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InDevR Wins BARDA Contract for Cutting-Edge Influenza Diagnostic

BOULDER, CO--(Marketwired - September 15, 2014) - InDevR, a Boulder-based life science company, announced today that it has signed a contract (HHSO100201400010C) with the Biomedical Advanced Research and Development Authority (BARDA) to complete product development of their unique influenza diagnostic, FluChip-8G, which is capable of rapidly genotyping influenza viruses directly from clinical samples. The total contract award is for up to $14.7 M, contingent upon successful completion of project milestones. "The FluChip-8G system will provide an unprecedented level of information about viruses detected in human clinical specimens, without the need for virus isolation. This information will allow physicians to make better informed decisions about treatment options for their patients," said Dr. Kathy Rowlen, InDevR's CEO Once cleared by the U.S. Food and Drug Administration, FluChip-8G will enhance clinical diagnosis of influenza in hospitals, urgent care facilities, and clinical laboratories by enabling physicians to rapidly distinguish between seasonal strains and potential pandemic non-seasonal strains of the influenza virus, such as H5N1 or H7N9. According to Dr. Aleta Bonner, Clinical Researcher and Pediatric Emergency Physician, "The potential for the FluChip-8G platform to provide both FDA-cleared results of clinical significance as well as epidemiologically-relevant results is a significant advance over currently available platforms. Influenza surveillance activities and antiviral resistance monitoring have traditionally been viewed as primarily academic and/or public health concerns. The potential for emergence and circulation of new pandemic strains as well as continued threats of bioterrorism attacks increases the need for all medical providers to have some knowledge of influenza surveillance and antiviral resistance trends. The ability of the assay to provide rapid turnaround of the patient's clinical result combined with surveillance and antiviral resistance information through delivery of real-time data makes this an incredibly robust platform. Such a platform would improve clinical decision-making and patient care while providing the ability to rapidly aggregate community level data to track antiviral resistance and other trends on a national or even international level." The contract for advanced development is supported by BARDA, part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services. Consistent with ASPR's mission, this contract supports the development of a new method for identifying emerging and potentially pandemic influenza viruses. Rowlen commented, "InDevR is thrilled about the partnership with BARDA. Their support will enable us to complete the final stages of product development and conduct clinical studies for a 510(k) submission to the FDA. If all goes well, we will launch the first commercial version of FluChip-8G in 2016."

About InDevR

InDevR is a privately held company with demonstrated commitment to innovative solutions for the life science industry. With focus on enhancing vaccines and other biotherapeutics, InDevR has emerged as a leader in progressive new analytical technologies that enable accelerated development and manufacturing of these life-saving products. For more information about the company and products, please visit www.indevr.com or call 303-402-9100.

Contact Information

MEDIA CONTACT
Cyndi Woodward
InDevR
+1-303-402-9100
cwoodward@indevr.com

GE and InDevR Develop Breakthrough Device to Improve Diagnosis of Flu at the Point-of-Care

