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Yale 62

Classmate Participates in COVID-19 Test Kit Project

By Ken Merkey

Typical PCR Diagnosis machine

[Editor’s Note: Ken Merkey (Hilton Head, SC) contacted Yale62.org because he thought classmates might be interested in his unexpected recent business involvement in COVID-19 testing and test kits. Thanks, Ken. Four senior Public Health officials testified virtually before the Senate Oversight Committee May 12 and emphasized the importance of greatly increasing testing in the United States as part of the effort to restore citizen confidence and support efforts to reopen the economy. Meanwhile, there are reports of new outbreaks of the disease in China, South Korea, Germany, all of whom had earlier been quite successful in limiting the rapid spread of the disease. These nations immediately re-instituted extensive testing and contact tracing programs intended to test millions of citizens, isolate those who tested positive and pursue contact tracing for new cases.]

I had never been involved in big pharma or the worldwide medical supply chain. A company that I am affiliated with, a hospitality company, has been doing business in South Korea for over 30 years. Early this year, my guys asked me whether we could help distribute Korean COVID-19 test kits in the USA. The Koreans took an early lead in COVID-19 prevention and testing. We decided that it was sort of our duty to contribute what we could to the pandemic solution. We quickly learned that we were very small fish in a very big pond dominated by a bunch of really big (e.g., “ugly”) guys that controlled the market.

Typical optical reaction plate for the PCR machine

On one hand, I still am just like the everyone else in Yale ’62, nearing 80 years of age and aware and concerned that the virus is of greater risk to people our age. On the other, I am now involved, in a small way, trying to help import and market better, quicker and lower-priced testing methods, which seem to be sorely still needed in our country and elsewhere.

So here’s where we stand (from my perspective), as of mid-May, 2020, in the fast-changing world of COVID-19 testing:

We discovered that most of the test kits on the market today, including many from South Korea, require analysis in a laboratory that is equipped with a PCR (polymerase chain reaction) diagnostic machine. These machines are expensive and are not now in stock anywhere in the USA or Korea. A PCR machine is primarily used in large research labs. They are not commonly installed in smaller labs and clinics. Consequently, in most instances, the test specimens must be sent to a remote lab for testing. The average cost is $150/analysis and it takes 2 to 3 days for a response.

Examples of the reagent supplied with most test kits

There’s a Korean vendor of COVID-19 test kits who can also can supply the diagnostic equipment in a package deal. The diagnostic equipment is unique to their reagents. This company is presently awaiting Emergency Use Approval (EUA) from our US FDA in order to distribute them in the USA. In Korea, this company has equipped mobile labs that can drive to any facility that requires testing. Test results are available on site in 30 minutes.

Another option is a rapid test kit very similar to a pregnancy test. A drop of blood, taken from a finger prick, is put on an analysis tab. Within 15 minutes, the test will give a yes or no as to whether the patient has the IgG and IgM antibodies to 2019 Novel Coronavirus in their blood, serum or plasma. If positive, further testing is required. As the vast majority of employees or members will test negative, this approach uses a much less expensive test to rule out those large numbers that are not positive. Until recently, the manufacturer was allowed to sell the kits over-the-counter. However, recently, the FDA decided that, since it is a COVID-19 test, it is subject to FDA review. An EUA is expected by the end of May to allow distribution.

Ken in Utah

Now, the awkward part. In my haste (and zeal) to conquer the learning curve ASAP, I contacted two professors at the Yale School of Medicine, both of whom had authored papers on COVID-19 testing. They provided no help whatsoever. So much for Lux et Veritas.

So, today we are standing by, waiting for the US FDA to issue EUAs to our manufacturers so that we can start distributing the products. For years and years, I told anyone that knew me or would listen that I never wanted to stop working. That remains true, but I must admit that I never envisioned involvement in a situation and opportunity such as distributing COVID-19 test kits.

On a separate but equally important issue, we are hoping that a vaccine will get the fast track for development. Testing is only part of the solution; until we have a vaccine, we will never really be free of risk. Hopefully Yale, which is very active in all of this research and testing, also will be able to contribute to that effort.

We welcome your comments, below.

6 comments to Classmate Participates in COVID-19 Test Kit Project

  • Ken Merkey

    I have had some feedback from Yale. As it turns out, Yale and the YSM have historically focused on microbial pathogenic and immunology research. Vaccine development has not been their strong point. I am surprised that these disciplines are not fungible and transformable into a major effort during this pandemic.

  • Ken Merkey

    Roman,

    Thanks for the insight. Again, this is a world foreign to me. It must be a daunting task to manage an 11,000 person school. Getting them to focus on one major issue, the pandemic and a vaccine to end it (not more articles), is probably not possible. YSM comes across as a behemoth, waddling through life hoping to find a promised fruit from time-to-time. As to writing op-eds, that requires a level of expertise that I do not have.

  • Roman L Weil

    About those two Yale professors who’d not give you the time of day: I’m writing as a Professor Emeritus, who’s had tenure for fifty years. I’ll guess those guys don’t and are breaking their asses to get it. The current issue of The Economist magazine reports that by the end of the first week of May, over 7,000 academic articles had been published on aspects of the pandemic, more than half peer reviewed. Those two guys are shouting to be heard in the cacophony of that published work–doing their best to get their own work noticed, published, haled and revered. They don’t have time to be pestered by an 80-year-old businessman who has an idea for a device that might save lives. That’s not going to lead them to their promised land, where the gate-keepers say, “Publish or Perish.” Did you try Scott Gottlieb? He seems to have a broad audience. I’ll guess it’s hard to get his attention, however.

    Have you written an op-ed about the devices and sent it to the press?

  • Ken Merkey

    Neal and Bill,
    Thanks for the encouragement. The task at hand is somewhat daunting, especially for a guy with no experience in this area. We did get a glimmer of hope (I think) from the FDA. They sent a letter to one of our competitors stating that rapid test kits can be sold prior to an EUA as long as appropriate cautionary disclaimers are included. The problem with rapid test kits is the accuracy. For large employers it does provide a less expensive, first level test, especially if they need to do it daily.

  • Neal Freeman

    Kudos to you, Ken. I know what you mean about YSM. But on the hopeful-news front: I was in DC last week and the FDA is new and different and fully engaged. The governing metaphor there, until five minutes ago, was thalidomide — all caution, all the time. Now, it’s “Get the Hell out of the way!”

    Keep on keepin’ on.

  • Bill McGlashan

    Hang in there, Ken — even the slow-moving FDA can increase speed if the need is great. As you point out, the need is very great, so uplifting to read of your response to the pandemic.

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