NEW YORK (GenomeWeb) – By the end of 2016, InDevr aims to have a microarray-based clinical test on the market for genotyping influenza viruses.
The Boulder, Colo.-based company recently received a federal contract worth up to $14.7 million to develop the assay, called FluChip-8G, with the goal of supporting the test through US Food and Drug Administration clearance.
Should the company achieve FDA clearance for the test, it will be competing with a bevy of rivals, such as Waltham, Mass.-based Alere, which in June garnered regulatory clearance for a PCR-based influenza test that can both detect and discriminate between the nucleic acids of influenza A and influenza B viruses.
However, InDevr believes that FluChip-8G will be superior to available in vitro diagnostics for influenza in terms of the amount of information it delivers.
"While some FDA-cleared influenza diagnostic tests indicate virus type, some indicate type and subtype, and others can be performed separately to determine susceptibility to antiviral resistance, FluChip-8G provides all of that information and more within a single test," InDevr CEO Kathy Rowlen said in an email this week.
"Our long-term objective is for FluChip-8G to become the new standard of care for influenza diagnosis," Rowlen said.
Rowlen co-founded InDevr in 2003, and the firm's activities have expanded over the past decade to include the launch of a colorimetric detection platform called AmpliPhox, Miplex custom arrays, and a fluorescence-based imaging system called Vidia.
But the company's main thrust has been in the area of pathogen detection, including the development of several arrays for influenza typing, as well as the establishment in 2012 of a new company called ViroCyt to commercialize InDevr's Virus Counter platform for virus quantification.
In July, InDevr launched Influenza Titer on Chip, or Flu-ToC, a multiplexed immunoassay for rapidly quantifying seasonal influenza hemagglutinin protein that is used by vaccine producers to characterize flu vaccine potency.
Rowlen distinguished FluChip-8G as a "highly multiplexed in vitro molecular diagnostic" for influenza viruses, adding that it provides "significantly more genotype information about influenza viruses detected in clinical samples" than previous versions developed by the company
InDevr's 8G assay is based on the simultaneous amplification of eight genes followed by hybridization to a microarray with sequence-specific targets, automated image analysis, and automated results interpretation by a digital neural network.
InDevr said that in an early pre-clinical assessment of the assay, the chip accurately identified virus type and subtype, including lineage and antiviral susceptibility. The assay is also designed to differentiate between species of origin, geographic region of origin, and pathogenicity, the company said.
Should it achieve FDA clearance, InDevr's FluChip-8G will enhance clinical diagnosis of influenza in hospitals, urgent care facilities, and clinical laboratories by "enabling physicians to distinguish between seasonal strains and potential pandemic non-seasonal strains of the influenza virus, such as H5N1 or H7N9," the company said.
InDevr initially supported the development of 8G with a $3 million grant from the National Institute of Allergy and Infectious Diseases. Last week it announced a new contract with the Biomedical Advanced Research and Development Authority to see its array through the FDA clearance process.
BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the US Department of Health and Human Services. Part of the office's mission is to support the development of new tests for influenza viruses.
According to Rowlen, the base period of the contract is for two years and has a funding commitment of $7.9 million. Should the company meet certain milestones, that funding will nearly double to $14.7 million. Milestones for the base period include meeting performance specifications in pre-clinical testing, filing for an investigational device exemption, conducting clinical studies, and, if appropriate, submitting a 510(k) application to the FDA, Rowlen said.
"If all goes well, there are two option periods," she added, "the main focus of which is development and validation of a fully automated, cartridge-based, sample-to-result platform to perform the assay."
In addition to the BARDA funding, InDevR is investing its own resources into this project, primarily through infrastructure support, Rowlen noted. As an example, she said that the company is working to make its facility and processes compliant with Code of Federal Regulations and International Organization for Standardization guidelines for medical device manufacturing, 21 CFR 820 and ISO 13485, respectively.
Another potential bonus for InDevr related to the BARDA contract is the authority's familiarity with federal regulations.
"BARDA has an accomplished and knowledgeable staff," said Rowlen. "As we are new to the FDA submission process, we will undoubtedly benefit from their accumulated experience."