Why OraSure Built a Collection Kit, Not a Better STI Test

A diagnostics company can spend years chasing a more sensitive assay and still watch the test go unused, because the chemistry in the lab was never the part that decided whether anyone benefited. The part that decides is whether a person ever produces a sample to run. OraSure took that seriously. Last week it cleared a product most people will skim right past, a urine collection kit, and I think that was a sharper product call than another assay would have been.

What OraSure actually cleared

On June 11 the FDA cleared OraSure’s Colli-Pee Dx kit, developed through its DNA Genotek unit, for at-home collection of a first-void urine sample that screens for four sexually transmitted infections: chlamydia, gonorrhea, trichomonas, and Mycoplasma genitalium. A person collects at home, drops the kit in the mail, and the sample runs on Roche’s cobas 5800, 6800, and 8800 systems, the molecular analyzers many high-volume labs already own. OraSure did not build a new assay or a new analyzer. It built the step in front of both, with a stabilization chemistry it calls NucleoPrecision that holds the DNA and RNA at room temperature so a mailed sample is still good when it arrives. Chief executive Carrie Eglinton Manner framed the clearance as connecting people to care that is more accessible and private. That is marketing language, but it names the actual constraint.

The bottleneck was never the test

Screening assays for these infections are not the weak link. Labs have run accurate molecular STI panels for years. The weak link is human. A clinic visit, a clinician-collected swab, the time off work, the discomfort, the loss of privacy, all of it sits between a person and a result, and a lot of people who should be tested simply are not. A urine sample you collect at home and drop in the mail removes most of that. The win is not a better number on a sensitivity chart. The win is more people getting tested at all.

I make a version of this argument constantly about surgical robots. The debate people want to have is whether a robot-assisted surgeon gets better outcomes than the small group who can do the procedure by hand. My answer is that it does not matter, because it is the wrong question. The point of the robot is to grow the population of surgeons who can do the procedure by orders of magnitude, which grows the population of patients who get a minimally invasive option. More surgeons, more patients. The same shape holds here. Is the assay better? Does not matter. More people will actually get tested, and that is where the value is.

Where founders point the effort

For a diagnostics or hard-tech founder, the lesson is about where you spend scarce product and regulatory effort. The impressive work, the novel assay, the cleaner algorithm, the more dexterous machine, is usually not the step that gates real adoption. The dull human step in front of it usually is, and it is the one founders skip because it does not demo well. OraSure pointed its clearance at the collection step and let Roche’s installed analyzers do the rest, which is a faster road than convincing labs to swap hardware. If you are building a diagnostic, ask which step actually loses patients between intent and result, and put the regulatory dollars there. If you are selling into hospitals, ask the same question about the workflow gap that keeps a clinically sound product sitting on the shelf. The accuracy you are proud of is table stakes once someone is in the room. Getting them in the room is the harder product, and the less glamorous one.

Dave Saunders is the founder of Base Reality Group and a Fractional CPO for hard-tech founders. He was a founder and operator at Galen Robotics, where the surgical-robotics platform earned FDA De Novo authorization in 2023, and he managed a 35-patent portfolio licensed from Johns Hopkins. He wrote Founders Who Finish and publishes The Build. More about Dave →