SBIR and STTR Success Story for
Genomics USA

(Information Posted/Updated on 05/12/2011)

Genomics USA
1622 W. Colonial Parkway
Suite 1A
Hoffman Estates, IL  60067

Contact:    Dr. Krishna Jayaraman
Phone:      847-359-1032
Fax:          87-359-1053
E-mail:      kjayaraman@gmsbiotech.com
Web Site:  http://www.gmsbiotech.com or http://www.genomicsusa.com

Project Title:  HLA Chip Product for FDA 510 (k) Approval
Related Award(s):  5R44AI060166-06; 2R44AI060166-02; 1R43AI060166-01
Technology Developed:
Genomics USA has invented and received multiple patents for a very-low-cost, simple & accurate microarray technology for complex genetic analysis, coupled to the use of unpurified samples, especially raw blood, dried blood spots, buccal swabs & saliva.

Our core microarray technology is based on direct adsorption of unmodified oligonucleotide probes with oligo dT tails on a cationic surface. The procedure is simple, easy-to- use and very economical due to the use of short unmodified oligos. Also, with SBIR funding, we have also developed a novel “Raw Sample Genotyping” Technology that allows raw blood or buccal swabs and saliva or dried blood spots to be genotyped directly without the need for DNA purification. This new approach to “Raw Sample Genotyping” is based on the use of two tandem PCR. In brief, the first PCR reaction is performed on a raw sample and a small fraction of the amplicon product from the first PCR is diluted 20-50-fold into a second PCR reaction irrespective of the yield of the amplicon to dilute out the offending inhibitors that may be present in the raw sample, under conditions that are primer limiting. By combining those two attributes [use a raw sample in the first PCR + a primer limited second PCR reaction] we have shown that raw adult blood and cheek swab samples can be used directly for microarray analysis, to produce a predetermined final amplicon concentration, thereby obviating both DNA purification & DNA quantitation in the sample preparation workflow.

The first such “Raw Sample Genotyping” products are based on the simultaneous analysis of multiple HLA genes as a single, low-cost microarray.

Key Words:  Microarray Technology, HLA Genotyping, FDA 510 (k) Approval, Raw Sample Genotyping.
Uses of Technology/Products/Service:
Beyond organ transplantation and vaccine response, there is now very strong evidence that personal variation in the HLA genes is also directly related to personal variation in the risk of viral infection; the risk of inflammatory joint disease; drug sensitivity such as Abacavir in HIV-infected patients. Some experts argue that HLA testing should be performed as part of routine childhood and adult vaccination, and for that reason, HLA-testing could become the first complex genetic test to be given routinely at birth, as part of the standard neonatal screening panel. The HLA-Chip product was developed, from its inception, to meet such large-scale clinical and public health needs, and consequently, we view the entire 12,000 test per day neonatal screening market to be a realistic sales goal within the next 5 years.

Recently, it has also become clear within the FDA & the pharmaceutical development community that specialized HLA-Typing could become a required Companion Genetic Test for a growing group of small molecule drugs: abacavir, allopurinol, lumiricoxib and others in the pipeline. We have initiated development plans to provide low-cost HLA-based companion diagnostic tests for all such HLA-related drug applications.

It is well known in diagnostic or HLA-typing labs that DNA processing can demand as much labor & reagent cost as the genetic testing itself. Thus, the ability to bypass DNA purification as embodied in our low-cost microarray testing can be viewed as a significant enabling technological advancement. More importantly, it provides considerable savings in cost and time (1/5 of the current test cost and 50% labor saving)

Benefit to Company:
The funding obtained from SBIR Phase I through Phase II continuation grants has allowed the company to successfully complete product development. The Phase II continuation grant was obtained specifically for obtaining FDA 510(k) approval of our HLA-Chip product. Beta testing is in progress with several prestigious laboratories and the 510(k) approval is expected by early 2012. ASHI (American Society of Histocompatibility and Immunogenetics) certification is being sought to enable adoption of this product for organ transplantation applications. Simultaneously, we plan to launch the HLA Chip products into the research and epidemiology markets within the next few months.

How Product Was Commercialized:
Our collaborators who are involved in beta testing are willing to use our technology for HLA typing once the testing is completed successfully. We anticipate generating revenues from these laboratories within the next 12 months. We have already been approached by companies to market our product both within and outside the US. We have also been included as a contractor of HLA Chip products and services on the grant applications of our collaborators.

The HLA Chip products are planned for launch into the research and epidemiology market by Q3 2011. Following ASHI certification we expect that our HLA typing products will be used in the organ transplantation field.

Other Comments Related to Company's Success Story:
We were successful in obtaining a Phase II continuation grant specifically for obtaining FDA 510(k) approval. Without this funding we would not have been able to initiate this important activity so quickly, which tremendously improved the value of our product. Grants have not only provided funds but crucial validation of the technology and the value of our products in the market. We have already been approached for acquisition by other companies because of our success. It has also been easier to collaborate with high profile labs because of the recognition that goes with obtaining Phase II or Phase II continuation grants.

We have been awarded crucial patents for our microarray technology and for the use of this technology in HLA typing during the course of developing the technology through the grants. With successful validation of our core technology in HLA typing, we have expanded the application to non-HLA field and have successfully obtained SBIR grants to develop products in those areas as well.

Past R&D and/or Sales from this Project:   $500K
Estimated Future Annual R&D and/or Sales from this Project:   $5 Million