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Innovative Pediatric Solutions

Dedicated to enriching children's lives, Medosome Biotec is committed to developing and commercializing cutting-edge technologies addressing pediatric diseases. We specialize in early-stage technologies for rare and tropical pediatric diseases, emphasizing precision medicine principles. Our focus extends to genetic tests for rare diseases and personalized dosing of pharmaceutical drugs.

Pioneers in Early-Stage Technologies

Medosome Biotec specializes in early-stage technologies, navigating from late discovery through the critical phases of IND/Phase I. With a blend of scientific expertise and entrepreneurial acumen, we drive innovation and streamline commercialization processes.

Precision

Medicine Focus

At Medosome Biotec, our primary focus lies in developing next-generation technologies within the realm of precision medicine. With a dedicated emphasis, we specialize in creating and providing genetic tests for diagnosing rare diseases and delivering personalized dosing of pharmaceutical drugs.

For more information on Precision Medicine and Medosome Biotecs projects click the button below.

The NIH estimates that 25-30 million Americans, or about 1 in 10, suffer from a rare disease. All told, there are about 7,000 rare diseases. Some 80% of the rare diseases involve a genetic component.

Precision medicine takes into account individual variability in genes, environment, and lifestyle for each person. Using this approach doctors and researchers predict more accurately which treatment and prevention strategies for a particular disease will work for each individual (i.e. the right treatment, for the right patient, at the right time) as opposed to a one-size-fits-all approach. A component of precision medicine is “companion diagnostics”, which is defined by the FDA as an in vitro diagnostic (IVD), which provides information that is essential for the safe and effective use of a corresponding drug or biological product.

Companion diagnostics can: identify patients who are most likely to benefit from a particular therapeutic product; identify patients likely to be at increased risk for serious side effects as a result of treatment with a particular therapeutic product, or; monitor response to treatment with a particular therapeutic product for the purpose of adjusting treatment to achieve improved safety or effectiveness.

For more information on Medosome Biotec’s companion diagnostics and Laboratory Developed Tests (LDTs) please click the button below.

  • GSTZ1 haplotyping for the accurate dosing of dichloroacetate (DCA):  DCA is a small molecule that has therapeutic potential in treating a number of rare and common diseases. One limitation of DCA is that the drug is potentially neurotoxic, although the extent of toxicity varies in the patient population. The human glutathione transferase zeta 1 (GSTZ1) gene encodes a protein that dehalogenates DCA to inactive glyoxylate. Members of our research team discovered that haplotype variations in the human glutathione transferase zeta 1 (GSTZ1) gene influence the kinetics of DCA, distinguishing “fast” and “slow” drug metabolizers thus explaining the varied response in the patient population. Using this test, patients are dose stratified to receive “high” or “low” dosage based on the results of their GSTZ1 haplotyping test.
  • A genetic test for determining HIV and HCV subpopulations for personalized dosing with antiretroviral drugs. HIV and HCV are serious diseases for pediatric and adult populations particularly in developing countries. Treatment of HIV and HCV has focused on managing the patient’s viral population with antiretroviral drugs. Minor drug resistant variants that are not detectable in standard commercial assays are known to compromise the patient’s response to drug therapy. We developed a highly sensitive assay using NextGen sequencing for detecting subpopulations of HIV and HCV in infected patients upon which a drug and dosage regimen can be prescribed.

Key Role of Genetic Testing Laboratory

Central to our future development is our CLIA certified (# 10D2114863), CAP accredited (# 9456065) clinical genetic testing laboratory. CAP-accredited laboratories must adhere to rigorous regulatory requirements to achieve accreditation, which is considered the “gold standard” in laboratory accreditation. This facility serves as a cornerstone for our endeavors, enabling us to advance our precision medicine initiatives effectively.

Expanding Reach and Opportunities

While our primary efforts are directed toward the pediatric marketplace, we actively seek opportunities in the broader drug and genetic testing sectors. We pursue ventures that complement or extend from our pediatric products and technologies.

Commitment

to Intellectual Property Protection

Medosome Biotec is committed to safeguarding our innovations. We vigorously pursue patent protection and regulatory exclusivity for our products, ensuring their integrity and market competitiveness.

Connect With Us

For questions or collaborations, feel free to contact us. We welcome opportunities to contribute to pediatric healthcare advancements.

Meet Our Team

Small but mighty Medosome Biotec has a dedicated team of highly trained scientists and business professionals. Additionally, we utilize numerous consultants, academicians, CROs and CMOs for accomplishing specific tasks.

Richard E Wagner President and CEO

I have a very diverse background which includes both academic and business experiences. I am driven by an insatiable desire to learn and develop useful products to make the world a better place. I am deeply concerned and committed to addressing inequities in healthcare, particularly for children. My academic credentials include a Ph.D. degree from the University of Illinois, and M.S. and B.S. degrees from Rutgers University. Additionally, I am a registered patent agent with the USPTO.

[email protected]

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