Andrew Dahl, founder and chairman of BioMEMS Diagnostics, shared how his business seeks to transform the diagnostics sector, in response to emailed questions.

Why did you start this company? 

Throughout my years consulting or managing various biotech and medtech projects, the idea of measuring improvements in overall health and not the specific diagnosis or monitoring of disease, injury or impairment was a challenge I kept coming back to. After all, medicine has for centuries focused on what was wrong and how to fix it. So, if an annual physical reveals no deterioration in your health and test results are “negative”, most people assume they’re healthy. Not necessarily. They’re just not sick at that moment. The same applies to healthy aging. Negative test results using traditional diagnostics and regular checkups don’t provide much insight into the aging process. 

There are aging biomarkers to be measured, but no credible, validated test panels and certainly nothing in clinical practice at point of care. I was looking to discover or develop a means to detect and quantify metabolic and nutritional endpoints that have been largely ignored by diagnostics developers because there are more pressing or high-profile biomarkers in traditional medical diagnostics, such as neurological disease or cancer. I collaborated with extraordinary individuals to develop a platform that is just as extraordinary when applied to medical diagnostics, as well as metabolic or nutritional applications. 

Our CSO, Michael Pugia, a pioneer in lab-on-a-chip (LOC) and medical diagnostics process technologies, along with CEO Casey Fowler, lead engineer Mike Edmonds, lab director Zane Baird and a dedicated group of collaborators have developed an end-to-end platform technology. It has the potential to outperform the “big iron” diagnostic analyzers that fill central labs today and outdistance most every point-of-care device on the market. 

Andrew Dahl

That’s a big claim. It impacts the way diagnostics are developed, deployed and administered, which, in turn, changes the downstream protocols and practices. Most importantly, when one is now able to quickly develop ultrahigh-performance test panels to detect and measure just about anything at POC, what opportunities to markedly change healthcare delivery become possible? Imagine a saliva-based TB/HIV/HEP test panel with results in minutes on the spot, anywhere in the world, administered by an unskilled aid worker and where the results can be acted upon immediately. Or the caregiver of a homebound senior using a simple oral swab to monitor a dozen or more life-threatening metrics, the results ported in minutes to the caregivers’ smartphone and transmitted to the accountable care organization.

It’s a worthwhile endeavor. It’s what I’m dedicating the rest of my life toward.

What need are you seeking to address in healthcare? 

The BioMEMS test platform can vastly broaden the options and opportunities for testing what was previously inaccessible, unaffordable or impractical to do, whether at home, a clinical site, a doctor’s office or a tent hospital in South Sudan. As a trend, the entire diagnostics industry is moving ever closer to the patient to enhance response time, treatment options, monitoring, etc. We’ve made that possible with a novel testing platform equally competent for precision medicine, clinical monitoring or large-scale public health screening events. The platform encompasses raw bio-sample collection, processing, analysis, reporting, uploading and archiving of results at POC in minutes. Further, we can bring to market high-need, high-complexity, esoteric POC test panels in months, not years. Again, this is no small claim or incremental improvement. 

When the impediments and limitations to deploying rapid, accurate and affordable diagnostics are removed, the entire practice and protocol of diagnostics and how they’re applied can be dramatically transformed, made more responsive, far-reaching and effective. We advise our prospective corporate partners to let their imaginations guide the test development process, not self-imposed technical, operational or economic parameters.

What does your product do? How does it work? 

The BioMEMS diagnostics platform, consisting of a single-use test cartridge, handheld analyzer and mobile app, can detect and quantify any target biomarker in any target biofluid with picomolar sensitivity and specificity. Rapid, high-performance, non-invasive diagnostics for most any infectious or systemic disease, metabolic disorder or nutritional deficiency at point of care or at home are now possible.

Our name defines the underlying technology – Biomedical MicroElectroMechanical Systems –applied to medical diagnostics and subclinical metabolic/nutritional endpoints.

If an antibody or affinity agent exists, we can develop an assay for that particular biomarker and multiplex it with up to 10 other biomarker assays within an individual cartridge. Our novel biomedical microelectromechanical sensors housed within that single-use test cartridge can be configured to detect and measure most anything from a single pathogen to a small molecular entity in biofluids such as saliva, urine, whole blood, mucus, sputum, etc. at picomolar levels, usually in less than 5 minutes. Previously undetectable or unquantifiable biomarkers present at extremely low concentrations in any biofluid can now be measured quickly and reliably at point of care, at home or point of need. We’ve tested applications in fertility, autoimmune and infectious disease studies, among others.

BioMEMS is initially focusing on high-need, high-complexity diagnostics panels as defined by our prospective partners. For example, we’re currently in discussions with a multinational based in Geneva to develop a saliva-based test panel for Vit B1, B6 and B12 deficiency, to be marketed outside the U.S. and EU. Vitamin B deficiencies in many parts of the world are routinely misdiagnosed as neurological disorders, Parkinson’s, Alzheimer’s and mental health problems because B vitamins are critical to the production of neurotransmitters. The stated intent is to have the tests and analyzers sold and distributed to medical practices, NGOs and governments worldwide by the global brand partner. BioMEMS would focus on product development, compliance and manufacturing.

In another instance, BioMEMS is proposing to its prospective corporate customer a healthy aging urine test panel for at-home monitoring of key aging factors, among them low-level, chronic inflammation pathways, cell/organ senescence and metabolic energy levels, aimed at affluent seniors in developed countries. The test kit and mobile app allow the user to monitor key biomarkers and chart improvement or deterioration due to changes in diet, activity, sleep, hydration and other user-managed parameters.

