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INDEVR, INC

Address

6035 LONGBOW DR STE 102
BOULDER, CO, 80301-3294
USA

UEI: CX4ZCPH2EAA3

Number of Employees: N/A

HUBZone Owned: No

Woman Owned: Yes

Socially and Economically Disadvantaged: No

SBIR/STTR Involvement

Year of first award: 2004

Phase I Awards

Phase II Awards

66.67%

Conversion Rate

$4,259,266

Phase I Dollars

$10,703,193

Phase II Dollars

$14,962,459

Total Awarded

Awards

Up to 10 of the most recent awards are being displayed. To view all of this company's awards, visit the Award Data search page.

Innovative Optical System for Hemagglutination Assays

Amount: $1,991,388 Topic: NIAID

PROJECT SUMMARY The Hemagglutination assay HA and Hemagglutination Inhibition HI assay are widely used methods for characterizing viruses bacteria and antibodies The World Health Organization recently recommended that HI remain the gold standard method for influenza seroepidemiology Although the HA and HI assays are applied worldwide they have the disadvantages of manual plate reading non specific inhibition and other operational limitations causing poor reproducibility and inconsistent results between laboratories This proposal primarily addresses the manual reading challenge by developing an instrument to record and analyze digital images of HA and HI assay plates In Phase I InDevR developed and launched a first generation instrument with an intuitive user interface and excellent HA and HI titer agreement with expert human readers The Specific Aims for Phase II are to develop an advanced image analysis algorithm for challenging seroepidemiology samples enhance the Cypher HA HI reader to create a walk away high throughput system integrated with commercial automated plate handling equipment and sample tracking and validate reader performance at facilities to demonstrate agreement with human experts and overall operational effectiveness The advanced image analysis algorithm will analyze and compare specific features of control wells with sample wells Preliminary results have shown greater than agreement with expert human readers including to ability to overcome non specific inhibition and its effects on image interpretation The new system will also support improved results transfer and LIMS integration The high throughput system will be most valuable to laboratories like the FDA CBER`s group as well as WHO Collaborating Centers that select seasonal influenza vaccine antigens during peak periods using thousands of HA and HI assays PROJECT NARRATIVE InDevR`s automated reader Cypher for hemagglutination assay HA and hemagglutination inhibition HI assays will enable laboratories that are involved in selecting developing and manufacturing a wide range of vaccines including Ebola and HIV to operate with more consistency and accuracy The Cypher system can also be applied to many other agglutination assays in diagnostics and hematology

SBIR

Phase II

2016

HHS

NIH

TITER ON CHIP ALTERNATIVE TO SRID FOR INFLUENZA VACCINE POTENCY DETERMINATION

Amount: $3,321,832 Topic: NIAID

DESCRIPTION provided by applicant It is widely acknowledged that for split vaccines potency determination is often a rate limiting step The FDA approved andquot gold standardandquot potency assay for influenza hemagglutinin HA protein based vaccines is single radial immunodiffusion SRID SRID is a time and labor intensive assay often requiring days to complete and a minimum of hours hands on time by well trained analysts Costs for SRID analysis for both pre licensure and post licensure testing can be more than $ million per year for each production facility In terms of impact on the seasonal influenza vaccine development process perhaps even more important are the development and production delays imposed by the time required for new reference antisera Even with reference materials in hand the wait for results can be days for each round of clone assessment prior to moving forward in development Overall the result is a recognized inefficient step in the vaccine development process If funded this project will result in an innovative off the shelf product that eliminates the need for referece antisera The Flu Titer on Chip product will enable vaccine producers to dramatically reduce costs standardize results and deliver flu vaccines to market faster by streamlining quantification of hemagglutinin at all stages of vaccine development from in process to bulk drug substances through to tri or quadrivalent vaccine formulations PUBLIC HEALTH RELEVANCE InDevR will develop a product Flu TOC that will enable vaccine producers to dramatically reduce costs standardize results and deliver flu vaccines to market faster by streamlining quantification of hemagglutinin at all stages of vaccine development from in process to bulk drug substances through to tri or quadrivalent vaccine formulations

