Co-Diagnostics submits dual FDA application as cash falls to $3.6M

RegulationEarnings
โดย Seeking Alpha·US·Read original
Summary · why it matters

Co-Diagnostics has officially submitted a dual 510(k) and CLIA waiver application to the FDA for its flu A, B and RSV assay on the Co-Dx PCR platform. The company reported second quarter 2026 revenue of $166,000 and a net loss of $6.3 million, or $1.46 per share, while cash and cash equivalents fell to $3.6 million. Management also announced the hiring of Dr. Wes Lindsey as Chief Scientific Officer and said it is targeting additional regulatory milestones later this year, including planned submissions to India's CDSCO and the World Health Organization's Expert Review Panel for Diagnostics for its tuberculosis test. CFO Brian Brown said the company expects to continue evaluating sources of capital, which may include equity or debt financings, strategic transactions and partnerships.

Impact on stocks 1

Biotech & Genomic Medicine · 1 stocks