Co-Diagnostics reported its Q2 2023 financial results, noting a decline in COVID diagnostic kit sales but highlighted progress in expanding their PCR technology and advancements towards the FDA submission of the Co-Dx PCR Home platform.
Awarded $1.2 million from NIH under the RADx® Tech program for the upper respiratory panel on the Co-Dx PCR Home platform.
Received two grants from the Bill & Melinda Gates Foundation totaling $2.317 million for TB and HPV test development.
Signed a lease and started building a new manufacturing facility with a capacity of up to 12 production lines, with the first lines expected to be operational by the end of 2023.
Remains on track for FDA submission of the Co-Dx PCR Home platform and initial testing product by the end of the year.
The company anticipates completing development and submitting for FDA approval of the Co-Dx PCR Home platform by the end of the year, along with the expectation of having the first production lines operational in the new manufacturing facility by the same time.