SBIR

Phase II

2014

HHS

NIH

INNOVATIVE OPTICAL SYSTEM FOR HEMAGGLUTINATION ASSAYS

Amount: $600,000 Topic: NIAID

DESCRIPTION provided by applicant We propose to eliminate the time consuming manual plate readout for hemagglutination assays by developing an innovative well plate and associated optical reader capable of accurately and rapidly determining hemagglutination and associated titer values in a fully automated system The need for improved analytical tools for vaccine development and production is evidenced by the robust cross agency initiative to improve influenza vaccine manufacturing Influenza Vaccine Manufacturing Optimization Program which is a collaborative effort between NIH BARDA FDA and the CDC One identified problematic step in influenza vaccine development is the hemagglutination HA and hemagglutination inhibition HAI assays used to characterize influenza viruses Currently HA HAI assays are conducted in well plates which are read andquot by eyeandquot The user must evaluate each well and manually record a for hemagglutination and a for no hemagglutination While many of the liquid handling steps of assay preparation can be automated plate reading is exclusively manual since no commercially available plate readers can differentiate positive and negative hemagglutination InDevR has an excellent track record in translating innovative concepts into impactful products InDevR is a privately held biotechnology company located in Boulder Colorado that develops and commercializes breakthrough detection and quantification technologies for microbiological analysis Founded in by members of the Chemistry Department at the University of Colorado the company today has employees and has taken two products to market that are now being sold world wide InDevR conducts all research development and manufacturing activities in house PUBLIC HEALTH RELEVANCE We propose to eliminate the time consuming manual plate readout for hemagglutination assays by developing an innovative well plate and associated optical reader capable of accurately and rapidly determining hemagglutination and associated titer values in a fully automated system

SBIR

Phase I

2014

HHS

NIH

TITER ON CHIP: ALTERNATIVE TO SRID FOR INFLUENZA VACCINE POTENCY DETERMINATION

Amount: $600,000 Topic: NIAID

DESCRIPTION (provided by applicant): There is a tremendous need for new analytical methods to enhance vaccine research and development, ultimately allowing the production of safe and efficacious vaccines in less time at less cost. For example, it is well known that for splt vaccines one step in the process that can be rate limiting is protein quantification and potency determination. The FDA approved gold standard potency assay for influenza hemagglutinin protein based vaccines is single radial immunodiffusion (SRID). SRID is a time and labor intensive assay, often requiring 2-3 days to complete and a minimum of 6 hours hands on time by well trained analysts. While the reference reagents are provided at no cost by the Center for Biologics Evaluation andResearch (CBER), additional materials must be purchased and the entire assay prepared and validated by each vaccine producer. Often vaccine producers experience long delays, sometime months, in receiving reference reagents. Even with reference materials inhand, the wait for results can be days for each round of clone assessment prior to moving forward in development. As is widely acknowledged, the overall result is a time-consuming and inefficient vaccine development process. Here we propose two new quantitative, multiplexed analytical methods based on cost-effective low density microarrays. Both assays are based on a Titer on Chip approach that will streamline vaccine potency measurements by substantially reducing time to result, eliminating inter-laboratory variations associated with assay preparations, and reducing reagent cost. One proposed assay relies (Specific Aim I) on monoclonal antibodies that are universally responsive to hemagglutinin subtypes for influenza (e.g., H1, H3, H5). The other proposed assay (Specific Aim II) relies on universal sialic acid glycoproteins that bind hemagglutinin to achieve rapid HA protein quantification without the need for strain specific antibodies. We believe that Titer on Chip has the long term potential to revolutionize influenza vaccine potency determination. PUBLIC HEALTH RELEVANCE: There is a tremendous need for new analytical methods to enhance vaccine research and development, ultimately allowing the production of safe and efficacious vaccines in less time at less cost. Here we propose two new quantitative, multiplexed analytical methods based on cost-effective low density microarrays. We believe that Titer on Chip has the long term potential to revolutionize influenza vaccine potency determination.

SBIR

Phase I

2012

HHS

NIH

SIMULTANEOUS SCREENING FOR A/H3N2, A/H1N1, A/H5N1 AND B INFLUENZA VIRUSES

Amount: $2,988,813 Topic: NIAID

DESCRIPTION (provided by applicant): The objective for this Phase II application is to develop a cartridge-based automated molecular diagnostic platform to rapidly and cost-effectively detect and identify influenza viruses. The system will automate all keyfunctions for sample processing including extraction, amplification, colorimetric detection on a low- density microarray, and image/result interpretation. The idea is to make the system easy to use so that personnel with no PCR or microarray experience could obtain an unequivocal answer with minimal hands- on time. The motivation for the proposed work is the tremendous impact influenza viruses have on human and animal health and the need for rapid, inexpensive tools for strain surveillance. The intent is to significantly enhance influenza virus surveillance by providing a new tool to affordably and rapidly identify influenza viruses without expertise in PCR methods and without exclusive reliance on existing, sometimes poor performing, rapid immunoassays. The marketing plan involves providing the instrument to customers at no capital cost (i.e., the reagent rental concept). Therefore, the instrument will be designed with simplicity and low cost in mind. Our market entry point will be influenza surveillancesites, such as state public health labs, where the FluChip assay could be used to track viruses without the need to diagnose patients. Long term, we will use data acquired in these early studies to formulate an FDA submission for 510(k) clearance for use as an in vitro diagnostic. PUBLIC HEALTH RELEVANCE: The objective of the proposed work is to build on the success achieved in Phase I for rapidly identifying influenza viruses by developing a cartridge based system for automated and self-contained sample processing, including extraction, amplification, and colorimetric detection on a low-density microarray.

