Windsor Square-based BiologyWorks Inc. is unique among local Covid testing companies: It’s focusing on markets outside the Unites States.

BiologyWorks has developed a miniaturized test analysis device that allows for quick and relatively inexpensive Covid tests in a clinic setting. But with the U.S. market now focused increasingly on at-home testing, BiologyWorks has instead opted to sell its test device to European countries and soon to other markets around the globe.

BiologyWorks’ Chief Executive Hunt Ramsbottom had previously owned and run manufacturer distribution networks, and when he found out about BiologyWorks, he became an early investor in the company. He was named chief executive a few months later in early 2021. He took time out from his international dealings on behalf of
BiologyWorks to talk with the Business Journal about how BiologyWorks developed its mini test device and the company’s overseas strategy.

How did BiologyWorks develop its miniaturized Covid test lab kit?

It all started with our co-founder Peter Marx, who as a consultant for diagnostic testing companies ran across an influenza testing device being developed at (local late biotech magnate) Alfred Mann’s companies. He was working with them to make the product more affordable. In 2019, after Mann passed, Peter bought the patents and the research for this device and finished developing it.

Just what is this miniaturized test lab kit?

I call it a “lab in a box.” Instead of sending a swab or other sample out to a lab, you can conduct the analysis right there at the point of (sample) collection. The swabs are placed in a cartridge, which is inserted into the analyzer kit. Inside the kit is a technology that analyzes the sample to see if contains influenza or another disease.

The key is that this device can test anything with a molecular background. And it’s portable and quick: Test results come out within 30 minutes. That means it can be used at the point of care — either in a pharmacy or at a mobile clinic that’s visiting villages. It cuts out the entire step of having to send samples out to a lab for analysis.

How much does one of these portable test analysis kits cost?

The test kits are affordable. We can sell our cartridge for $25, while the test kits range anywhere from $50 to $75 per kit. The cartridge is not reusable, but the test kits are.

How did you become involved?

I found out about the company through a long-time friend and associate of mine, Jon Vein, who is another of the co-founders. I immediately sensed the opportunity and invested. By early 2021, I was chief executive.

You led the company’s pivot to Covid testing. But why focus on global markets when there’s such a shortage of quality testing devices here at home?

Several reasons. First, by the time I came on board, this company was already a bit late to the game on the domestic front. And, as 2021 progressed, the focus in this country turned more to developing Covid tests that people could take in their homes — you know, take a swab or other sample and mail it to the lab. But we had a product that was more suited to a clinic setting — and it could give quick results to testing professionals in the field.

Any other reasons?

Yes — the obvious one: 96% of the world’s population lives outside the U.S. And in so many places, there’s a tremendous shortage of clinical labs that can analyze Covid, influenza or other molecular tests. You don’t realize how blessed we are in the U.S. with its abundance of labs until you go tour other countries. Take one country in Africa that I’ll not name: The country has over 40 million people and only 12 labs. It can take a week or more to get test results back in many of these countries. When you’re dealing with a disease like Covid, that’s just too long.

What have been the biggest challenges in penetrating these global markets?

It’s very difficult to get into these markets and, especially, to get approvals from the governments. When you have a new product like this going into these countries, they don’t quite know how to categorize you.

What do you mean? A Covid test is a Covid test, right?

Many countries have different price categories for different types of Covid tests. Antigen tests are at one price level, while (polymerase chain reaction) tests are at another, much higher price level. But ours is a new technology that doesn’t fit neatly into one of these categories. So that has taken time, with a lot of trips back and forth to various government agencies.

What’s the current status of the effort to bring this product to global markets?
We are approved for sale in 18 countries. Six of those are in Europe — we got approvals from those countries first and we now have active sales of thousands of kits total from those countries. We also have a contract with a company in Poland to manufacture the test kits.

So what countries are next?

We are hoping to start selling our kits in Africa by the third quarter. But the interesting thing there is that the kits are not likely to be used for Covid at first. We’re getting approvals now in one country for a tuberculosis test. Right now, it takes 30 days in that country to get TB test results; we can provide the results in less than an hour.

And all the test kits are being made at your plant in Poland?

For now, yes. But this third-party manufacturer that we’re working with in Poland also has a factory in Malaysia, and they are working to retool that factory to accommodate our test kits. That factory should be ready in the next few months.

Do you ever see BiologyWorks selling its test kits here in the U.S.?

Yes, but we’ll have to adapt it to the home testing market. We’re planning on taking a slightly improved product to the next round of FDA approvals. I don’t have an exact time frame yet. But it will involve a home test kit that has sample cartridges for a range of diseases: influenza, strep throat, Covid, etc. … We want a more versatile product for the at-home market while still being one of the most accurate and simplest to use.

Have you seen varying attitudes toward Covid and Covid testing in the countries you are trying to operate in?

What was consistent for us across the countries we’re dealing with — particularly the European Union and Asian countries — is that they take Covid very seriously with more lockdowns that you’ve seen here in the U.S. The countries move a lot faster to either shut down more completely or reopen more quickly. Also, there’s a difference in operations on the ground.

What do you mean?

It gets back to that shortage of molecular analysis labs I referenced earlier. In the U.K., the Covid PCR tests were being shipped to a lab in Ireland. In Italy, even though it has some labs, you couldn’t get Covid PCR test results back for four to five days. This is why in so many of these countries, our lab in a box is a major problem-solver: The lab comes to you.