Mediomics, LLC Earns ISO 9001 Certification



St. Louis, Missouri – October 30, 2015 – Mediomics, LLC, a St. Louis based innovator and manufacturer of assay kits and biosensors for physicians, hospitals, laboratories and other organizations in the medical field, recently received ISO 9001:2008 certification from the International Organization for Standardization (ISO).

To receive ISO 9001:2008 certification, Mediomics, LLC had to meet a set of comprehensive quality system requirements and pass an independent third party audit.

“This is like a doctor passing the medical boards or a lawyer passing the bar exam,” said, Dr. Yie-Hwa Chang company Founder and President.  “And, we are very proud of the way our staff performed during the preparation and audit process,” he continued. “The company has been in business since 2001 and we see this achievement as a major step in maintaining our business position and product quality in support of our customers.” said Dr. Chang

“With the new ISO certification, we expect to continue our growth and enter new markets where such a registration represents part of the criteria for consideration,” Dr. Chang added.

ISO 9001:2008 certification helps both product and service oriented organizations achieve standards of quality that are recognized and respected throughout the world.

Mediomics LLC’s patented technology provides the quick detection of biomolecules, which will revolutionize the ability of medical facilities and physician’s offices to do onsite testing for their patients faster and more cost effectively.

These quick and simple test kits are used to quantify many biologically and therapeutically important macromolecules, including DNA, biomarkers, hormones, antibodies, intracellular signaling molecules, protein-protein complexes, bacteria, fungi and viruses.

In simplest terms, Mediomics’ technologies can do a wide variety of common medical tests faster and cheaper than conventional testing methods.

To date, Mediomics, LLC has received $5.6 million in highly competitive SBIR/STTR Phase I/II grants from the National Science Foundation, the National Institutes of Health and the Department of Defense. The company is located in a 4,500 SQ’ facility equipped with state-of-the-art research and production equipment.

During the certification process, Missouri Enterprise ISO experts provided Mediomics, LLC, with training, documentation preparation and implementation assistance, auditing support and on-site support.


For More Information, Contact:

Harold Zinn, Vice President

Corporate Communications

314-434-6300 ext 1301

314-971-1837 (mobile)

[email protected]

Mediomics, LLC Receives Phase II SBIR Contract: Awarded $969,770 to develop high affinity antibodies for site-specific detection of protein O-glycosylation

Mediomics, LLC Receives Phase II SBIR Contract: Awarded $969,770 to develop high affinity antibodies for site-specific detection of protein O-glycosylation



Mediomics, LLC has been awarded a $969,770 Phase II SBIR contract (HHSN261201300047C) from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services. After successful completion of Phase I research, this project aims to develop a panel of high affinity scFvs for the detection of O-GlcNAc modified proteins. Using Mediomics’ innovative molecular PINCER® platform, Mediomics will develop the most effective methods to quickly screen for high affinity monoclonal antibodies to detect important post-translation modifications of proteins.

Mediomics provides innovative assay kits, biosensors, and multiplexed assays 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. The in vitro diagnostics market is expected to reach $74.46 billion by 2020, which demonstrates a steady growth from an anticipated value of $69.1 billion in 2017 and its estimated value of $51 billion in 2010.

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, L-Methionine, PDE, biotin, human insulin, human albumin, human C-reactive protein (hCRP), IgG, IgM, E. coli, and others.

In addition, Mediomics has also received an SBIR Phase II contract (200-2012-52857) from the CDC to develop robust and cost-effective homogeneous assays for quick detection of HCV infection, and an SBIR Phase II contract (HHSN261201200081C) from National Cancer Institute to develop a fully automated in-process bioanalyzer to detect the titer of protein drugs during their production.

About Mediomics, LLC:

Mediomics is a St. Louis based Biotech company. 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, multiplexed platform, (ii) a related variant – the molecular PINCER®-based homogeneous biosensor, bioassay, multiplexed assay platforms and companion devices, and (iii) innovative, proprietary methods to screen and develop new high-affinity capture reagents for research, diagnostic, and therapeutic use.