SBIR

Phase II

2011

HHS

NIH

Monitoring System For Vector-Based Influenza Vaccine

Amount: $2,401,160

DESCRIPTION (provided by applicant): This Phase II Advanced Technology SBIR [PA-06-134] proposal is in response to NIAID's Notice of High-Priority Influenza Research Areas [NOT-AI-05-013]. In order to provide health officials with the tools required to eff iciently combat a pandemic strain of influenza, it is essential that rapid and cost-effective methods for vaccine production be developed. The proposed instrument is specifically designed to provide a rapid count of the number of intact viruses per unit volume in liquid. While optimization of vaccine production methods is an example application for which the number of intact viruses is a valuable measurement, the time and cost savings of virus enumeration within minutes, rather than days, is anticipated t o have substantial impact on several other virus-related fields. Support for that outlook is provided by the excellent group of collaborators we have been able to assemble during the Phase I efforts, including scientists from two large vaccine manufacturer s (MedImmune and Novartis), a small cutting-edge vaccine manufacturer (Protein Sciences Corporation), a biological reagents company (Microbix Biosystems, Inc.), a diagnostics company (Quidel Corporation), and a College of Medicine (at Baylor). All Phase I objectives were achieved and in many cases exceeded. During Phase II efforts we will i) design and construct an advanced prototype Virus CounterTM and develop automated methods for instrument parameter setup; ii) evaluate instrument performance in comparis on with standard methods such as plaque assays, fluorescence focus assays, transmission electron microscopy and real-time quantitative PCR, iii) optimize the Virus CounterTM and assay for utility in vaccine production, and iv) conduct beta-site testing of the instrument. PUBLIC HEALTH RELEVANCE: In order to provide health officials with the tools required to efficiently combat a pandemic strain of influenza, it is essential that rapid and cost-effective methods for vaccine production be developed. T he proposed instrument is specifically designed to provide a rapid count of the number of intact viruses per unit volume in liquid. While optimization of vaccine production methods is an example application for which the number of intact viruses is a val uable measurement, the time and cost savings of virus enumeration within minutes, rather than days, is anticipated to have substantial impact on several other virus-related fields.

SBIR

Phase II

2008

HHS

NIH

SIMULTANEOUS SCREENING FOR A/H3N2, A/H1N1, A/H5N1 AND B INFLUENZA VIRUSES

Amount: $597,128

DESCRIPTION (provided by applicant): Our objective is to develop a commercially viable influenza diagnostic for rapid and simultaneous screening of clinical samples for influenza A and B type and important subtypes. The advantages of the proposed approach over existing polymerase chain reaction (PCR) methods for influenza viruses stem from the use of a single gene segment for identification of both type and subtype. The target for the proposed work, the matrix gene segment, is known to be robustly amplified and more conserved than the traditional hemagglutinin gene (HA) target. The initial commercial niche for the developed product will be state and local public health laboratories. While state health labs currently receive clinical samples for typing and su btyping, the cost of subtyping by the gold standard of viral isolation and hemagglutination inhibition test is prohibitive. Currently, most health labs rely on a fluorescence-based immunoassay to screen for H3 or H1 viruses, with no confirmation of the n euraminidase subtype and no current capabilities for emerging viruses. Those labs that utilize real-time reverse transcription PCR (RRT-PCR) assays must rely on the mutation- susceptible HA gene for partial subtyping and must conduct individual tests for e ach HA subtype. The proposed product would serve as a means to improve and broaden surveillance efforts at state and local levels in the US, as well as in regional labs worldwide, by providing a rapid and cost-effective means to simultaneously screen for t ype (A and B) and certain subtypes, specifically, current human-adapted influenza viruses (A/H3N2 and A/H1N1) and A/H5N1. This new surveillance tool would be used in place of existing immunoassays and singleplex HA targeted RT-PCR based assays but is not d esigned to replace viral isolation methods and sequencing, which are necessary for a more complete understanding of influenza viruses. Specific Aim 1 will capitalize on the recent discovery that the matrix gene segment of influenza's viral genome c an provide both type and subtype information for influenza viruses. The hypothesis to be tested is that a small set of M gene segment specific primers pairs (5) for RT-PCR can be designed to selectively detect A/H3N2, A/H1N1, A/H5N1, and B viruses. Specifi c Aim 2 will focus on systematic optimization of multiplex conditions for RT-PCR. In Specific Aim 3, promising primer sets that satisfy the criteria for success with initial samples will be validated in a blind study of 300+ patient samples acquired over a t least two flu seasons by a variety of sampling methods, including nasal swab, nasal wash, and nasopharyngeal aspiration. In Phase 2 we will engineer a system for automated sample handling, including extraction and RT-PCR amplification, followed by rapid separation and detection of PCR products by a fast chromatographic method. Post-PCR separation and detection is anticipated to provide superior accuracy and sensitivity relative to multiplex RRT- PCR with no added time to the overall assay. The mot ivation for the proposed work is the tremendous impact influenza viruses have on human and animal health and the need for rapid, inexpensive tools for strain surveillance. The intent is to provide state and local public health laboratories with the ability to affordably and rapidly screen patient samples for influenza type and subtype using the highly reliable and conserved matrix gene segment as the identification target.

