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Friday, 07/31/2020 6:34:36 PM

Friday, July 31, 2020 6:34:36 PM

Post# of 27112
Sales in the First Quarter 2020 continued to be negatively impacted by the price competitiveness in the core markets (government, employment and clinical) where we sell our drug of abuse tests. In addition to price competition, in the very latter part of the First Quarter 2020, sales were also negatively impacted by the Covid-19 pandemic. Late in the First Quarter of 2020, we began marketing a Rapid Test to detect Covid-19 antibodies in whole blood, serum or plasma. The test, manufactured by Healgen Scientific, LLC is being marketed in full compliance with the March 16, 2020 Emergency Use Authorization (“EUA”) policy set forth by the FDA and in accordance with an EUA issued by FDA on May 29, 2020. Due to specific regulatory events that occurred from March 2020 until May 2020, we did not record any sales of Covid-19 tests, although we did take pre-orders (with payments) for Covid-19 tests.

 

In addition to the Covid-19 rapid antibody tests, we have brought on new products and service offerings to diversify our revenue stream through third party relationships; one of which is a lower-cost alternative for onsite drug testing and, point of care products for certain infectious diseases. With the exception of the lower-cost drug test alternative, (and Covid-19 rapid antibody tests sold subsequent to the First Quarter 2020), these new offering have yet to materially positively impact sales. In the year ended December 31, 2019, we expanded our contract manufacturing operations with two (2) new customers. Beginning in mid-2019, we can sell oral fluid drugs tests in the employment and insurance markets under a limited exemption set forth by the FDA. Prior to this point, we could only sell our oral fluid drug tests in the forensic market in the United States and to markets outside the United States. We are hopeful that gaining access to this market again will enable us to see revenue growth for our oral fluid drug tests in the future; however, we are uncertain when in the year ended December 31, 2020 we could start seeing significant sales in the employment market given the current global health crises and Covid-19.