  • Working to create a device that is easy-to-operate and can be used in the doctor’s office or remotely in the field
  • Key goal is to enable device to be quickly adapted to diagnose new strains of the flu and other emerging infectious diseases
  • Small biotech business in Boulder, Colorado partnering with GE to increase its workforce
NISKAYUNA, NY, February 23, 2011 – With the peak of flu season upon us, scientists at GE Global Research, the General Electric Company’s (NYSE: GE) central technology development arm, have been awarded a program through the Defense Advanced Research Projects Agency (DARPA) to develop a breakthrough medical device that can diagnose the flu and other infectious diseases such as malaria, E. coli and salmonella at the point-of-care. In addition to making an accurate diagnosis, another key goal of the device is to be readily adapted for new strains of diseases so that new diagnostic tests can be rapidly developed. GE scientists will be partnering with InDevR, a rapidly growing biotechnology company in Boulder, Colorado that develops new tools to assist in disease diagnosis such as the flu and vaccine development as well. GE, with deep research experience in chemistry and world-class experts in DNA and RNA analysis, will be incorporating new materials and molecular biology methods into a device being developed by InDevR. The nearly $5.8 million in funding from DARPA for the project will result in the creation of at least 7 new jobs at InDevR. Kathy L. Rowlen, PhD, InDevR’s CEO and Chief Science Officer, said, “We are thrilled to be working with GE Global Research. The partnership offers a powerful combination of InDevR’s strengths in virus identification and instrument development with GE’s global leadership in healthcare products, technologies and services. The DARPA contract will not only support innovative research to improve flu diagnosis, it will administer a healthy shot in the arm for Boulder’s economy in the form of new, high-paying technology jobs at InDevR.” Erin Finehout, a lead engineer at GE Global Research and principal investigator on the DARPA project, said, “Today, the flu can be diagnosed in the doctor’s office, but often patient samples need to be sent out to a lab to confirm a diagnosis and provide more information about a patient’s condition. GE and InDevR intend to develop a device that brings this analysis to the point-of-care at the doctor’s office, a remote military base, or the site of a humanitarian mission responding to a major health care pandemic.” According to the Centers for Disease Control and Prevention (CDC), as much as 20% of the U.S. population will get the flu during flu season. Of that population, about 200,000 end up being hospitalized for treatment. The hope is that faster, more accurate diagnosis of the flu and other respiratory viruses upfront will lead to improved patient treatment and a reduced number of severe cases. GE and InDevR scientists are working to develop a device that is highly portable, easy to use and requires little training. This would allow a broader range of medical providers to operate the device and enable it to be used in clinical settings that would reach more people in need of care. DARPA is interested in having a device that could be used in the field to help assess soldiers deployed in remote areas where access to care is limited. This device also is being targeted for use by medics sent out by the U.S. military on humanitarian missions and for disaster relief efforts. Another key goal for the device is to make it readily adaptable for recognizing new strains of the flu and other infectious diseases. Finehout explained this could be achieved if it can simultaneously analyze multiple types of biomolecules (DNA, RNA, and protein) in a patient sample. Most diagnostic platforms are only designed to work with one of these types of molecules. This versatility will allow for system that not only can be readily modified to recognize new strains, but also diagnose a wide variety of different diseases. This kind of adaptability and versatility is not possible in current devices on the market today.

About GE Global Research

GE’s businesses. Our scientists and engineers redefine what’s possible, drive growth for our businesses, and find answers to some of the world’s toughest problems. We innovate 24 hours a day, with sites in Niskayuna, New York; San Ramon, California; Bangalore, India; Shanghai, China; Munich, Germany; and Rio de Janeiro, Brazil. Visit GE Global Research on the web at www.geglobalresearch.com. Connect with our technologists at http://www.geglobalresearch.com/blog and http://twitter.com/geresearch

About InDevR

InDevR, one the West’s fastest growing biotechnology companies was founded in 2003 to develop breakthrough life science instrumentation. In 2010, InDevR launched the ViroCyt® 2100 Virus Counter® for rapid virus quantification to streamline vaccine development. InDevR’s latest product, ampliPHOX® is new, colorimetric detection technology for low density microarrays. For more information about the company, please visit www.indevr.com.

