Co-Diagnostics, Inc. 8K

Co-Diagnostics, Inc. reported second quarter 2026 results, a narrowed net loss, a $3 million private placement, and major operational and regulatory progress, including FDA 510(k) submission for its Co-Dx PCR Flu A/B/RSV test and global commercialization and manufacturing initiatives.

On August 13, 2026, Co-Diagnostics, Inc. reported its financial results for the quarter ended June 30, 2026, highlighting minimal revenue growth to $0.17 million and a reduced net loss of $6.3 million versus the prior year, while emphasizing operational milestones including advancing its CoMira manufacturing strategy in Saudi Arabia, expanding its Vector Smart customer base in the U.S., progressing tuberculosis and Ebola-related assay development through its CoSara joint venture, and strengthening liquidity through a $3.0 million at-the-market private placement. The company also disclosed completion of clinical and analytical studies and submission of an FDA 510(k) premarket notification with a concurrent CLIA Waiver application for its Co-Dx PCR Flu A/B/RSV test on the Co-Dx PCR Pro instrument, a key regulatory step toward commercialization of its point-of-care molecular diagnostics platform. Additional developments included the appointment of Wes Lindsey, Ph.D., MBA, as Chief Scientific Officer to lead scientific and regulatory strategy, initiation of clinical performance studies in India for the CoSara PCR MTB test, and demonstration of an automated manufacturing line to support scalable production and localization efforts, all framed within continued investment in an integrated PCR platform with cloud and AI-enabled capabilities and acknowledgment of the company’s ongoing liquidity needs and regulatory and market adoption risks.

Filing Facts

CIK

1692415

Ticker

-

Form

8K

Source Type

sec

Accession

0001493152-26-037739

Alert Tier

7