Bolstered by a recent $10 million financing round and a 19-country distribution pact, Irvine, Calif.-based biotech firm Aviir is pushing its MIRISK VP protein biomarker test into the increasingly crowded cardiac risk assessment market.
According to CEO Douglas Harrington, the company has begun the first phase of its broad commercial launch of the test, offering it in select US regions as a laboratory-developed test out of its CLIA facility. He added that Aviir has contracts for the test with five preferred provider organizations, covering roughly 80 million lives, and that it plans to apply for Medicare coverage in the second half of this year.
Prior to the recent launch, Aviir was offering the test in Orange County as part of a small-scale pilot sales program.
MIRISK VP measures levels of seven proteins linked to the development of vulnerable arterial plaque to predict an individual's risk of suffering a cardiac event within the next five years. The test originated from research performed at Stanford University. Aviir was founded in 2005 to further develop and commercialize this research.
The test is intended to supplement traditional risk measures like family history and cholesterol levels with the aim of identifying high- and low-risk individuals within the population deemed intermediate risk by such conventional assessments. It is meant for use in such intermediate risk patients 40 years and older, a population of between 20 million and 30 million people in the US, Harrington told ProteoMonitor.
To order MIRISK VP, patients must be identified by their physicians as intermediate risk either via conventional risk scores like the Framingham Risk Score or via the company's own MIRISK test, an assessment that uses age, gender, diabetic and smoking status, HDL, total cholesterol, and blood pressure.
Explaining the rationale for focusing on these patients, Harrington estimated that 40 percent of all cardiac events come out of that intermediate risk group. "The goal was to look at that middle intermediate risk group where there is a lot of uncertainty and no treatment guidelines and upclassify high-risk individuals who were being missed and downclassify low-risk individuals who would not benefit from more intensive treatments," he said.
In a 5,000-plus patient validation study published in the November issue of Current Medical Research and Opinion, the test achieved a 43 percent net reclassification index in subjects identified as intermediate risk by the Framingham Risk Score, the gold standard for measuring cardiac risk. It identified roughly 17 percent of low- and 26 percent of high-risk patients initially classified by the FRS as intermediate risk.
The test's seven biomarkers are proteins linked to development of vulnerable plaque, which can rupture and cause a heart attack.
"A common misconception is that the most common cause of heart attacks is a narrowing of the arteries," Harrington said. "In fact, more than 70 percent of heart attacks are caused by plaque rupture. So it's a significant problem, and it's been very difficult to identify these individuals at an early enough stage to take preventative measures" such as making lifestyle changes or going on medications like statins.
He noted that this has been a particular problem with women, whose cardiac risk has been more difficult to predict via traditional means like cholesterol and lipid levels.
MIRISK VP's markers emerged out of messenger RNA-based studies investigating pathways involved in development of vulnerable plaque. From this work, the researchers identified 250 potential protein markers, which they then winnowed down to 42 possible markers via a series of stacked ranking univariate studies.
They then ran these 42 proteins in a study of 20,000 patients with roughly 10 years of follow-up, using a trio of modeling methods to identify the most powerful markers. In each of the three models, the same seven proteins emerged as the most powerful predictors of a cardiac event, Harrington said.
Last week, Aviir announced an agreement with Partners & Partners to distribute the test in 19 Middle Eastern and North African countries. Earlier this month, it closed a $10 million funding round led by Merck Global Health Innovation Fund and including investment from P&P, Bay City Capital, Aberdare Ventures, and New Leaf Venture Partners. With the close, the company has secured $20 million of a possible $30 million in financing, with the final $10 million contingent on hitting certain commercial metrics.
As it begins ramping up its sales efforts, Aviir will continue to expand its national presence by building out its specialty sales force throughout 2013, Harrington said
Cardiac risk is a significant area of interest in protein biomarker development, with several firms beyond Aviir pursuing such tests. For instance, FirstMark, a division of Genway Biotech, offers its PREvent test, which similarly measures heart attack risk based on protein biomarkers for vulnerable plaque formation. That test consists of three protein markers – hsCRP, HSP70 and FDP – and is intended to predict risk within a two- to three-year window, as opposed to MIRISK VP's five-year window.
BG Medicine's CardioScore test is also aimed at detecting patients at risk from vulnerable plaque, predicting risk over a two- to four-year window. In February 2012, the company presented data from the 6,600-patient BioImage Study – an effort undertaken as part of the High-Risk Plaque Initiative founded in 2007 by BG, Merck, AstraZeneca, Philips, Takeda, and Abbott to study heart attack and stroke – that found that when combined with the FRS, CardioScore identified at baseline 54 percent of patients who would experience a major cardiovascular event within two years (PM 2/17/2012).
The company received an EU CE mark for the test in December. However, in August it withdrew its submission to the US Food and Drug Administration seeking 510(k) clearance for the test, saying it would not be able to respond in full to a request from FDA to confirm certain data from the company's validation study for the test (PM 8/10/2012).
BG remains in discussions with FDA about the test. However, during a quarterly earnings call in November, president and CEO Eric Bouvier suggested that, given the delay in its FDA submission, BG might launch CardioScore in the US as a lab-developed test through its planned CLIA lab. The company plans to open the lab in the first half of 2013 and aims to launch sales of CardioScore around the same time. It is also targeting a mid-2013 launch for the test in Europe (PM 11/16/2012).
According to Harrington, Aviir has no immediate plans to take MIRISK VP through FDA, but views it as a potential opportunity down the road. He noted that because the test is performed via immunoassay, it could be configured for a variety of different platforms currently in clinical use.
In addition to its proteomic work, Aviir also has programs in genomics and plans next month to roll out next-generation sequencing-based assays for investigating congenital cardiac pathologies like long QT syndrome, Harrington said.
The company is also working on genomic tests to predict the effectiveness of particular statins for a given patient.