Kathy Rowlen, InDevR's CEO, a guest blogger for GE Global Research: Low Complexity Microarrays: Ascendant Technology for Cost Effective Diagnostics Full text: A recent analysis found that the global microarray market was valued at $2.6 billion in 2010 with significant growth anticipated for the next several years.  To date the microarray market has been defined by high density arrays, which contain thousands of bits of information per test, offered by companies such as Affymetrix, Agilent, and Illumina.  Primary applications for high density microarrays include gene expression profiling, biomarker profiling, and more recently cancer diagnostics. According to the cited market report, growth in the microarray market is expected to come from the personalized medicine drive in healthcare as well as advances in lab-on-a-chip (LOC) technology.  However, given the cost and complexity associated with each high density microarray experiment, and emerging competition from alternate genome sequencing technologies, there is concern that the high density microarray technology may actually lose ground.  For example, Life Technologies acquired theIon Torrent’s technology for rapid genome sequencing and claims that it will meet the goal of a “$1000 genome” by the end of 2012. The other driving force for microarray market growth, lab-on-a-chip, is based on the concept that a complete chemical or biochemical assay, from sample to result, can be engineered into a single, compact device.  While the technology has been slowly evolving over the past couple of decades, it appears to be finally emerging as a new tool for diagnostics.  One promising field combines the multiplexing capabilities of microarrays with the efficiency of LOC. For infectious disease diagnostics, success in the marketplace demands that the assay information content be balanced against cost.  Many small biotech companies are therefore focused on developing low complexity microarrays in conjunction with a fully automated LOC platform.  Low complexity microarrays typically contain 10-100 bits of information (in contrast to thousands) and tend to focus on specific targets rather than broad spectrum profiling.  Examples of low complexity microarrays in commercial development include InDevR’s FluChip assay for rapid strain identification of influenza, Great Basin’s MRSA array for identification of methicillin-resistant staphylococcus aureus, and Rehonix’s CARD system for identification of 20 human papillomavirus types. In what we believe is an exciting new chapter in the story of low complexity microarrays and LOC, GE announced today that the Defense Advanced Research Projects Agency (DARPA) is sponsoring development of a breakthrough diagnostic platform capable of simultaneously analyzing nucleic acids and proteins for application to a broad range of diagnostic applications. GE scientists will be partnering with InDevR to develop a device that is highly portable, easy to use and requires little training.  DARPA is interested in new, cost effective healthcare tools that can be used at the point-of-care to aid soldiers in the field or on humanitarian missions in remote areas where access to care is limited. At the heart of the new platform will be an assay built around GE’s easy-to-use reagents and InDevR’s low complexity microarrays for diagnosing respiratory virus infections, including influenza.  We are excited to be a part of this rapidly evolving field and see a bright future for the “less is more” approach.

InDevR awarded $3 million grant from NIH for influenza-related research

BOULDER, Colo. - March 11, 2011 - InDevR announced today that it has been awarded a Phase II Small Business Innovation Research grant from the National Institutes of Health in the amount of $3 million over the next 3 years. The grant, titled "Simultaneous Screening for A/H3N2, A/H1N1, A/H5N1 and B Influenza Viruses," will fund the development of an integrated sample-to-result molecular diagnostic platform for which influenza screening is the first targeted test. "We are delighted to receive continued support from the NIH to advance our FluChip technology for accurate, rapid and cost-effective identification of influenza viruses," said Kathy L. Rowlen, PhD, InDevR's CEO and Chief Science Officer. The grant was issued by the National Institute of Allergy and Infectious Diseases and comes at the completion of a successful $600,000 two-year Phase I award to refine a low-density microarray assay for influenza virus identification. Rowlen said Phase II efforts will focus on combining the FluChip low-density microarray with a colorimetric detection method (ampliPHOX) and integrating the entire assay into a cost-effective, cartridge-based instrument platform targeted for eventual clinical diagnosis. The foundational intellectual property associated with the FluChip™ and ampliPHOX™ technologies are licensed from the University of Colorado Boulder. According to David Allen, Associate Vice President at the University of Colorado Technology Transfer Office, "The combination of InDevR's FluChip and ampliPHOX technologies represents a promising and innovative approach and that could have high impact on influenza diagnostics."
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About InDevR

InDevR, one the West's fastest growing biotechnology companies was founded in 2003 to develop breakthrough life science instrumentation. In 2010, InDevR launched the ViroCytTM 2100 Virus Counter® for rapid virus quantification. For more information about the company, please visit www.indevr.com

About the Technology Transfer Office and the University of Colorado

The CU Technology Transfer Office (TTO) pursues, protects, packages, and licenses to business the intellectual property generated from research at CU. The TTO provides assistance to faculty, staff, and students, as well as to businesses looking to license or invest in CU technology. For more information about technology transfer at CU, visitwww.cu.edu/techtransfer.

InDevR Featured in Schott's Microarray Solutions Newsletter: Low-Density Microarrays with ampliPHOX™ Colorimetric Detection based on Nexterion® Slide AL.

