Diagnostics as a Service for wellness startups launching their first blood test

Wellness brands planning a first blood testing launch should start with one number. A meta-analysis of 26 studies covering more than 16 million blood sample requests found that around two in every hundred samples are rejected before anyone analyses them. Almost every cause is a handling problem rather than a laboratory problem, because the sample clotted on the way, it broke down, there was not enough of it or the label was wrong.¹

A separate study of roughly 11 million specimens reached the same conclusion more plainly, because of all the errors it recorded, 98.4 percent happened before the sample ever reached an analyser.²

So the part of blood testing most likely to fail your customer is the part before the laboratory, which means how a sample is collected matters more than which markers you choose to measure. That is an awkward fact for a first launch, because collection is also the decision you have to make earliest and with the least information, and it is the hardest one of all to reverse.

You do not yet know the four things that matter

Before your first launch there are four questions that are genuinely open, and no amount of planning will close any of them.

• Which panel people choose when they have to pay for it themselves.
• What price those people are actually willing to accept.
• How many buyers complete a test after they have paid for one.
• How much work a single out-of-range result creates for your support desk.

Fifty paying customers will answer all four of those questions inside a month, which means every preparation you make before those fifty customers is a guess. Guesses are unavoidable at this stage and there is nothing wrong with making them, but some of those guesses are cheap to correct and one of them is not.

Kit inventory is the guess you cannot correct

Most early decisions are cheap to change, because a landing page takes an afternoon and swapping a marker in a panel takes an email.

Boxes are different, because paying for kits fixes your panel, your collection method and your packaging in a single transaction, and none of that changes until the stock is gone. If your customers turn out to want hormone markers and you have bought a metabolic panel, you cannot return the boxes.

Mailed kits carry a second problem that has nothing to do with your choices, which is that a good number of people never send them back. A customer buys the kit with real enthusiasm, then it stays on a shelf for a while, and three months later somebody finds it in a drawer with the expiry date passed.

When that happens you have paid for the kit, the postage and the customer without having a single result to show them. A test that is never taken is worse for you than one that fails, because a failure at least tells you something about your process.

A fingertip will not fill a broad panel

There is also a physical limit on what a kit can do, and no supplier is able to change it.

A capillary sample from a finger produces about 600 microlitres of serum, every marker consumes part of that volume, and a panel of forty markers needs considerably more than a fingertip can give you.

The rejection data shows the same problem from the other direction, because in that meta-analysis insufficient sample volume caused roughly a fifth of all rejections, alongside clotting and breakdown of the sample.¹ A collection method that only just produces enough on a good day will not produce enough on an average one.

So you are really choosing between two products here rather than between two logistics options.

• A short and focused panel suits capillary collection, and for the customer that is by far the easier experience of the two.
• A broad panel needs a blood draw taken by a trained person, because no amount of packaging design will make a finger-prick deliver the volume.

Settle that choice first, because it determines almost everything that follows from it.

Your investors will ask about accuracy, and the answer follows that choice

Your investors will ask and so will your customers, because home testing has a reputation for being less reliable than a proper draw, and the rejection figures above show that the reputation is not baseless.

You have two ways of answering that question.

The first is to explain at length why your particular kit is better than its reputation suggests. That argument can be won, but you will be having it repeatedly, with every investor and every sceptical customer.

The second is to use a blood draw taken by a trained person and analysed by an accredited laboratory, which is the same sample a doctor would take, and then say exactly that in a single sentence. The second answer is shorter and it does not need defending.

Selling your own kit changes what your company is

The kit decision has one more consequence, and it is the one that stays with you longest.

If you place your own self-test kit on the European market then you are a device manufacturer. Under the in vitro diagnostics regulation a self-test is class C by default.³ That classification brings a notified body assessment, a study showing that untrained people can use your kit correctly, and a requirement that the kit warns a user when a result is not valid.⁴

Sending a sample from a professional draw to an accredited laboratory does not put you in that position, because you are buying a service instead of manufacturing a product.

Read the rule itself before you commit either way, since it is two sentences long and it changes your first year more than any other decision on this list. What the full build involves is set out in our article on running blood testing yourself.

Which parts of Diagnostics as a Service can wait

With the collection decision made, everything else can be sorted into two piles, and most launch delays happen because something from the first pile was treated as though it belonged in the second.

These can wait until you have paying customers:

• The final panel, because you can add and remove markers once you see what people buy.
• Kit packaging and unboxing, because you do not need kits at all in month one.
• At-home collection, which is an expansion of the product rather than a starting point.
• A custom panel, because your first customers will buy a standard one quite happily.
• Your own results dashboard, since a branded one will do until the volume pays for building.
• Additional countries, because one market that works beats three that half-work, and each border changes the rules anyway.

These have to be settled before you launch:

• Your collection method, because a draw and a finger-prick are two different products with two different regulatory positions.
• Whether you sell your own kit, which is hard to reverse for the reasons set out above.
• Who holds the laboratory accreditation, because if it is not clearly your supplier's laboratory then it is you.
• Your data agreement and where customer data is held, since fixing that after you hold real health records is far worse than doing it once at the start.
• What happens when a result is worrying, because the first time it happens you do not want to be inventing the process with a frightened person waiting.

Run fifty paying customers and count four things

Once those five questions are settled, the launch itself should be deliberately small.

1. Pick one panel and one collection method, and do not offer alternatives yet.
2. Open it to roughly fifty to a hundred people in a single country.
3. Charge those people properly, because a free pilot tells you nothing about what somebody will pay.
4. Count four numbers over the month that follows.

The four numbers are how many buyers complete a test, how many results come back usable, how many people contact support afterwards, and how many of them buy something else from you.

