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Astute Medical Receives FDA Clearance for NephroCheck Test, Begins Prepping US Launch

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NEW YORK (GenomeWeb) – Astute Medical said this week that it has received US Food and Drug Administration 510(k) clearance for its NephroCheck Test System, a protein biomarker-based test for assessing risk of acute kidney injury.

The San Diego-based company said that it plans to launch US sales of the test in coming weeks through its strategic partner Ortho Clinical Diagnostics, the exclusive sales agent for Nephrocheck.

The test measures the presence of two proteins – insulin-like growth-factor binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases (TIMP-2) – in urine, allowing clinicians to assess in about 20 minutes the risk of a patient developing AKI in the next 12 hours. According to Paul McPherson, the company's chief scientific officer, the test is able to identify patients who go on to develop AKI with an accuracy of around 90 percent.

According to numbers from Astute, of the more than 5 million critically ill patients accepted into US hospital intensive care units each year, roughly half will develop AKI. The condition is associated with significantly increased hospital stays and readmission rates as well as increased costs and worse patient outcomes.

Prior to this week's NephroCheck clearance, there were no FDA-cleared biomarkers for AKI on the market, noted Kianoush Kashani, a nephrologist at the Mayo Clinic. Kashani is not an Astute employee but was involved in collecting patient cohorts for the company's biomarker development studies.

"There is significant research data on a few biomarkers, but none of them are clinically approved," he told ProteoMonitor. Additionally, he said, most of the biomarkers that have been studied as possible markers for predicting AKI have suffered from a lack of specificity – an unsurprising problem given that AKI patients tend to exhibit a number of other conditions.

Specificity, Kashani noted, is the key advantage of the NephroCheck test. While other markers are often elevated in cases of chronic kidney disease or other syndromes common in ICU patients, the NephroCheck markers "tend to be very specific for AKI," he said. He added that he plans to begin using the markers with his patients now that they have received FDA clearance.

Kashani also noted the markers' potential usefulness for research into treatments for AKI. Upon identifying patients with AKI or who are likely to develop the condition, clinicians follow various procedures such as avoiding nephrotoxic medications and increasing monitoring. However, there are no specific therapies for AKI.

One challenge to developing therapies for AKI has been being able to identify the condition early enough to intervene successfully, he said, noting that the NephroCheck markers could potentially help with this issue.

This week's clearance follows an EU CE mark Astute received for the test in 2012. The company launched European sales of the test that year, though CEO Christopher Hibberd declined this week to provide any numbers on sales of the test in Europe.

Astute last month entered into a sales and licensing agreement with OCD under which Astute made the company the exclusive sales agent for NephroCheck and the Astute 140 Meter device on which the test is performed in the EU and US. Additionally, OCD made a $15 million equity investment in Astute.

The decision to partner with a larger company on commercialization of NephroCheck runs somewhat counter to recent trends in the proteomic diagnostics space where some companies with recent launches like Integrated Diagnostics have elected to handle all sales and marketing efforts in-house and other companies like Vermillion have worked to retake control of sales and marketing after unsatisfactory experiences outsourcing these efforts to larger firms.

Indeed, taking over from Quest Diagnostics commercialization efforts for its OVA1 ovarian cancer test has emerged as the cornerstone of Vermillion's new strategic relaunch. The company has asserted that Quest sales representatives were not sufficiently focused on driving OVA1 sales and that they had little visibility into OVA1 sales patterns, which hampered their own internal commercialization efforts.

Hibberd acknowledged such concerns, but, he said, OCD is fully committed to commercialization of Nephrocheck. He also noted that while OCD is the exclusive sales agent for the test in the US and Europe, Astute is also developing a substantial in-house sales staff that will lead and guide the commercialization effort.

"We haven't just handed it over to [OCD] and asked very busy reps who are selling many things to suddenly be knowledgeable about this area," he told ProteoMonitor. "We are hiring a specialized sales force who will work in parallel with them. So you have the disease expertise concentrated in a few [Astute reps], and then they have a much broader reach with the field force of [OCD]. So we think that is a really great formula."

Hibberd said Astute plans to hire around 25 sales and marketing personnel in the next few months, which will bring the company's headcount to around 75.

In addition to taking advantage of OCD's sales force, Astute also hopes down the line to take advantage of the company's Vitros automated testing platform, Hibberd said, noting that the companies are working to develop an automated version of the test for that platform that could in the future be useful for facilities running high volumes of the test. Currently the test is run on Astute's Astute140 Meter, a manual immunoassay device.

"If you look at it from a market development strategy, you can get pretty good penetration on a small platform, but over time as a test becomes routine customers are going to want an automated solution," Hibberd said. "So what we would like to do is give customers a choice and have an automated solution like the [OCD] Vitros platform. That will address one of the needs that we see down the road."

Noting that an automated test would need its own FDA 510(k) clearance, he said that such a version was likely a few years off.

In the meantime, Astute continues to work on additional protein biomarker tests, with the goal being to launch one additional test each year, McPherson told ProteoMonitor. The company plans next year to release a new test also focused on kidney injury.

It also has research programs in acute coronary syndromes, abdominal pain, cerebrovascular injury, and sepsis.