InDevR to Collaborate with Scientists at the CDC to Develop New Influenza Virus Surveillance Assay

InDevR, developer of advanced life science products, announced its collaboration with scientists in the Influenza Division of the Centers for Disease Control and Prevention (CDC) in Atlanta to develop a unique influenza microarray assay. InDevR and CDC scientists are working to develop a low density microarray capable of screening influenza A viruses for genetic reassortment. The microarray will be coupled with InDevR’s inexpensive, compact ampliPHOX™ colorimetric detection system. This simple yet powerful microarray assay has the potential to enhance influenza surveillance efforts around the globe by providing an affordable tool for public health scientists that do not have access to full genome sequencing. Enabling point of service screening will help to more efficiently track the emergence of viruses like the swine origin H1N1, where genetic mixing occurred between influenza viruses adapted to different species. Funded by an internal CDC grant, the microarray will be developed over the next two years. “We are excited about this collaboration with CDC that will leverage our combined experience with low-density microarray development, CDC’s expertise in influenza surveillance, and InDevR’s unique new ampliPHOX colorimetric detection technology. This compelling combination of technologies could greatly enhance global influenza surveillance efforts, which in turn, will provide essential and time-critical information for vaccine preparation,” said Dr. Kathy Rowlen, InDevR’s co-founder and CEO.

About InDevR

InDevR is a privately held company that develops advanced life science instrumentation and assays for analysis of viruses and other microorganisms. InDevR intends to revolutionize microbiological analysis with affordable, easy-to-use instrumentation and assays that deliver reliable results in less time than required for traditional methods. Designed for application in fields ranging from vaccine development to surveillance of pathogens, InDevR’s products streamline microbiological analysis. More information about InDevR’s products and services can be found at www.indevr.com

InDevR authors a book chapter entitled: MChip: a Single Gene Diagnostic Microarray for Influenza A Influenza: Molecular Virology, February 2010, by Erica D. Dawson and Kathy L. Rowlen.

In May the Boulder based company InDevR showed that their FluChip genetic test can distinguish the current swine flu from other varieties, by Amber Angelle, Discover, October 2009.

Cover story in Chemical and Engineering News: "Reliable, Easy-To-Use Tests Could Aid Treatment", by Ann M. Thayer. Article describes InDevR's FluChip for identifying H1N1 and other influenza strains and plans by InDevR to place the FluChip technology in 20 public health labs.

Boulder, CO - (May 5, 2009) - InDevR, a small biotech company in Boulder, CO, and the Influenza Division of the Centers for Disease Control and Prevention (CDC) in Atlanta confirmed today that the M gene version of InDevR’s FluChip can detect swine-origin H1N1 influenza A viruses and clearly distinguish them from seasonal influenza viruses (A/H1N1 and A/H3N2) as well as the deadly avian A/H5N1 virus. The CDC provided InDevR scientists with non-infectious genetic material from swine-origin influenza viruses earlier this week. The FluChip performance was evaluated with several of these samples in a side-by-side comparison with seasonal human influenza viruses. “The FluChip assay detected all of the 6 swine-origin H1N1 viruses tested, and the resulting pattern, or signature, on the microarray was dramatically different than the signature for seasonal A/H1N1 and A/H3N2 viruses. Interestingly, the signature of the swine H1N1 virus indicated an avian component within the M-gene, which is consistent with its reported Eurasian lineage," said Dr. Erica Dawson, the Lead Scientist on the project at InDevR and co-inventor of the FluChip technology. The FluChip is expected to be a powerful addition to the influenza surveillance toolkit since it will be less susceptible to failure than qRT-PCR assays as the virus continues to evolve. According to Rowlen, who is now CEO at InDevR, the reason that the M-gene version of the FluChip is more robust has to do with the fact that the diagnostic target is a stable, internal gene which codes for the virus’ matrix proteins. Current qRT-PCR subtyping assays target a more highly mutable gene that codes for a protein, hemagglutinin (HA), which is subject to antigenic drift. “As has happened in the past, if the HA gene changes in a critical region, qRT-PCR will fail and the researcher won’t know why until the gene is re-sequenced,” said Rowlen. Based on these early FluChip results and with support from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), InDevR will immediately begin manufacturing FluChip Kits for placement in a limited number of State Public Health labs. The Colorado Department of Public Health and Environment (CDPHE) will be the first site to receive FluChip assays for use as a complement to the newly released swine qRT-PCR assay. “We are excited about helping to evaluate the FluChip technology. The ability to rapidly and reliably determine whether or not an influenza virus is seasonal or extraordinary would be tremendous,” said Dr. Hugh Maguire, Program Manager of Microbiology and Molecular Science at the CDPHE. InDevR will combine the FluChip technology with an innovative detection technology (NESA™), which InDevR also licensed from the University of Colorado and further developed with NIAID support, to make the FluChip assay inexpensive and easy to use in any lab that has basic PCR capabilities.

