Diocheck™ Frequently Asked Questions
1. Who is Diomics?
Diomics Corporation is a biotechnology company focused on science-based innovation and the development of life-improving products. Our proprietary Diomat™ technology platform is optimized for the collection and delivery of compounds and proteins and can also be used for drug delivery, long-term monitoring, diagnostics and production of life-saving hormones and other bio-compounds. Based in San Diego, California, Diomics has developed numerous products, tools and services for the molecular, diagnostic and forensic industries.
2. What is Diomat?
Diomat is a proprietary bioresorbable material manufactured from an FDA-approved synthetic biopolymer that is commonly used in tissue growth, rhinoplasty, wound care and other procedures. It can be formed into a variety of shapes and sizes, from nano-sized beads for delivering antibodies or drug therapy, to films and gauzes, swabs and even 3D printed shapes. Key to the Diomat material differentiation is an extreme level of hydrophilicity that is uniquely suited to bind compounds, proteins and antibodies to a specific material form factor allowing for a time-release capability with controlled release of the compound, protein or antibody over time.
3. What is Diocheck™?
Using Diomics’ proprietary, FDA-approved material Diomat™, a bioresorbable polymer, Diocheck detects and reports within 24 to 36 hours whether a person has developed an immune response to SARS-CoV-2, the virus that causes COVID-19. A positive response causes a change in skin color that is visible through the Diocheck skin patch. Diocheck is also being developed as an intradermal product using nano-sized beads of the same biopolymer to detect and visually report the formation of an immune response, potentially for up to one year, before being safely absorbed by the body.
4. How does Diocheck work?
Diocheck is a modernized version of the 100-year-old tuberculosis test in which the presence of a SARS-CoV-2 antigen coupled to the Diomat material provides an easily seen visual indication of an immune response to the virus. The patch delivers a localized dose of non-infectious antigen, which is absorbed through the skin. A reddening of the skin visible through the patch indicates that the person has either recently been exposed to the virus and should get tested and quarantine, or has recovered from a previous coronavirus infection and may still retain immunity. The patch begins to detect an immune response within 24 to 36 hours of application and is expected to effectively monitor for up to 14 days.
5. Why would someone use Diocheck?
The Diocheck patch answers one of the biggest roadblocks to halting the spread of COVID-19—a simple, universal way for people to continually monitor their own immune status over an extended period of time. Until there’s an effective vaccine in widespread use, large populations can use the patch to monitor themselves and know quickly if they have been exposed to the virus and need to get tested and take precautions to avoid infecting others.
When a vaccine for SARS-CoV-2 becomes available, the Diocheck patch could also be used to monitor the critical gap from when a person receives a vaccine and when the body forms the expected level of protective immune response, which current reports suggest could take several weeks. It could signal as well when the immune response stimulated by a vaccine has declined, indicating that the person needs a booster.
6. What is the status of your clinical trials?
Diocheck is entering pre-clinical animal studies studies under the guidance of Jonathan R.T. Lakey, Ph.D., M.S.M., Professor of Surgery and Biomedical Engineering at the University of California, Irvine. Human clinical trials are expected to begin in December 2020.
7. How long will Diocheck last?
The Diocheck transdermal patch is expected to be effective for up to 14 days. The intradermal Mantoux-type version of Diocheck is expected to effectively monitor for the presence of an immune response for up to 1 year.
8. Will the patch be available over the counter?
Commercialization of the patch is currently being explored. Availability for OTC will depend on FDA approval.
9. How much will the Diocheck patch cost?
Our goal is to ensure that the patch is as widely accessible as possible, so we’re laser-focused on creating efficient, cost-effective manufacturing and distribution strategies and pricing that respond not just to the demands of the marketplace but to the broader needs of society as well.
10. Will either the patch or intradermal format be covered by Medicare/Medicaid/private insurance?
That’s something we’ll be looking at very carefully, but right now it’s too soon to say with any certainty.
11. How and where will Diocheck be manufactured?
We expect that Diocheck will be locally manufactured in each of the territories around the world in which it will be sold.
12. How do you plan to market and distribute Diocheck?
We are working hard to make Diocheck as easily available as local regulatory requirements allow in each country where it will be sold.