A Blood Test That Knows If It's Schizophrenia or Bipolar Disorder

The Numbers Are Hard to Ignore

As part of the FDA's review process, Laguna reanalyzed its pivotal study data using a locked algorithm (meaning no tweaking after the fact to make results look better). The results from that reanalysis:

96.7% sensitivity for schizophrenia. That means the test correctly identified almost every schizophrenia patient in the study.

On the bipolar I side, it posted 100% specificity, meaning no bipolar patients were incorrectly labeled as having schizophrenia. Overall accuracy clocked in at 98.3%.

Now, caveats matter here. These numbers come from a controlled study population of about 90 subjects. Real-world performance across larger, more diverse groups could look different. The test still needs broader clinical validation before anyone can order it. But as early data goes, this is eye-catching.

What "Breakthrough" Actually Means (and Doesn't)

The FDA granted Laguna its Breakthrough Device Designation in late April 2026. That sounds dramatic, and it is meaningful, but it's worth understanding what it actually does.

Breakthrough status doesn't lower the bar for approval. It doesn't mean the test is cleared for use. What it does is move Laguna to the front of the line for FDA interactions, give the company more frequent feedback from regulators, and prioritize the eventual review of its marketing application. Think of it as a VIP pass at the airport: you still go through security, but you skip the two-hour line.

To qualify, a device must address a life-threatening or irreversibly debilitating condition and offer a significant advantage over existing options. In this case, there are essentially no existing objective diagnostic tools for this specific differential diagnosis, so the bar for "significant advantage" isn't hard to clear.

The Bigger Picture for Drug Development

Beyond the clinic, this kind of test could ripple through CNS drug development in a big way.

Psychiatric clinical trials have a notorious failure rate, and one of the biggest reasons is patient heterogeneity. When you run a schizophrenia trial but 15% of your enrolled patients actually have bipolar I (because the clinical diagnosis was wrong), you're diluting your signal. It's like testing a new recipe but accidentally mixing in the wrong ingredients; of course the results will be inconsistent.

An objective blood-based test that can stratify patients more accurately at enrollment could make trials smaller, faster, and more likely to succeed. For pharma companies that have spent billions watching CNS trials fail, that's not a minor convenience. It's a potential game-changer for how precision psychiatry studies get designed.

A Crowded Starting Line, but an Empty Track

Laguna isn't the only company chasing biological diagnostics in mental health. The broader landscape includes proteomic panels, metabolomic signatures, pharmacogenomic tests (which help choose medications, not diagnose conditions), and even AI-driven platforms that combine blood markers with digital phenotyping data from smartphones and wearables.

But here's the thing: none of them are FDA-cleared for psychiatric diagnosis yet. The entire field is pre-commercial. Laguna's Breakthrough designation puts it among the most advanced in a race where nobody has crossed the finish line.

The company is currently raising about $5 million in seed funding to complete lab validation, hire key staff, and launch an FDA-supported clinical validation trial. It's small; co-founded by CEO Terry W. Osborn (a molecular diagnostics veteran) and M. Marquis P. Vawter, a research professor of psychiatry at UC Irvine whose functional genomics work underpins the patent.

What Comes Next

Laguna's near-term plan is to offer the test as a laboratory-developed test (LDT) through a certified lab partner while it works toward full FDA marketing authorization. That could put it in clinicians' hands sooner, even before the formal approval process wraps up.

But the road ahead has real hurdles. The company needs to validate performance in larger, more diverse populations. It needs to prove the test holds up outside controlled study settings. And it needs to convince payers that a blood-based psychiatric diagnostic is worth covering.

Still, the core idea is powerful. Psychiatry is one of the last major branches of medicine where diagnosis depends almost entirely on conversation rather than biology. If a $50 blood draw could shave years off the diagnostic journey for millions of patients, the implications go far beyond one small company in Irvine.

The test hasn't been approved. It hasn't been validated at scale. But for a field that has waited decades for something objective to hold onto, even a strong signal from 90 patients and a Breakthrough designation feels like the ground is finally shifting.