Innovexis Inc. emblem Innovexis Inc.
Based in Southern Maine

Rapid tests that survive contact with the real world.

Andrew Wheeler — twenty-five years developing lateral flow and point-of-need diagnostics, from food safety to FDA EUA-authorized home tests. I work with teams that just have an idea, teams whose chemistry already works on the bench, and teams that need help finalizing development and getting a product shipped.

Start a conversation See the track record
sample port result window plastic housing test control sample pad conjugate pad nitrocellulose membrane absorbent pad Matrix release · viscosity · pH Conjugate stability · gold size · non-specific binding Flow rate · lot variation
Five layers, one capillary path contained within a plastic housing. Almost every failure I get called in for lives at one of these seams.

“A lateral flow immunoassay only works when material science, fluidics and immunology agree with each other. Getting them to agree is the entire job.”

Verifiable record
FDA Emergency Use Authorization
Led development and authorization of COVI-Go, a home-use SARS-CoV-2 self-test cleared for over-the-counter use in February 2023.
$525,000 NIH grand prize
Grand Prize winner, NIH RADx Tech for Maternal Health Challenge, October 2024 — a home UTI test for postpartum women.
Peer-reviewed publication
Co-author, “The development of lateral flow devices for urinary biomarkers to assess kidney health” — Scientific Reports, 2024, with a university nephrology group.
Eight issued patents
Plus a long tail of applications, all in diagnostic science — including the architecture behind an integrated multiplex analysis platform still sold into food safety testing.

Where I come in

Usually a few months after the money lands.

You have a binding pair that performs beautifully in buffer, a grant with a clock on it, and no one on the team who has taken a strip from a working protocol to something a manufacturer can build ten thousand of. That gap is where programs quietly lose a year.

The chemistry is rarely the thing that costs the schedule. It is sample preparation from a difficult matrix, reagent stability without a cold chain, lot-to-lot reproducibility, a housing that a nurse or a parent can actually operate, and a regulatory path chosen early enough to still be cheap. I have hit every one of those walls, in food safety, veterinary, environmental and human health, and I know roughly what they cost.

What Innovexis does

Engaged by the week, the project, or as named personnel on your grant.

Assay development

Immunoassay and non-amplified nucleic acid detection

Antibody pair selection and conjugate chemistry through to a strip that reads correctly in the matrix you actually have. Sample types across my career have run from raw shrimp to human saliva.

Non-amplified nucleic acid detection as well — identifying nucleic acid targets without PCR, a thermal cycler or a cold chain, in a format an untrained operator can run outside a laboratory. I have built detection schemes to specifications calling for up to ten pathogens and host biomarkers on one disposable device, alongside a massively multiplexed format addressing a thousand or more targets for biosurveillance.

Platform design

Cassettes, cartridges and readers — light engineering

Most assay consultants stop at the nitrocellulose. I design the object around it. I conceived and led an integrated multiplex analysis platform for food safety testing that is still on the market, and hold utility and design patents covering assay cartridges, fluid retainer assemblies and readers.

Diagnosis and rescue

Why it works in the lab and fails in the field

Independent technical due diligence on a platform you are about to fund, or a structured teardown of one that is misbehaving: matrix effects, non-specific binding, hook effect, sampling error, dynamic range. I hold a patent on immunochromatographic assay desensitization, which is a formal way of saying I have spent a long time on this particular problem.

Transfer and quality

From bench protocol to something a plant can build

Design transfer, process definition, supplier and material qualification, and quality systems under 21 CFR 820 and ISO 13485. I have moved multiple products from research into manufacturing and lived with the consequences on the other side.

Strategy and funding

Regulatory path, go-to-market, and grant support

Which pathway, which claim, which market first — and the proposal work to fund it. I have run federally funded diagnostic programs across civilian and defense agencies, taken a product through FDA authorization, and grown a US subsidiary from seed funding to more than $20M in revenue. I am available as named assay personnel on SBIR, STTR and foundation applications.

Twenty-five years, five industries

The same physics, very different customers.

Patents

Issued

Assay detection systems, quantitative testing platforms, cartridge and reader design.

Alongside published applications covering saliva testing, assay desensitization, reduction of biological sampling error by image processing, and universal quantitative testing platforms. Full list available on request.

Get in touch
Andrew Wheeler, founder of Innovexis Inc.

Tell me what isn’t working.

A first conversation costs nothing and usually takes half an hour. If it turns out I am not the right person, I will generally know someone who is.

andrew.wheeler@innovexis.bio Southern Maine, USA

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