SBIR

Phase I

2008

HHS

NIH

Monitoring System For Vector-Based Influenza Vaccine

Amount: $597,544

DESCRIPTION (provided by applicant): This Advanced Technology proposal is in response to NIAID's recently issued Notice of High-Priority Influenza Research Areas [NOT-AI-05-013]. In order to provide health officials with the tools required to efficiently combat a pandemic strain of influenza, it is essential that rapid and cost-effective methods for vaccine production be developed. Viral expression vectors offer a promising strategy for production of vaccines based on antigenic proteins such as hemagglutinin (HA). The proposed work is in support of efforts to develop alternate methods for vaccine production. Specifically, the proposed work centers on the development of a virus and HA quantification system that would significantly improve process control and reduce production time and costs, thereby enhancing vaccine production capabilities. Objective 1. One goal of the proposed research is to develop an innovative compact dual channel virus counter (DCVC) and assay for commercial application to viral expression vector systems. The hypothesis that a count of "intact" viruses is representative of "active" viruses will be rigorously tested. The short-term focus will be on the baculovirus expression vector system (BEVS) developed by Protein Sciences Corporation (PSC) for the generation of influenza vaccine. However, the DCVC would be equally applicable to other vector systems, such as the GenVec's adenovector technology currently being developed for production of malaria and HIV vaccines. Objective 2. The second goal is to develop an assay, in conjunction with the DCVC, which will provide rapid quantification of HA generated during the BEVS vaccine production process. The hypothesis to be tested is that the DCVC can be used to directly quantify HA on cell surfaces and that value is correlated with levels isolated from cell paste. Currently, PSC evaluates cell culture harvest of HA using an indirect method based on cell viability, which is correlated with HA production. Direct and rapid quantification of HA on the host cell surface during would greatly enhance process control for the baculovirus expression system and would result in significant reduction in manufacturing cost for vaccines. Both objectives for the monitoring system will require FDA approval for application to vaccine production. The proposed instrument and assays would aid in streamlining influenza vaccine production. In the event of an influenza pandemic, rapid vaccine production will play a key role in minimizing loss of life.

SBIR

Phase I

2006

HHS

NIH

Advanced Detection Technologies for Biochips

Amount: $932,297

DESCRIPTION (provided by applicant): The long-term objective of the proposed work is the development of innovative detection technologies for biochips (a.k.a. DNA microarrays). It is envisioned that the proposed technologies will enable the application of biochips to biodefense, particularly when a rapid and reliable diagnostic screen is required in the field. The Specific Aims of the proposed work are 1) development of an on-chip signal amplification technique that does not require enzymes, and 2) development of an inexpensive field-portable microarray reader to be used in combination with on-chip amplification. In order to focus initial efforts we have chosen to work in conjunction with NIH funded scientists who are developing a specific application, an influenza A biochip. Because influenza A is an easily transmitted, primarily airborne pathogen, and because this virus can be genetically engineered into novel forms, it represents a serious biodefense concern. In addition, the influenza A virus has a significant impact on human health, with an estimated 500,000 and 1,000,000 deaths worldwide each year, and worldwide surveillance is essential. Finally, influenza A can serve as an excellent model system for development and thorough testing of on-chip signal amplification and a field portable microarray reader.

STTR

Phase I

2004

HHS

NIH

Advanced Detection Technologies for Biochips

Amount: $932,297

SBIR

Phase I

2004

HHS

NIH