Andrea Pais
, a University of Florida graduate with a degree in Electrical Engineering, is CEO of Novel Microdevices, Inc., headquartered in Baltimore City, Maryland. She leads the development of groundbreaking, rapid, point-of-care molecular diagnostic solutions. With over 20 years in diagnostics and life sciences, Andrea has secured nearly $11 million in non-dilutive funding, including NIH RADx® Tech support, along with over $11 million in investor funding. Guided by her strategic vision, Novel Microdevices is dedicated to providing clinicians and patients with accessible, lab-quality diagnostic test results in minutes. Andrea is dedicated to transforming healthcare by making high-quality diagnostic testing widely accessible.
Novel Microdevices is in Point-of-Care Diagnostics. Can you introduce the company and its revolutionary technology?
Novel Microdevices, based in Baltimore, MD, at the City Garage Science and Technology Center, is transforming healthcare by making high-quality molecular diagnostics accessible at the point of care. Today’s rapid diagnostic tests often sacrifice accuracy for speed, falling short of lab-based PCR standards. Our platform closes that gap—bringing lab-quality PCR testing directly to clinics, pharmacies, and resource-limited settings, and delivering accurate results in just 15 minutes to support fast, informed treatment decisions.
By eliminating the need to ship samples to centralized labs—a major logistical hurdle in traditional diagnostics—we’re enabling providers to diagnose and treat infections on the spot. We are currently in the late-stage development phase, preparing for regulatory submissions and gearing up for commercialization.
How does it work? What are some of its key features? How quickly does it provide results?
Our platform is a compact, small-footprint molecular diagnostic system that delivers lab-quality PCR results in about 15 minutes, start to finish. It’s fully integrated and automates the entire molecular workflow—including nucleic acid extraction, purification, concentration, amplification, and detection—all within a single-use cartridge. The user simply loads the sample and presses start. The system does the rest.
Key features include:
- Speed – Results in ~15 minutes
- Compact design – Small enough for use in decentralized settings
- Ease of use – No specialized training or lab infrastructure required
- Battery-powered option – Enables flexible deployment, even in low-resource or mobile settings
- Cloud connectivity – Allows secure data transmission and supports remote monitoring or integration with health systems
- Accuracy – Real-time PCR with performance comparable to central labs
- Multiplex capability: 6-channel real-time fluorescence detection enables differentiation of up to six different target pathogens in a single test.
- Affordability – Designed to be cost-effective and scalable for broad adoption
- Flexibility – Adaptable to a wide range of pathogens and sample types, supporting rapid menu expansion
Our system is built for speed and adaptability. New tests require only a change in the primer-specific amplification reagent pellet on the cartridge, allowing us to quickly adapt existing lab PCR assays or respond to emerging threats—a key advantage for pandemic preparedness and public health response.
Our first test is a multiplex respiratory panel for Flu A, Flu B, RSV, and COVID-19 using nasal swab samples. The next test will detect Chlamydia, Gonorrhea, and drug-resistant Gonorrhea, with additional infectious disease panels in development across multiple sample types.
What is the potential impact?
The impact is tremendous—especially when you consider how many people around the world lack timely access to reliable diagnostics. Our platform allows providers to test and treat patients immediately, eliminating the delays of sending samples to centralized labs and waiting days for results. That kind of access is a game changer for both patient care and public health.
For respiratory viruses, it enables quicker decisions around treatment or isolation—and supports antibiotic stewardship by helping avoid unnecessary prescriptions. For STIs, it reduces transmission, accelerates treatment, and detects drug-resistant infections, which is critical for antimicrobial stewardship.
Zooming out, the platform has the potential to expand into over-the-counter (OTC) use—putting actionable health information directly into people’s hands. Its portability, ease of use, and flexibility to rapidly expand the test menu make it ideally suited for broader access in both developed and underserved settings, as well as for a rapid response to emerging infectious threats.
TEDCO recently announced a $500,000 financing for Novel Microdevices. Can you share the impact of this financing and how the funds will be used?
TEDCO has been a strong supporter of Novel over the years, and this $500,000 investment comes at a pivotal time. We’re moving toward GMP manufacturing, preparing for clinical studies, and laying the groundwork for commercialization. These funds will help us accelerate critical activities—finalizing product development, scaling up operations, and building the infrastructure we need to bring our product to market.
Beyond the funding, TEDCO’s support also sends a strong signal to future partners and investors. Having a mission-driven organization like TEDCO behind us reinforces our vision and gives us momentum as we enter this next phase.
