NEW YORK (GenomeWeb) – After facing delays to commercialize its product as an in vitro diagnostic, life sciences firm InDevr aims to launch a research-use-only (RUO) version of its FluChip-8G Influenza A+B assay this year to help enhance influenza surveillance and pandemic preparation.
In the meantime, the firm is still pursuing US Food and Drug Administration Clearance, which it hopes to receive by 2019, and also plans to expand its resources to animal influenza surveillance.
Founded in 2003 at the University of Colorado, Boulder, InDevr has spent the last decade developing and improving its flu testing technology, which detects nearly 500 genetic segments in the viral genome.
Initially funded by the National Institutes of Health, InDevR received a federal contract from Biomedical Advanced Research and Development Authority (BARDA) in 2014, worth up to $14.7 million, to continue developing the diagnostic test and see it through the FDA clearance process.
InDevr's 8G Influenza A+B assay simultaneously amplifies eight critical gene segments — including HA, NA, and M — followed by hybridization, in which capture sequences printed on a microarray detect and snag hundreds of multiple amplified gene segments.
After hybridization and sample washing, the microarray is fluorescently imaged and the results analyzed using an algorithm that identifies specific influenza species. InDevr CEO Kathy Rowlen explained that the entire test only requires a few minutes, after initial nucleic extraction from a sample, and is simple enough to use that it can be run in any lab that typically performs PCR testing.
Within the microarray, the bright green dots in the hybridized sample "act like fingerprint recognition," and represent the intensity of a part of the viral genome bounded to the microarray. InDevr's assay then displays the results retained for each sample analyzed via a PDF report for the end user. According to Rowlen, the RUO model of the FluChip platform rapidly identifies all seasonal strains, as well as multiple non-seasonal strains, such as A/H5N1.
Rowlen emphasized that FluChip will provide more information than current testing options with less required expertise. Since users do not need a bioinformatics expert to analyze the data for each run, InDevr can focus on placing the test in resource-limited settings to serve as frontline sentinels for new and emerging influenza viruses.
"High-throughput sequencing and whole genome sequencing has come along so fast and far, but there is currently a bottleneck because you need a bioinformatics expert to curate and interpret the data," Rowlen elaborated. "The data interpretation is as difficult if not harder as the assay for sequencing the data."
The firm therefore aims expand into foreign markets and is negotiating with potential early adopters and partners in Southeast Asia. Rowlen explained that "there is currently so little influenza surveillance performed [in those regions], and we want to have such a big impact" and act an early warning system for new flu viruses.
InDevr also sees larger market potential in the food industry by using the test for animal influenza surveillance. In this type of application, InDevr's platform would serve as a tool to detect novel strains of avian and swine flu, Rowlen said.
With the current contract from BARDA, InDevr also aims to develop a microfluidic cartridge for FluChip, or a sample-to-result system that Rowlen said will "be about the size of standard HP calculators" and will potentially allow InDevr to reach even more limited-resource areas.
Longer term, InDevr plans for major growth over the next couple years because of FluChip 8G and VaxArray, an assay that tracks seasonal and pandemic hemagglutinin potency in finished vaccines. Rowlen envisions double-digit growth due to both products.
In the meantime InDevr is finishing up a clinical study with 1,500 patient samples and plans to submit clinical results to the FDA within the next few months. While Rowlen declined to comment on the accuracy of the FluChip platform, she anticipates clinical specificity and sensitivity to be competitive with other types of influenza detection tests.