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ThermoGenesis Distributes FDA Emergency Use Authorized COVID-19 Antibody Test Kit. What Does it Mean?

ThermoGenesis recently announced it has entered into a supply agreement with Biohit Healthcare to distribute its COVID-19 Antibody Test Kit. This agreement is significant because  Biohit Healthcare has already received Emergency Use Authorization from the U.S. Food and Drug Administration.

 

What is Emergency Use Authorization?

The U.S. Food and Drug Administration (FDA) plays an essential role in evaluating whether medical products, such as drugs, diagnostic tests and other medical devices are safe, effective and fit for distribution. However, in the case of a public health emergency, like the current COVID-19 pandemic, there may be an urgent need for products to diagnose, treat or prevent a medical threat and not enough time for the FDA to conduct the full, rigorous approval process. 


To help expedite the approval process and provide more timely access to life-saving medical products, the FDA can issue what is known as an Emergency Use Authorization (EUA). According to section 564 of the Federal Food, Drug, and Cosmetic Act, the EUA process allows for, “unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases.”

 

 

Understanding that their normal approval process can cause an unnecessary bottleneck in times of crisis, the EUA is a tool the FDA has put in place that allows millions of people access to medical products when they are most needed. It is important to note that simply because the approval process is faster, does not mean the products that receive EUA designation are inferior or somehow less effective. The FDA still stringently evaluates every product using the evidence that is available and carefully balances any known or potential risks with the potential benefits. The EUA process, while expedited, still can take weeks or even months and not every product will receive final authorization.

 

What Does EUA Mean for ThermoGenesis?

Partnering with Biohit Healthcare allows ThermoGenesis to offer a COVID-19 IgG/IgM antibody test kit that has already gone through the process and received its EUA. This authorization will make the test easier to distribute to a broader range of labs and medical professionals. Prior to partnering with Biohit Healthcare, ThermoGenesis was only given permission by the FDA to distribute their COVID-19 antibody test kit to CLIA-certified laboratory facilities to perform high complexity testing, or tests that require laboratory expertise beyond normal automation to perform. With the addition of an EUA authorized test kit, ThermoGenesis can now expand their reach to include moderate complexity labs as well. This is the next step in the organizations’ ongoing commitment to advance the role of antibody testing and increase the supply and availability of these tests. 

With the ultimate goal being to provide antibody tests directly to point of care facilities such as hospitals, urgent care clinics and general practitioner’s offices, this partnership brings ThermoGenesis one step closer to achieving just that. 

 

What Does This Antibody Test Mean for ThermoGenesis?

ThermoGenesis will now be able to deliver a high quality IgG/IgM antibody test in large quantities to help healthcare systems around the world better manage the current health crisis. This new partnership allows the organization to reach a broader market share with a lower price point than they were able to before. 

Boasting a high combined sensitivity of 96.7 percent and a combined specificity of 95 percent, the test has been proven to be effective in accurately providing an IgG/IgM antibody detection. An inexpensive, reliable, rapid serology test is a critical tool as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2 and that is what ThermoGenesis is here to provide. ThermoGenesis believes this test can meaningfully contribute to the pandemic response and eventually play a part in the reopening of schools and the overall economy.

 

How ThermoGenesis Can Help

ThermoGenesis Holdings, Inc. (formerly Cesca Therapeutics Inc.), is a pioneer and market leader in the development and commercialization of automated cell processing technologies for the cell and gene therapy fields. They market a full suite of solutions for automated clinical biobanking, COVID-19 antibody testing, point-of-care applications and large-scale cell processing and manufacturing with a special emphasis on the emerging CAR T immunotherapy market. The company is committed to making the world a healthier place by creating innovative health solutions for everyone. 

This COVID-19 antibody test is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of in-vitro diagnostic procedures. If you’re a healthcare professional looking for more information on how to buy their COVID-19 IgG/IgM antibody testing kit, visit their website and request a quote today.

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