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EXACT COVID19 Antibody TEST CLIA-Approved in US Q1-22 – to launch in days
Below is from PatientPop piece - May 15th.
Are you working on any exciting new projects now? How do you think that will help people?
We’re ramping up to launch our EXACT COVID-19 Antibody Test into the US market. We recently received approval from the New York State Department of Health for that product, which clears us to test specimens from anywhere in the United States. By providing semi-quantitative measurements of six distinct antibodies produced in response to exposure to the SARS CoV-2 virus or to COVID-19 vaccination in an at home test, it fills an unmet need to address the new phase we see in this COVID pandemic.
We’re all seeing and experiencing pandemic fatigue as we enter the 6th wave of the pandemic. People are taking off masks in airports and airplanes, social measures to mask and distance are loosening. At the same time, immunity is waning in the general population amidst a lack of uptake on additional boosters so this test launch is coming at a very important time when people will want access to objective, personalized information about their immunity.
We are positioning ourselves to meet demand from employers and individuals alike to measure and track COVID-19 antibodies — as a complement to consultation with individuals’ health care providers. We think the EXACT test will provide a means to observe changes in immunity and general changes to antibody levels across populations. These are the key signals of defense against infection or reinfection from COVID in the long run. Despite of all the changes that are being made socially and politically, testing continues to play an important role in protecting the general population and head off big surges in the emergency departments and hospital ICUs.
At the political level, it’s interesting to us to see that the FDA the CDC resist certain interventions that seem to be suggested by the research. While there is a tide turning in favor of antibody testing, the CDC and FDA appear to have been resistant to it.
The science would tell us that a person’s level of antibodies is linked to their protection against infection. But there seems to be a lack of desire or will at the FDA and the CDC to roll out broad population-based antibody testing and monitoring. Their adoption of another sensible strategy, boosters, demonstrate that they understand waning protection. At the same time, antibody levels can act as the proverbial “canary in the coal mine” for the general waning in protection against infection. Right now, a person has to get infected for us to know that obviously they were no longer protected either through their vaccination or previous COVID infection. This is a big lag, and the opportunity remains to get in front of that lag with big data. There needs to be a will and there needs to be a regulatory pathway to collect the data. I think that is changing, but it’s taken quite a while for those pathways to start to become available.