About

What drives us

Mission

ElevenGene Labs exists to solve one specific problem: good diagnostic technologies do not reach the Brazilian market at the speed, or with the solidity, they deserve.

Brazil is the largest in vitro diagnostics market in Latin America — about USD 4.2 billion in 2024, according to Grand View Research, with enormous pent-up demand in molecular biology. And yet manufacturers with technically superior products spend years stuck on incomplete dossiers, ill-suited distributors, data ANVISA questions, and commercial strategies that have nothing to say to the Brazilian buyer.

Our mission is to close that gap.

We accelerate the entry, registration and commercialisation of molecular diagnostic products in Brazil — with scientific rigour, regulatory intelligence and commercial strategy brought together under a single point of accountability.

We are not a consultancy that delivers reports. We are the partner who comes in alongside you, takes on the technical and strategic problems, and considers the work finished only when the product is on the market and selling — through the right channel, with the positioning that protects the margin.

Vision

To be recognised as the technical and strategic reference for companies building a sustainable position in the Brazilian molecular diagnostics market.

We are not trying to be the biggest consultancy — we are trying to be the most precise. The one the best manufacturers choose when entering Brazil cannot go wrong. The one whose name on a dossier, a validation or a commercial strategy means the work was done to the standard the Brazilian market demands.

By 2030 we want to have helped put at least 50 high-quality molecular diagnostic products on the Brazilian market that, without ElevenGene, would not be there — or would have arrived decades late.

Every registration we accelerate is a more accurate diagnosis for a Brazilian patient. Every well-positioned product is a laboratory that can now offer a test its city did not have. That is what drives us beyond the business.

Values

1. Rigour before speed

The diagnostics market does not forgive shortcuts. A sensitivity figure calculated the wrong way, a dossier missing an apostille, a distributor chosen for geographic coverage rather than technical capability — each of those mistakes costs months and hundreds of thousands of reais. At ElevenGene, speed is the consequence of correct method, not a substitute for it. We get it right the first time because doing it again costs far more — for the client, and for the patients waiting on the product.

2. Technical independence as a non-negotiable

When we assess a technology, a dossier or a commercial strategy, the conclusion follows the data — not our interest in closing a contract or pleasing a client. We have told a client their product was not ready for submission. We have advised an investor not to proceed with a technology that would not survive ANVISA’s scrutiny. That independence is not a risk to the business — it is the basis of our credibility. One client who trusts our assessment because they know we will be honest when the answer is unwelcome is worth more than ten who want to hear what they already think.

3. Deep specialisation, not convenient generalism

ElevenGene does not do everything. We do not register medicines, we do not audit ISO management systems, we do not run digital marketing for laboratories. We do molecular diagnostics — regulation, validation, strategy and commercialisation — at a depth that is only possible once you stop trying to be good at everything. That specialisation is not a limitation: it is what lets us deliver a quality no generalist can replicate. The Brazilian IVD market is complex enough to deserve people who devote themselves entirely to it.

4. Brazil as the context, not as a variable

Most market-entry mistakes in Brazil begin with the assumption that the European or North American market is the standard and Brazil is an adaptation of it. Brazilian epidemiology is different. The circulating subtypes are different. The Brazilian buyer values different attributes. The regulatory process has a logic of its own. ElevenGene was born in Brazil, operates in Brazil, and thinks about molecular diagnostics from Brazilian reality outward — not as a translation of someone else’s reality, but as the starting point for everything we do.

5. Partnership with skin in the game

Some of our services are paid on commission over the sales they generate. That is not merely a commercial model — it is a statement of values. When ElevenGene only earns once the client earns, the alignment of incentives is real. There is no report delivered and project closed while the product is not performing. That willingness to put skin in the game — to carry the risk alongside the client — is what separates a consultancy selling services from a partner sharing the outcome.

6. Radical transparency about our limits

We know what we do well. We also know what we do not do, what we are not, and where we will tell a client to find another specialist. When a project calls for IP legal expertise, we point to partner firms. When the problem is the product — not the channel or the regulation — we say so before proposing any solution. Being transparent about the limits of our mandate does not make us smaller: it makes us trustworthy. And in molecular diagnostics, trust is the most valuable asset there is.

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Why ElevenGene Labs

The Brazilian in vitro diagnostics market keeps expanding — Grand View Research projects USD 5.6 billion by 2030. There is a real window — but a narrow one — for companies that arrive with the right product, in the right segment, with the right validation and the right channel.

That window does not wait.

ElevenGene Labs exists to make sure the best molecular diagnostic technologies do not miss that window for want of a strategy, because of a badly structured dossier, or because of a distributor who cannot explain the product to a specialist biomedical scientist.

We are the difference between reaching Brazil and reaching Brazil the right way.