Mediomics, LLC Receives Qualifying Therapeutic Discovery Project Award

Mediomics LLC Receives Qualifying Therapeutic Discovery Project Award

Stereotaxis Awarded $1.5 Million in Grants under the Qualifying Therapeutic Discovery Project Program

PRESS RELEASE ST. LOUIS, November 08, 2010

Mediomics, LLC has been awarded $244,479 in grants from the Departments of the Treasury and Health and Human Services for the Qualifying Therapeutic Discovery Project (QTDP) to advance  the development of quick, robust and affordable PINCER-based biosensors for detect multiple biomarkers for cardiovascular disease. The biomakers include troponin I, D-dimer, CK-MB, BNP, myoglobin and C-reactive protein.  Since 2002, Mediomics has received more than three million dollars of US government funding to develop its quick and sensitive homogenous PINCER™ protein assay.

Mediomics is currently focused on developing a sustainable, profitable biotechnology business that provides innovative assay kits, biosensors and microarrays for academic and corporate research, point of care testing, food and pharmaceutical production process control, as well as the medical and environmental research markets.  These assay kits will be used to quantify most biologically and therapeutically important macromolecules, including ligands, proteins, protein complexes, and pathogens, including bacteria, fungi and viruses.  By 2012, it has been estimated that the global market for biosensors will reach approximately $6.1 billion dollars.

The company’s rapid, mix-and–measure homogeneous assays have already been adapted for the detection of a range of biologically and therapeutically important macromolecules, including cAMP, tryptophan, S-adenosyl methionine, PDE assay, biotin, insulin, C-peptide, albumin, C-reactive protein (hCRP), IgG, IgM, E. Coli,  and others.

“Early diagnosis remains one of the most important factors determining the rate of cure for cancer patients. Mediomics’ PINCER technology will provide affordable and accessible prevention testing for cancer diagnosis, which we expect will have significant impact on the goal of curing cancer in next 30 years. “We are very appreciative of the recognition and support provided by this award.  This grant will be extremely helpful to move this technology into mainstream applications,” said Mediomics President, Dr. Yie-Hwa Chang.”

About the Qualifying Therapeutic Discovery Project program The Qualifying Therapeutic Discovery Project tax credit, which can also be administered as a grant, is provided under section 48D of the U.S. Internal Revenue Code (IRC), enacted as part of the Patient Protection and Affordable Care Act of 2010. The program is targeted to therapeutic discovery projects that show a reasonable potential to result in new therapies to treat areas of unmet medical need or prevent, detect or treat chronic or acute diseases and conditions; to reduce the long-term growth of health care costs in the United States; or to significantly advance the goal of curing cancer within 30 years. Allocation of the credit or grant also takes into consideration which projects show the greatest potential to create and sustain high-quality, high-paying U.S. jobs and to advance U.S. competitiveness in life, biological and medical sciences. The credit or grant is only available to taxpayers with no more than 250 employees.

About Mediomics, LLC: Dr. Yie-Hwa Chang founded the Company in August 2001.  The Company is commercializing core technologies for which it has secured an exclusive license from Saint Louis University, including the following: (i) a DNA-binding protein-based bioassay, biosensor and biochip platform, (ii) a related variant – the molecular PINCER™-based homogeneous biosensor, bioassay, biochip platforms and companion devices, and (iii) innovative, proprietary methods to screen and develop new high-affinity capture reagents for research, diagnostic and therapeutic use.

For additional information, visit the website at www.mediomics.com, or contact Margaret Meng, Chief Administrative Officer, by phone at (314) 971-3028.

Mediomics, LLC Receives Phase II SBIR Contract: Awarded $997,251 to Develop New In-Process Analyzer for Biologics

PRESS RELEASE ST. LOUIS, October, 2012

Mediomics, LLC has been awarded a $997,251 Phase II SBIR contract (HHSN261201200081C) from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services. This project builds on successful Phase I research, and aims to develop a fully automated in-process analyzer to monitor the titer and quality of recombinant biologics. Using Mediomics’ innovative molecular PINCER® platform, Phase II work will include development of more quantitative antigen-specific assays for antibody titer, affinity, glycosylation and aggregation. This project will culminate with beta-testing by Gallus Biopharmaceuticals, a leading cGMP biologics contract manufacturing organization.

Mediomics is currently focused on developing a sustainable, profitable biotechnology business that provides innovative assay kits, biosensors and microarrays for academic and corporate medical and environmental research, point of care testing, and food and pharmaceutical production process control.  These assay kits will be used to quantify most biologically and therapeutically important macromolecules, including ligands, proteins, protein complexes, and pathogens, including bacteria, fungi and viruses.  By 2012, it has been estimated that the global market for biosensors will reach approximately $6.1 billion dollars.

The company’s rapid, mix-and–measure homogeneous assays have already been adapted for the detection of a range of important macromolecules, including cAMP, tryptophan, S-adenosyl methionine, PDE, biotin, insulin, C-peptide, albumin, C-reactive protein (hCRP), IgG, IgM, E. Coli,  and others.

Mediomics collaborates with leading partners in industry and academia to develop applications for its PINCER® platform. Dr. Daren Chen, Professor of Engineering at Washington University in St. Louis, will continue to collaborate with Mediomics on design of a stand-alone detection instrument. Gallus Biopharmaceuticals will assist with testing Mediomics’s new PINCER®-based homogeneous assay system to measure antibody quality. As a preferred CMO provider to Mediomics, Gallus stands ready to assist customers looking for expertise using the technology to expedite new product development.

“The grant will be extremely helpful to move this cheaper, faster screening technology into mainstream applications,” said Mediomics President, Dr. Yie-Hwa Chang. “We expect the availability of the molecular PINCER®-based automated in-process analyzer will displace cumbersome benchtop instruments and gain acceptance for use in biologics production and food pathogen detection.”

About Mediomics LLC: Dr. Yie-Hwa Chang founded the Company in August 2001.  The Company is commercializing core technologies for which it has secured an exclusive license from Saint Louis University, including the following: (i) Bridge-It®, a DNA-binding protein-based bioassay platform, (ii) a related variant – the molecular PINCER®-based homogeneous biosensor and bioassay platforms and companion devices, and (iii) innovative, proprietary methods to screen and develop new high-affinity capture reagents for research, diagnostic and therapeutic use. For additional information, visit the website at www.mediomics.com, or contact Margaret Meng, Chief Administrative Officer, by phone at (314) 971-3028.

About Gallus Biopharmaceuticals: Gallus BioPharmaceuticals is a leading cGMP biologics contract manufacturing company offering exceptional contract services to its clients. The firm, based in St. Louis, MO was established in 2010 and acquired a world-class commercial biopharmaceutical manufacturing facility and workforce from  the  Johnson & Johnson/Centocor division in 2011. In addition to process development and clinical  supply  services,  Gallus  currently  produces  two  commercial  products, Remicade® and Stelera™,  which  are distributed globally.  The St. Louis facility has been approved by every major regulatory body worldwide.    For additional information on biopharmaceutical contract development and manufacturing services, visit www.gallusbiopharma.com, email [email protected], or call directly at (314) 426 – 5000.