About InDevR

InDevR is a small, privately held biotechnology company in Boulder, CO. Founded in 2003, InDevR employs a highly motivated team of individuals dedicated to the development and commercialization of innovative technologies that will help fill gaps in the current paradigm for virus-related diagnostics. The FluChip was invented by a joint team of scientists at the University of Colorado and the Centers for Disease Control and Prevention in an NIAID-supported effort led by then Professor Kathy Rowlen. InDevR recently licensed the intellectual property from the University of Colorado and CDC.  

InDevR Inc. Licenses FluChip Technology to Combat Deadly Flu Virus

Boulder, CO - (April 28, 2009) - InDevR, a small biotech company in Boulder, CO, announced today that they have licensed the FluChip technology from the University of Colorado. The FluChip was invented by a joint team of scientists at the University of Colorado and the Centers for Disease Control and Prevention in an NIH sponsored effort led by Professor Kathy Rowlen. Rowlen, now the CEO of InDevR, said that InDevR has arranged to test genetic material from the recent swine H1N1 virus on the MChip as well as other versions of the FluChip which are under development. According to Rowlen “Based on work we conducted a couple of years ago, it appears that the M-gene version of the FluChip will be able to distinguish human H1N1 viruses from the new swine H1N1 virus. If that proves to be the case, the FluChip will be a much needed and powerful new tool for surveillance since all of the current influenza diagnostics on the market are unable to subtype this virus.” The most popular diagnostic tests for influenza include rapid immunoassays, which are only able to identify the type (A or B) of influenza virus, and reverse-transcriptase polymerase chain reaction assays, which were designed for human-adapted influenza viruses and are not able to identify the swine H1N1 subtype. State Public Health Laboratories must now send any influenza A viruses that cannot be subtyped using existing diagnostics to the CDC for analysis by genome sequencing or viral isolation. The CDC must select viruses to analyze since it is not possible to run every sample collected from a large number of Public Health Labs. The M-gene based FluChip has been demonstrated to delineate human-adapted viruses from non-human viruses, such as the H1N1 virus that caused the 1918 “Spanish Flu”. “Since the FluChip assay can be conducted within a single day it could be employed in State Public Health Laboratories to greatly enhance influenza surveillance and our ability to track the virus,” Rowlen said. InDevR will combine the FluChip technology with an innovative detection technology (NESATM), which InDevR also licensed from the University of Colorado and further developed with NIH sponsorship, to make the FluChip assay inexpensive and easy to use in any lab that has basic PCR capabilities. “Kathy and her team have been engaged with this and similar diagnostic technology for many years,” said Mary Tapolsky, Senior Licensing Manager at the University of Colorado Technology Transfer Office. “CU TTO is excited about this experienced and motivated group developing and commercializing this promising technology.”

About InDevR

InDevR is a small, privately held biotechnology company in Boulder, CO. Founded in 2003, InDevR employs a highly motivated team of individuals dedicated to the development and commercialization of innovative technologies that will help fill gaps in the current paradigm for virus-related diagnostics. InDevR is poised to launch two products later this year: the Virus Counter for rapid virus quantification of viruses, and a pathogen detection platform based on low-density microarrays and novel signal amplification technology.

Contact Information

Person: Kathy Rowlen, CEO InDevR Phone: 303-402-9100 Email: Rowlen@indevr.com Website: www.indevr.com Person: Lindsay Polak, Marketing & Communications Manager University of Colorado Technology Transfer Office Phone: 303-735-5518 Email: lindsay.polak@cu.edu Website: www.cu.edu/techtransfer

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