Those are the same four questions you could not answer before launching, which is the whole point of the exercise. They are also what any serious supplier needs before quoting you properly, so a single cohort answers your questions and theirs at the same time.

Keep the first commitment small enough to be wrong

There is one more reason to start small, and it is the reason nobody in this category says out loud.

Nobody has published independent evidence that adding blood testing improves retention for a consumer health product. Several large brands have added a testing layer since 2024, but none of them has published the effect on repeat purchase, on customer lifetime value or on payback, so what circulates instead is marketing.

That is not a reason to avoid this, but it is a reason to make your first commitment small enough that being wrong costs you a quarter rather than a year. Get your four numbers first and then spend properly, and our article for larger brands explains why the measurement is worth having even without the retention argument.

How Aniva delivers Diagnostics as a Service for a first launch

Aniva owns its blood draw network across Germany instead of subcontracting it, which is why a first launch here needs no kit inventory at all.

• Your customer books a blood draw at one of our partner locations.
• A trained person takes the sample and an accredited laboratory analyses it.
• The result comes back under your brand, on your dashboard and your report.
• When your volume justifies kits, capillary collection, at-home kits, saliva, urine and stool all run through the same ordering flow and return the same result format, so adding one later is a configuration rather than a second integration.

Diagnostics as a Service, or DaaS, is available to partners across Europe, and the same starting pattern applies in each market. Volume and term are agreed per contract, because they depend on the panel you want to sell, so bring the size of your first cohort to a call and you will get a real answer.

Book a 30-minute demo whenever it suits you. If your engineers are the ones asking the questions, send them to Aniva for Developers and let them order a test panel in the sandbox first.

A summary of the main points

• Around two in a hundred samples are rejected before analysis and collection is the reason, so collection is your most important early decision.
• Everything else worth knowing comes from paying customers rather than from more planning.
• Kits are the one early decision that cannot be corrected, so leave them until last.
• A fingertip cannot fill a broad panel, and insufficient volume is already a leading cause of rejection.
• Settle the kit question, the accreditation question, the data agreement and the abnormal result process before you launch.
• Run fifty paying customers through one panel in one country, count four things, and let those numbers decide how big this becomes.

Questions we are asked most often

Can I launch blood testing without buying kits?

Yes, provided your supplier owns or contracts physical collection sites, because then your customer books a draw, a trained person takes the sample and an accredited laboratory analyses it. Nothing is stored in your warehouse at any point. Kits become worth buying once you know which panel sells and how many customers complete a test.

How many markers can a finger-prick test measure?

A capillary sample gives about 600 microlitres of serum and every marker consumes part of it, so a panel of forty markers or more needs a venous draw. Insufficient sample volume already causes roughly a fifth of all specimen rejections.¹ Capillary collection works well for a short and focused panel.

How often do blood samples get rejected?

A meta-analysis of 26 studies covering more than 16 million requests found a pooled rate of about two in a hundred, with regional subgroups ranging from 0.55 percent to 2.82 percent.¹ Clotting, breakdown of the sample, insufficient volume and labelling errors account for most of that. Your own rate depends on the collection method you choose.

Do I need my own laboratory accreditation?

You do not need it yourself, as long as the laboratory analysing the sample holds it, because accreditation belongs to the laboratory doing the work rather than to the brand selling the test. Ask any supplier which laboratories run your panels, and get that answer in writing before you sign anything.

Does selling a home test kit make me a medical device manufacturer?

Placing your own self-test kit on the European market brings you under the in vitro diagnostics regulation, where a self-test is class C by default.³ That means a notified body, a study showing that untrained users can operate the kit, and a warning to the user when a result is not valid.⁴ Sending a professional draw to an accredited laboratory avoids that route, though you should confirm your own position with a regulatory advisor.

What should I decide before launch and what can wait?

Settle your collection method, whether you will sell your own kit, who holds the laboratory accreditation, where customer data is held, and what happens when a result is worrying. The panel composition, the packaging, at-home collection, custom panels, your own dashboard and additional countries can all wait until you have customers.

Notes and sources

1. Getawa S, Aynalem M, Melku M, Adane T. Blood specimen rejection rate in clinical laboratory: a systematic review and meta-analysis. Practical Laboratory Medicine 2022;33:e00303. Pooled rejection rate 1.99 percent across 26 studies and 16,118,499 requests. Leading causes: clotted specimen 32.2 percent, haemolysis 22.9 percent, insufficient volume 22.8 percent, labelling errors 7.3 percent. Regional subgroups range from 0.55 percent in the Americas to 2.82 percent in Asia, so the pooled figure is not a European rate. doi:10.1016/j.plabm.2022.e00303
2. Lin Y, Spies NC, Zohner K, McCoy D, Zaydman MA, Farnsworth CW. Pre-analytical phase errors constitute the vast majority of errors in clinical laboratory testing. Clinical Chemistry and Laboratory Medicine 2025;63(9):1709 to 1715. Of 87,317 recorded errors across roughly 11 million specimens, 98.4 percent were pre-analytical. Single institution, and the figure is dominated by haemolysis. doi:10.1515/cclm-2025-0190
3. Regulation (EU) 2017/746 on in vitro diagnostic medical devices, Annex VIII, Rule 4(a). legislation.gov.uk
4. Regulation (EU) 2017/746, Annex I, point 19, on devices intended for self-testing, including point 19.3 on invalid result warnings. legislation.gov.uk

This article is general information for companies planning a first blood testing launch. It is not legal, regulatory or financial advice. Laboratory accreditation and reference intervals belong to the analysing laboratory, and interpretation of any individual result remains with a treating clinician.