Co-Diagnostics (Co-Diagnostics (CODX)) just crossed a big regulatory finish line — or at least, the last checkpoint before the finish line. On Wednesday, the molecular diagnostics company said it wrapped up the clinical and analytical performance studies for its Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test, which runs on the Co-Dx PCR Pro instrument.

These studies are the backbone of the submission package the company plans to send to the FDA. And the target is ambitious: a Dual 510(k) and CLIA Waiver by Application submission, currently slated for the third quarter of 2026.

“Completing both the analytical and clinical performance studies for the upper respiratory test is a significant execution milestone for Co-Diagnostics,” said Dwight Egan, CEO of Co-Diagnostics.

The FDA doesn't let medical device makers just waltz in with a test and ask for clearance. Before you can submit an in vitro diagnostic (IVD) test for review, you need to show it works reliably in both controlled lab conditions and in the messy real world. That means extensive analytical and clinical validation studies.

Co-Diagnostics took that seriously. The analytical validation alone involved over 10,000 PCR test cup runs across 27 individual studies. Some of those studies were specifically designed to support the CLIA Waiver by Application, which would allow the test to be used in point-of-care settings — think doctor's offices and clinics — without a full lab setup. The company also ran a rigorous external multicenter reproducibility study, which showed consistent performance even when untrained operators handled the test across different sites and instruments.

“The FDA 510(k) and CLIA Waiver by Application processes require substantial analytical and clinical evidence, and the depth of the work our team has completed, including 27 individual analytical studies, over 10,000 PCR test cup runs, and a clinical study enrolling more than 1,400 symptomatic patients… We are targeting submission in Q3 2026 and remain confident in our path to clearance,” Egan added.

This isn't the only thing Co-Diagnostics has been up to. In March, the company signed an agreement with CoSara Diagnostics Pvt. Ltd to expand its commercial and distribution territory across South Asia, adding Bangladesh, Pakistan, Nepal, and Sri Lanka to its reach. That move significantly increased CoSara's addressable market, bringing the total regional opportunity to an estimated $13 billion, based on internal analyses and third-party data.

And in May, Co-Diagnostics completed the assay development strategy for the Bundibugyo virus (BDBV), which has been causing an Ebola outbreak in the Democratic Republic of the Congo and Uganda.

As for the stock, CODX shares were down 0.65% in premarket trading Wednesday, sitting at $3.08. That's not far from the 52-week low of $1.26, according to market data. But with a potential FDA submission on the horizon, the company is hoping its respiratory test can help change that trajectory.