In November, Novel Microdevices announced a $2.68 million follow-on funding from the National Institute of Health (NIH) Rapid Acceleration of Diagnostics Tech Program.
The NIH Rapid Acceleration of Diagnostics (RADx®) Tech program has been instrumental in helping us advance our platform. This $2.68 million follow-on funding is supporting our transition into the next critical phase—completing product development, advancing GMP manufacturing, and preparing for clinical studies and regulatory submissions for our respiratory panel.
NIH’s support has gone beyond just funding—they’ve connected us with technical experts, validation partners, and a broader innovation network that’s helped us move faster and smarter. It’s been an incredible partnership that validates both our technology and the need it’s addressing in the healthcare system.
The LaunchPort in Port Covington is a medtech venture that incubates MedTech startups. What role did the LauchPort play in the company’s development?
The LaunchPort played a key role in helping us transition from early-stage development into a more mature, commercial-ready organization. Being part of their ecosystem gave us access to a dedicated space within the accelerator where we could set up our own GMP manufacturing operations, without the burden of a long-term lease or committing to a larger facility before we were ready.
That flexibility—along with the ability to scale our space as the company grows—has been incredibly valuable. It’s more than just a facility—it’s a community of people who understand the unique challenges of bringing a medical device to market. The mentorship and support we received there helped shape how we approached quality systems, regulatory planning, and team development. It’s been a big part of our journey.
Your brother is the co-founder and VP of Engineering. You started the company in your home’s basement in 2015. Please share some of the experiences of starting a company with your brother.
My brother and I are both co-inventors of the technology, and in the early days, we worked side by side—building out the concept, developing the prototypes, and figuring things out from the ground up. We started the company in my basement in 2015, and those first few years were all hands-on: long nights, a lot of trial and error, and a shared determination to bring this idea to life.
As the company grew, I transitioned into a role focused more on strategy, fundraising, and building the business, while he continued leading the engineering and product development. We have very different strengths, but a shared vision and deep trust in each other have been the foundation of this journey. It’s been incredibly rewarding to build something this meaningful together.
What are some of the key milestones over the last decade?
There have been several meaningful milestones along the way. Early on, it was about proving the concept—developing the core microfluidic and PCR technology and demonstrating that it could be miniaturized and automated while still delivering lab-quality results. From there, we built functional prototypes, completed early validation studies, and secured our first SBIR Phase I and Phase II funding.
Since then, we’ve grown the team, established operations at the City Garage Science and Technology Center in Baltimore, and set up our own manufacturing space at The LaunchPort, where we’re now implementing GMP. We’ve also received funding from angel investors, venture capital, TEDCO, and significant non-dilutive support from NIH RADx (Phases I and II) and CARB-X.
Another key milestone has been protecting our innovation—we’ve filed multiple patents covering our core technology, with several already allowed. We’re now advancing our respiratory panel toward clinical studies and preparing for regulatory submissions and commercialization.
Each of these milestones has helped move us closer to our mission of delivering accessible, high-quality diagnostics at the point of care.
What are some of your entrepreneurial journey’s high and low points?
There have definitely been both. The highs are those moments of validation—when we secured key funding, hit major technical milestones, or saw the technology perform exactly as we envisioned. Seeing our first successful test run, growing the team, and getting support from organizations like NIH, CARB-X, and TEDCO—all of that has been incredibly rewarding.
The low points came from the challenge of raising capital—especially in the early days. There were times we couldn’t move as quickly as we wanted to because of funding limitations, and that can be frustrating when you know the urgency of the problem you’re solving. But we stayed focused. We mapped out the most critical milestones, and with every round of funding—whether from grants, angels, or VCs—we used it strategically to hit key value-creating milestones and keep the momentum going.
It’s taken persistence, patience, and a strong belief in the mission. And I’m proud of how far we’ve come, and of the team that’s made it all possible.
How has TEDCO helped you navigate the entrepreneurial and capital journey?
TEDCO has been a consistent and trusted partner throughout our journey. Their support has helped us move forward at key inflection points—from our early days to where we are now, preparing for clinical studies and commercialization.
They’ve provided not just capital, but also access to a broader network, strategic guidance, and visibility within the Maryland innovation ecosystem. As a medtech startup, the path to market is long and complex, and having a mission-aligned organization like TEDCO backing us has made a real difference. Their belief in our vision has helped us build credibility, attract additional investment, and stay focused on creating long-term value.