Is this your first healthcare startup? 

As CEO, I initiated and led the IPO of a biotech company to the Nasdaq exchange in June 2021 and set that company on a stable glidepath toward licensing its discovery-stage candidates to Big Pharma. It was a multiyear effort that also included building an organization from the ground up. I also drafted a product development and intellectual property strategy to safeguard the patented and patent-pending technology forming the core assets of the business.

Simultaneously, I worked for several years to develop a wellness assessment product in the form of a urine-based test panel of wellness biomarkers and a companion colorimetric urine test. I am the first-named inventor on the issued patent. It was this effort that propelled my interest in discovering or developing a new and novel testing technology with the flexibility to address any medical, metabolic and nutritional biomarkers or endpoints. I’m also keen to develop tests that no diagnostic developer was considering, despite demonstrated demand for esoteric tests or better-performing high-complexity tests, especially infectious disease and immune disorders.

What’s your background in healthcare? 

I came to the life sciences industry almost 20 years ago as a consultant with a background in tech-based Fortune 500 business strategy and marketing planning. Eventually, I took on executive management and product development roles in biotech and medtech companies (named inventor in 20+ patents or patents pending), developed market and business strategies, R&D process optimization and organizational structuring.

What is your company’s business model?

As private label manufacturers or joint venture partners, we develop esoteric and high complexity multianalyte diagnostic panels specified by our corporate customers or strategic partners. Each test panel represents a discrete, free-standing revenue opportunity with its own development, compliance and manufacturing track.

The physical characteristics and protocols of each test panel are unchanged. Only the chemistry changes inside the test cartridge. BioMEMS is in a position to not only displace the complex PCR, flow cytometry, cell-culturing and immunochromatography tests performed in centralized labs, but also largely eliminate the dozen or more POC analyzers.  

We are working toward the vision of a POC environment where an unskilled aid worker or clinic employee can administer and process high-complexity test panels. They can do this by selecting one from a rack of lipstick tube-sized test cartridges, collecting a sample and inserting the test cartridge into a single, multi-panel analyzer and ports the results to any paired smart device. The test results rival any lab-based analyzer or process in use today relative to repeatable accuracy, sensitivity and specificity, much less the cost avoidance of capital equipment and other components.  

The test cartridges are conceptually similar to an empty flash drive. They can be manufactured in the millions as “blanks” and then configured for a particular diagnostics panel by adding the appropriate chemistry in a secondary, automated process. This enables massive scaling in manufacturing and helps drive down the cost of the test cartridges.

The test panels mentioned previously, such as the healthy aging panel or the vitamin B panel, represent free-standing revenue opportunities. BioMEMS will continue to develop test panels in collaboration with its corporate partners, with dozens of such panels eventually in market. If for some reason one of these test kits fails to gain market traction, there are a dozen more in the pipeline to moderate that possibility. The company doesn’t stand or fall on the fate of a single test panel. 

When our latest round of financing is closed, we will be in a position to manufacture 5,000 to 10,000 “blank” test cartridges and then configure lots of 500 to 1,000 test cartridges for a prospective corporate partner to demonstrate accuracy, stability, manufacturability and ease of configuration for that particular test panel. This forms the basis of our go-to-market strategy and protects our intellectual property, as well.

Who is your customer? 

Global brands that make, market or offer diagnostics as a service. We have no desire to develop and market tests independently. We can mitigate market entry risk and rely on steady, dependable cash flow, predictable order sequencing and avoid the headaches of global distribution by partnering with a well-established life sciences, pharma, diagnostics or healthy living multinational.

How do you generate revenue?  

Each custom test panel developed for a private label contract or joint venture is its own revenue stream. For example, global revenues for a saliva-based iron deficiency/thalassemia/sickle cell test panel can range into the multiple millions annually – governments and NGOs are typical buyers. Revenues from sales of the test cartridges and analyzers are collected by our corporate partner and distributed according to the provisions of the private label contract or the joint venture revenue sharing provisions. It’s important to note that we enter into either the private label or joint venture arrangements with volume minimums and pricing floors. We also charge a one-time licensing fee to guarantee market exclusivity for that particular test panel. We have no issue with marking our test cartridges and analyzers with a partner’s brand for a specific test panel or making external cosmetic changes to the cartridges, analyzers or mobile app graphics.

Do you have clinical validation for your product?

We have conducted limited clinical testing for inflammation, fertility, autoimmune and anti-aging biomarkers, typically using known molarities of target biomarkers in spiked urine, blood or saliva samples. 

In order to develop clinical validation, we are offering our R&D-only Gen 1.0 desktop analyzers and test cartridges to academic researchers engaged in clinical trials. By doing so, we obtain independent validation of our system’s repeatable accuracy, sensitivity and specificity, and gather clinical data for analysis and process refinement. Clinical validation is set to begin in late summer/early fall 2022.

For life science companies: At what stage of development is your lead product?

Gen 1.0 benchtop analyzers – first CE-marked, limited production release slated for September 2022

Gen 2.0 POC test cartridges/handheld analyzers – production intent samples scheduled for late Q4 2022

For more information, contact Andrew Dahl: adahl@biomemsdiagnostics.com

Photo: Natali_Mis, Getty Images