ThermoGenesis Holdings, Inc. (NASDAQ:THMO) Q1 2020 Earnings Conference Call - Final Transcript
May 14, 2020 • 04:30 pm ET
which allows for automated processing of our autologous peripheral blood and bone marrow derived stem cells at the point-of-care locations such as surgical centers or clinics. It also allows isolation of different cell fractions from the breath simultaneously. For example, the simultaneous isolation of convalescent plasma and immune cells.
The robust product line with a strong focus in the cell gene therapy has positioned ThermoGenesis as the market leader for cell banking and cell therapy, which will sustain our growth beyond this COVID-19 pandemic. As you all well know the word COVID-19 pandemic has now affected more than 200 countries and regions, resulting over 1.4 million reported cases and more than 85,000 deaths in the United States alone.
The disease has spread rapidly causing a tremendous impact on the US healthcare system and leading to immense societal disruption. The public health threat posed by COVID-19 remains extremely high, both in the US and globally.
In order to respond to the challenges imposed by this global pandemic, during the first quarter of 2020, working together with our joint venture partner, ImmuneCyte, we began mobilizing our expertise and global resources in the medical technology field to develop a systemic approach and strategy to fight against COVID-19 virus.
On March 31, we submitted notification to US Food and Drug Administration or FDA with the intention to register and market the COVID-19 IgG/IgM antibody fast detection kit, In accordance to the Section 4, Part D of the policy for diagnostic test for Coronavirus disease-2019 during the public health emergency issued by FDA on March 16, 2020, in short the Policy D. The test where hereby refers to as the rapid antibody test below.
On April 15, the company received an acknowledge letter from FDA confirming that the ThermoGenesis COVID-19 rapid antibody test has been appropriately validated for distribution under the Policy D guideline. As of May, the company has already started to ship out our rapid antibody test to fill pre-orders and incoming orders.
Additionally, we have also completed submission of additional information to the FDA, requiring the views of the COVID-19 rapid antibody test under the Emergency Use Authorization pathway and we are still awaiting for the agency's response.
The rapid antibody test is designed to uncover anti-COVID-19 IgM/IgG antibody using a single droplet of blood and can deliver results in under 10 minutes at an expected cost for less than $30. If the entire nation has to be tested, then we estimate that over 330 million tests could be needed in the US alone and global demands continue to increase. We currently have manufacturing capacity to produce 100,000 tests per day and can scale up manufacturing to three times that amount, if needed.
The COVID-19 rapid antibody test detaches the antibody in patients in response to COVID-19 infection. The test can be used for pre-screening for COVID-19 patients and also for identification of individuals who have encountered virus in the past and developed an antibody response.
The antibody response is part of