A Rapid Covid-19 IgM/IgG Serological ... - thermogenesis.com...1| ThermoGenesis...

1 | ThermoGenesis Holdings Inc. (NASDAQ:THMO)

A Rapid Covid-19 IgM/IgG Serological Test for Point-of-Care (04-15-2020)As of April 15, 2020, the above product has been appropriately validated in accordance with Section IV.D. of the “Policy for Diagnostic Tests for Coronavirus disease-2019

during the Public Health Emergency issued by FDA on March 16, 2020”. The required registrations and listings with FDA have been completed for distribution. The product is now listed on FDA website. Visit: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=668984&lpcd=QKO


2 Unmet Needs – No Proven Therapy or Vaccine Exist—— An uncontrolled increase in COVID-19 patients worldwide, 20% will be severe and critical stage

Source: WHO-China Joint Mission, March 2020

Without an effective intervention, ~ 50% of critical stage

patients will die


Critical Needs: Rapid Test + Vaccine + Therapies

– Based on Nature report, more than 60% of all infected cases are transmitted from asymptomatic carriers (https://www.nature.com/articles/d41586-020-00822-x).

– A rapid, affordable test is essential to control the virus and alleviate current testing bottleneck.

3

https://www.nature.com/articles/d41586-020-00822-x


4 Our Response– A Rapid Covid-19 Serological Test

Uncovers anti-covid19 IgM and IgG antibodies Needs only a single drop of blood In less than 5 minutesTests at the point-of-care Expected costs less than $30

§ Simple: no lab equipment required.

§ Easy: fingertip blood sample (same as home glucose test)

§ Fast results: less than 5 minutes to result


CollectUsing the included lancet,1 drop of fingertip blood iscollected.

MixThe specimen is mixedwith the included reagent.

LoadFive drops of the blood/reagentmixture are added to theincluded test cartridge

ResultsTwo minutes later, the result is visualized on the test cartridge.

Control Line

IgM+ Line

IgG+ Line

NegativeResult

IgMPositiveResult

IgGPositiveResult

IgM&

IgGPositiveResult

InvalidResult(no control line)

5 Performing the Test and Interpreting the Results


Detecting anti-Covid19 Ab Response, Not the Virus Per Se 6• Human immune system mounts

an IgM and IgG antibody responsein patients infected withcoronavirus

• IgM and IgG antibodies can be detected in Covid-19 infected patients 0-7 days earlier thanclinical signs and symptomsappear.

• ThermoGenesis Covid-19 IgM/IgG Detection Kit is administered similar to a home diabetic glucose test & can be read within 10minutes.

• If detected in asymptomatic person, it may also mean the person has recovered from mild infection and has developed protective immunity.

Timeline of COVID-19 Infection and Patient’s Immune Response


Triage of Individuals Based on Test Results7Symptomatic Individuals:• Positive result (+): indicates that there is an ongoing COVID-19 infection.

• Negative result (-): indicates that either there is not an ongoing COVID-19 infection or the infection is still inearly phase è Retest with PCR method can rule out viral infection.

Asymptomatic Individuals:• Positive result (+): indicates the person may either be in the early infection stage or may have recovered

from COVID-19 infection è Retest in 14 days, if no symptom has developed, that means the person has recovered.

• Negative result (-): healthy.

Note: All serological tests have false positives and false negatives. In addition, a small number of patients may never develop an antibody response to the virus and, therefore could test negative even with an ongoing viral infection.


8 Validated Performance

Clinical studies (using PCR-positive and -negative patient blood samples) indicate high reliability:

111 of 112 PCR-NEGATIVE PATIENTS TESTED NEGATIVE (99.1% Negative Coincidence Rate)

14 of 14 PCR-POSITIVE PATIENTS TESTED POSITIVE (100% Positive Coincidence Rate)

In additional studies, no cross-reactivity (false positives) was observed in PCR-negative patientsknown to be positive for Influenza A, Influenza B, Adenovirus, Mycoplasma pneumonia, or Respiratory syncytial virus infections.


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• On March 31, 2020, the Company submitted filing in accordance with the “Policy for Diagnostic Test for Coronavirus Disease – 2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturer, and Food and Drug Administration Staff issued on March 16, 2020 for Serological Diagnostics.”

• On April 15, 2020, the Company has received the acknowledgement letter from FDA which provided confirmation that the ThermoGenesis’ SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit has been appropriately validated in accordance with Section IV.D. of the “Policy for Diagnostic Tests for Coronavirus Disease – 2019 during the Public Health Emergency,” issued by FDA on March 16, 2020. The required registrations and listings with FDA have been completed, which now allow the diagnostic kit to be distributed.

• The product is now listed on FDA website. Visit: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=668984&lpcd=QKO

Regulatory Filing Update

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm%3Flid=668984&lpcd=QKO


10 An Immunity Test Can Help People Get Back to Work– Individuals with protective antibodies could be the first group to return to work


Pursuing Excellence for Cell Based TherapiesCell Banking, Cell Process and Cell Therapy

Company Contact: ThermoGenesis Holdings, Inc.Wendy [email protected]

For more information:For ThermoGenesis, visit:www.ThermoGenesis.comFor ImmuneCyte, visit:www.immunecyte.com

Investor Contact: Rx CommunicationsPaula [email protected]

http://www.thermogenesis.com/

http://www.immunecyte.com/

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