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ImmunArray Continues Lupus Rule-Out Assay Rollout, Eyes Longitudinal Testing

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NEW YORK (GenomeWeb) – As microarray-based diagnostics firm ImmunArray grows its test to rule out systemic lupus erythematosus (SLE), it's investing in studies to justify longitudinal testing for lupus and other immune system-related conditions.

ImmunArray, based in Rehovot, Israel and Richmond, Virginia, performing commercial testing of its SLE-Key test to rule out SLE, even receiving reimbursement under the Multianalyte Assays with Algorithmic Analyses (MAAA) code. The microarray-based test uses a multiplex panel of biomarkers — including protein antigens and oligonucleotides — and algorithmic analysis to provide clinically actionable information.

With one test already on the market, the firm has turned its research and development efforts towards a test to monitor disease activity of SLE.

Currently, the disease is monitored using an index that's based on both subjective and objective measures, ImmunArray President and CMO Scott Batty told GenomeWeb. "Depending on how well or poorly you feel on any day, your score may fluctuate. It's an inexact tool, but it's all [doctors] have right now," he said.

ImmunArray believes it can use its platform to develop a blood-draw test that it can correlate to fluctuations in disease activity. It's currently in the process of collecting samples for a study that will put this thesis to the test.

That's the latest development for a company which also has R&D projects to evaluate traumatic brain injury and how the immune signature in that condition changes over time.

By adding a time dimension to the equation, the company could increase the volume of tests it runs at its specialized lab. "Instead of a single test to sell at the time of diagnosis, you now have a test to run two to four times a year in perpetuity," Batty said.

Building up SLE-Key

ImmunArray is still focused on expanding the use of SLE-Key, having just received a $10 million private investment in order to improve manufacturing, as well as fund R&D in other immune-related diseases. CEO Donna Edmonds said the firm has performed more than 500 tests to date, and is receiving enough volume to run it three days a week. "We're growing," she said. "Our [second quarter of 2016] increase over Q1 was significant."

Turnaround time is between three to five days, Batty said, "but as volume and demand builds we'll push that down."

Edmonds highlighted that the test is being billed under the MAAA code, which went into effect on Jan. 1.

"We are getting paid directly by the insurers and our average reimbursement is very close to our list price," Edmonds said. While she declined to disclose the list price, she said its "in four digits and it's in the neighborhood of other complex tests," which run between $1,000 and $3,300. SLE-Key is on the lower end of that range, she said. "We're a microarray test with a lot of information and a lot of clinical value," she said. "We have been able to receive price and reimbursement commensurate with that value."

The firm is also negotiating in-network pricing with payers in the US, she said, as well as building a US sales and marketing team across the country. Outside the US, the firm is pursuing ISO certification and CE marking for the rule-out test.

Disease activity monitoring

Building off SLE-Key is an idea that makes not only business sense, but clinical sense, Batty and Edmonds said. The idea for a lupus disease activity monitoring test came from the firm's advisory board, following the launch of SLE-Key, and is analogous to Crescendo Bioscience's Vectra DA test for rheumatoid arthritis.

The goal is to create a more reliable yardstick with which to monitor disease activity, Batty said. Instead of waiting months to find out that a patient isn't responding to therapy, doctors could immediately monitor that response, or lack thereof.

But in order to develop such a test, ImmunArray will need to show it can correlate biomarkers to disease activity, requiring a series of samples collected over time, with correlated clinical data that can show the episodic nature of the disease. The firm is currently in the process of obtaining those samples and accompanying data.

ImmunArray hopes to finalize the study soon and use the same study methodology it used to develop SLE-Key. Batty said the study could launch as early as next year.

Once the samples are collected, ImmunArray researchers will look for panels of biomarkers that correlate with disease activity. The chip design for the study has already been decided on, Edmonds said. "We would start off with some of the antigens used in the first product," Batty said. "Because it's looking at disease processes in action, we're including some others. Whereas before we maybe had a few representatives of acute inflammation markers, we may have more depth and breadth across that class, because it's an active inflammatory process."

Edmonds noted that should the company put together a viable biomarker panel for lupus monitoring, the test would likely be offered at a lower price than SLE-Key, to account for the fact the test would be run multiple times.

Head Examinations

Meantime, the firm is continuing its research on traumatic brain injury. ImmunArray was one of the GE and National Football League Head Health Challenge grant recipients and has used additional funds from an industrial research partner to launch another 500-patient trial, with authorization to enroll up to 600.

"It has provided a robust sample set on which we can do an awful lot of analysis," Edmonds said. "We've just formalized the final design of what will be our third-generation brain injury chip that we're doing research with. It's very clear that the immune system kicks in post-injury." Moreover, she said ImmunArray's testing can show if trauma leads to a chronic injury: higher levels of inflammatory proteins, representative of many chronic disease processes, as well as brain-specific proteins. "If it doesn't resolve itself, you can detect the effects of brain injury at one, three, or even six months," she said. "As it becomes more chronic, it's very clear you can detect it. You can underline 'very.'"

So far, ImmunArray has several candidate panels for different patient presentations and different time points following injury. In a statement released earlier this week, the firm said that some panels can detect TBI patients with 95 percent specificity and at 95 percent sensitivity.

According to Edmonds, no one biomarker or time point following brain injury can successfully detect it. To her, it's validation of the multiplex platform her company offers and the longitudinal studies they've invested in.

"We think there are probably four or five different panels that will be used at different time points," to detect TBI she said. "It's about how the biology changes. You can't do it with one biomarker, but it's consistently evident to us it's this multiplex combo which provides the real specificity," she said.

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