on the these upcoming product launches, IQuity is also exploring an earlier-stage opportunity in lncRNAs in collaboration with Aune's Vanderbilt lab. Last month, the company received a one-year NIH grant worth $159,825 to identify lncRNAs that are differentially expressed in MS and assess their potential as biomarkers. 

"The long, non-coding RNA signatures we see in [preliminary studies] are quite remarkable," Spurlock said, adding that he envisions lncRNAs as someday being used in conjunction with other biomarkers to diagnose MS and other conditions.

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