Editor’s note: This story was published in mid-April and terminology, rules and guidelines surrounding testing and test kits and the like have been revised and updated in some cases. This story does not reflect any changes.
By LYNETTE HAALAND, Four Points News
Shane Stevens has been in discussions about COVID-19 testing with the White House, the FDA, military officials and many other leaders locally and across the nation over the past several weeks.
Stevens, a resident of Steiner Ranch and CEO of AnyPlace MD, has 1.2 million coronavirus test kits being shipped this week to add to the 60,000+ kits he has already received.
Plans are to distribute the kits nationwide to get more people tested in the days ahead.
“Military has bought some, some counties, some private hospitals/clinics and one large employer is looking at purchasing from us,” Stevens said.
He hopes these kits can help with so many who need testing for the coronavirus — either for their own reassurance or to show their employer they are virus free.
The 15-minute test, which is done by using blood from a finger prick, has to be done with a medical provider or in conjunction with a telehealth visit and a telehealth extender, the people actually administering the tests. The latter scenario is especially helpful in these days of social distancing.
Earlier this month on April 4, AnyPlace MD teamed up with MD Box (a platform for people to meet with a doctor virtually) to host a telemedicine drive-through in River Place. Stevens thinks it was the world’s first such event.
The charge for the test was $39, well below the average price of $79 for a telehealth visit.
“I just heard so many neighbors worried about whether or not they had it so I wanted to do something with our community,” Stevens said.
“We are presently planning a large outdoor drive-through telehealth
clinic and are promoting an indoor drive-through telehealth model which can be
used in large arenas,” he added.
Stevens admits that being at the forefront of this pandemic with a helpful testing tool is exciting. He shares how this venture came about in a Four Points News Q&A.
- How did this come about?
We had been researching for a while how to start testing within our platform for COVID-19. A few folks within the organizations figured out the solution to utilize serologic (finger prick blood test) 15 minute lateral flow tests as they had used in Singapore to effectively fight the virus and help people stay at work.
These tests were ordered as early as February to start validating. Since then it has been 16 to 20 hour days communicating with top federal, state, county officials as well as top level military personnel.
We saw a ton of resistance up front just due to a lack of knowledge and perhaps an optimism that we, as a country, would not be hit as hard as other countries.
Today, you see everyone saying we need serologic tests to get the U.S. back to work as we have 1.2 million tests scheduled to arrive in the U.S. prior to April 25.
I received one of the highest compliments I could possibly receive on Easter Sunday. One of our top U.S. military leaders said, “I know you know this but your
company is the tip of the spear and is at the cutting edge of what needs to be
- Can you share more about this model of delivery, can you tell us about the process?
It was designed to mitigate personal interaction and further the spread of the disease. Simple concept, keep infected people away from uninfected people and vice versa.
In war, we have to keep our best fighters safe. In this fight, some of our best fighters are our medical providers. This model applies telehealth and a trained telehealth extender to support in completion of the test and use of the telehealth app.
It is not as “socially distant” as completing this test in home in conjunction with a telehealth visit but it is as close as we can get due to current laws and regulations.
Plus it puts dentists, audiologists and other professionals in medical related fields back to work as telehealth extenders.
I don’t think anywhere except New York is ready for our next delivery models quite yet but unfortunately, they may be soon.
- How did you have the foresight to see this coming and have a solution?
Frankly, we didn’t. MDBox platform was chosen as our teaming partner in pursuing government contracts based on superiority over other platforms and specifically the AI they have built which can read a urine test or lateral flow test to eventually show results of over 3,400 diseases. The AI reads and interprets it, and the telehealth doctor reviews, validates and diagnoses it.
4) How were you able to see a need and within a very short period of time bring testing to the consumer?
We obviously saw the need on a broad scale for our country a long time ago. Frankly, if I have to get to the underlying how, I would say it was a miracle. I have seen so many things happen which are above the capability of any one person that there is no way we would be here without God’s guidance.
5) We understand the FDA has not approved the serology tests you are using. When do you anticipate FDA approval?
The FDA (Food and Drug Administration) has indicated it does not intend to object to the use of serology tests. So long as the tests are validated (which our manufactures do and our biologist here does) and so long as each overseas
manufacturer notifies the FDA of their intent to distribute these tests and the FDA provides affirmation that they are able to distribute.
My interpretation of this is they understand what the tests do and are good with them being distributed/used but there are multiple manufacturers of these tests and under the current circumstances, they are not going to take the time to do a deep, time-intensive amount of reviewing on each and every one. Therefore the full FDA review/approval/authorization is not necessary for these tests at this point.
6) How have these tests and your model processes been received?
Initially with a lot of skepticism. I’ve had so many texts with so many people about how this can benefit our cities, counties, state and nation and it has been hard to get through. Dr. Birx (Coronavirus Response Coordinator for the Trump Administration’s White House Coronavirus Task Force) has been one of the proponents of serology testing and newer models from the beginning.
On April 11, Governor Cuomo stated he wants to consider a possible plan to roll out in home testing in New York. Also on April 11, our president stated he wants to see wider use of testing via serology tests.
So in four weeks now, we have come a long way and it is bitter sweet. While it is good to receive validation, it is also sad to see that my fears of where this was heading was right.
7) How many tests do you have available?
We only have 20,000 remaining and we have 1.2 million coming in. We are buying all of the supply we can from the manufacturers but we are really buying future production. There is no existing supply sitting in a warehouse waiting to be purchased. We have first right to distribute here in the U.S. from two of the approved lines but we need PO’s and commitments to continue purchasing more.
8) Where can people find out more information about COVID-19 testing?