InDevR, a biotech firm founded in 2003 by researchers at the University of Colorado, Boulder, has licensed from the university an array-based diagnostic chip for identifying various strains of the flu virus, including the swine H1N1 virus, the company said last week.
For CU, the deal represents a second chance to bring the technology, called FluChip, to market, as the technology's previous licensee, San Diego-based diagnostic company Quidel, terminated its license with the university late last year for unknown reasons.
"Quidel licensed the technology for close to two years, and then they terminated it. We didn't really get from them the details of exactly why," Mary Tapolsky, senior licensing associate in CU's Technology Transfer Office, told BTW last week. Calls to Quidel seeking comment were not returned.
The new licensing agreement is also a second chance of sorts for InDevR to bring FluChip – which CEO Rowlen co-developed during her previous tenure as a part-time professor at CU and part-time CSO of InDevR – back into its technology mix.
When FluChip was available for licensing in 2006, InDevR was not able to license it from CU "because it was too costly at that time," Rowlen told BTW. "We had like one employee. I would have loved to have kept it in house, but it was beyond our means."
CU, believing the technology had promise for diagnosing various strains of the influenza virus, wanted to see the technology further developed, and chose Quidel as a partner.
"Our view at the beginning was that Quidel is a leader in discovering, developing, and manufacturing rapid diagnostic solutions for infectious diseases and reproductive health," CU's Tapolsky said. "They were interested in this technology, and just seemed like a good partner to develop this IP."
InDevR, meantime, "had a lot of other things on its plate, and they never asked us for a term sheet," Tapolsky said. "It's not like we were negotiating with both companies."
Once Quidel terminated its license with CU, Rowlen, who since had left the university to work full-time with InDevR, stepped in. "Obviously as an inventor on this technology, she was aware of the termination of the license," Tapolsky said. "And she said that InDeVer is now at a place where it has the bandwidth to move this forward."
Rowlen agreed that "CU was interested in seeing this technology come to fruition as a product, and they gave us some terms that were amenable to a small company to operate." Asked whether the university had changed its asking price for licensing the technology since 2006, Rowlen replied that FluChip is now "no longer beyond our means."
Terms of the licensing deal were not disclosed, although Tapolsky said that it was a "standard" agreement with an up-front payment and milestones and royalties attached.
Use In Case of Emergency
Rowlen and colleagues at CU developed FluChip using a $2 million, five-year grant from the National Institute of Infectious Diseases. The technology is a microarray in which each spot contains a DNA segment from a different flu strain. RNA fragments from an infected sample are incubated with the chip, and binding events can be detected using either microscopy or an array scanner.
In fact, InDevR said it will combine FluChip with its proprietary detection technology – which it previously licensed from CU – to reduce the cost of the diagnostic test and make it easy to use in any lab with basic PCR capabilities. The detection technology is based on a technique called non-enzymatic signal amplification, which uses photopolymerization of an organic monomer as opposed to a fluorophore tag, like many microarrays. Resulting signals can be detected with the naked eye or with an inexpensive laser scanner, according to the company.
In addition, according to Rowlen, a version of FluChip called "M-gene," which she and her colleagues at CU worked on previously, appears to be able to distinguish human H1N1 flu viruses from the new swine H1N1 strain that is at the center of the recent worldwide outbreak.
Because of the relative maturity of the technology, Rowlen said that InDevR hopes to be able to deploy the FluChip test as soon as possible to capitalize on the current and potential future market for swine flu testing – a market that is rapidly crowding, as several companies have disclosed that they are developing diagnostic tests based on a number of technology platforms to identify the swine strain.
"Under the public emergency situation that we're in right now, [public health labs] can use investigational devices and research-use-only devices," Rowlen said. "We've been talking to suppliers and believe that, if called upon to do so, we could print [approximately] 1,000 chips and have them ready for distribution within a month or so."
According to InDevR, the most popular laboratory diagnostic tests for flu include rapid immunoassays, which are only able to identify whether a virus is type A or B; and reverse-transcriptase polymerase chain reaction assays. Traditionally, RT-PCR tests have been designed for human-adapted flu virus and thus were not able to identify the swine H1N1 subtype; and generally were available only through the US Centers for Disease Control, and not state and local public health labs.
However, as reported last week by BTW sister publication GenomeWeb Daily News, the US Food and Drug Administration has authorized the emergency use of a CDC RT-PCR-based swine flu panel to diagnose patients in the US. The test will run on an Applied Biosystems instrument platform and will be made available through a small number of government labs.
Still, InDevR said that its test could ID the swine flu subtype in one day and therefore may be ideal for use in state public health labs to help rapidly identify cases of swine flu regionally.
"It's hard to tell how that might come about," Rowlen said. "We could make it available locally, but there is the potential that [the government] would want to put it in state public health labs, for example. Really we'd have to have the approval of the CDC that this test is the way they want to go." She added that InDevR is currently discussing this possibility with the CDC and other regulatory authorities.
And despite the fact that InDevR disclosed the licensing deal with CU last week when the swine flu story was front-page news, the concurrent timing of the licensing deal and worldwide swine flu outbreak was mostly coincidental, according to Rowlen.
"Three months ago we began negotiating with CU to get the license, and we've been negotiating pretty much the whole time, and we just reached a consensus," Rowlen said. "We had the bulk of it done before the story of the possible pandemic broke. And then this whole [swine flu] thing happened. It's a horrible thing that the country and world is facing, but in terms of timing, it turned out to be very fortuitous for us."