An Insider Look: The PTS Diagnostics SARS-CoV-2 Antibody Test

The PTS Diagnostics SARS-CoV-2 Antibody test

In the midst of the COVID-19 global pandemic, medical companies worldwide are racing to develop solutions that will assist in the battle to treat those affected by this virus. As healthcare workers spend countless hours fighting against the novel coronavirus, PTS Diagnostics and our parent company, Sinocare, are also actively joining in that fight.

Never before has there been a concerted effort between Sinocare and PTS Diagnostics quite like this one with such a  high degree of priority, visibility, and such a tight timeline.” said, Mark Duncan, Director of Global Product Management and the project manager for the launch of the new SARS-CoV-2 antibody test. We recently sat down virtually with Mark to discuss the recent efforts being made between Changsha, China and Whitestown, Indiana.

Q: What are the key functions of the SARS-CoV-2 test that we will be manufacturing and selling?

A: The PTS Diagnostics SARS-CoV-2 Antibody Test detects both types of antibodies (IgM and IgG) that develop after a SARS-CoV-2 infection, allowing healthcare organizations and professionals to identify individuals previously infected with SARS-CoV-2.

We are currently seeking clearance to sell this combined antibody test as a “rapid fingerstick test” meaning that by using a small, 10 µL, blood sample obtained from a fingerstick, results can be obtained in 15-20 minutes.

Q: What are the key functions of the SARS-CoV-2 test that we will be manufacturing and selling?

A: The PTS Diagnostics SARS-CoV-2 Antibody Test detects both types of antibodies (IgM and IgG) that develop after a SARS-CoV-2 infection, allowing healthcare organizations and professionals to identify individuals previously infected with SARS-CoV-2.

We are currently seeking clearance to sell this combined antibody test as a “rapid fingerstick test” meaning that by using a small, 10 µL, blood sample obtained from a fingerstick, results can be obtained in 15-20 minutes.

Q: We have heard about many antibody tests coming to market. What makes ours stand apart?

A: Many companies have raced to be the first to market and are now facing criticism over performance issues. There are also concerns about “knock off tests” and products that use unsubstantiated claims.

What makes our test stand apart is that we took the appropriate steps in reviewing Sinocare’s data and running our own studies to ensure the product meets the performance requirements that our customers expect. We have data from a recent study performed in a partnership with IU Health that further validates the clinical study data Sinocare originally performed.

Q: How have PTS and Sinocare been working together and sharing roles for this product launch?

A: What makes this undertaking unique, is that there is a very large team made up of people from both PTS Diagnostics and Sinocare who are all working together to complete this in an abnormally short span of time.

Each team members’ roles are vital leading up to what will be, a monumental success story in our company’s history.

Between both organizations, there are identified team members who share similar roles and act as key contacts or designated counterparts. This allows for the free flow of information between both companies by having access to subject matter experts from both PTS Diagnostics and Sinocare. It also assists with language barriers, time zone challenges, and other nuances. This team has worked tirelessly together, meeting several times a week (many times outside of “working hours”) to meet the deadlines for this project.

This project has evolved in many ways over the past serval months and the team has remained flexible, incorporating work from previous stages into each new phase.

In order to bring this new product to market, many hands are working together. Several of these tasks include translating technical documents from Mandarin to English, creating incoming inspections and work instructions, reviewing stability studies and risk analyses, putting together the necessary paperwork for FDA submissions, and developing marketing materials to support the sale of the product.

Q: How do you see the SARS-CoV-2 test integrating into our current portfolio of point-of-care products? A: Populations of people most at-risk for developing complications related to COVID-19 include those living with comorbidities such as diabetes and cardiovascular disease. Therefore, there is a direct connection between our current A1CNow®+ and CardioChek® product lines and this new antibody test. Healthcare providers and patients who treat and seek treatment for these comorbidities may also need to be assessed for COVID-19 antibodies. Our antibody test could be used in conjunction with our current products, especially if the coronavirus becomes a seasonal disease. This test could also fit particularly well within our health and wellness event verticals.

Q: Given everything that you have shared about this developing product launch, what has made you most proud to lead this project?

A: Outside of the FDA remediation, which remains our organization’s highest priority, team members who were identified to work on the SARS-CoV-2 test project instantly banded together to work through unknowns and took accountability to solve problems independently.

It cannot go without saying that during this time we were all working remotely in our various independent locations. Seeing each person take on what they are responsible for to move the project forward during this unparalleled time has been incredibly rewarding. The global impact that this new SARS-CoV-2 test has the potential to make is very clear to all team members contributing to this initiative.  

It is certain that this period in time will change and impact all of us in one way or another due to the COVID-19 pandemic. Having the opportunity to work on a project that will directly affect large, diverse populations of people in relation to combating the spread of this virus makes you intrinsically motivated to “do good.”

Kelley McClain

Senior Marketing Manager

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