Co-Diagnostics Inc
NASDAQ:CODX
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Co-Diagnostics Inc
NASDAQ:CODX
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Co-Diagnostics Inc
Co-Diagnostics, Inc. engages in the development and innovation of molecular tools for detection of infectious diseases, liquid biopsy for cancer screening, and agricultural applications. The company is headquartered in Salt Lake City, Utah and currently employs 115 full-time employees. The company went IPO on 2017-07-12. The Company’s technologies are utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The firm also uses its proprietary technology to design specific tests for its Co-Dx PCR platform and to locate genetic markers for use in applications other than infectious disease. Its diagnostics systems enable dependable, low-cost, molecular testing for organisms and genetic diseases by automating or simplifying historically complex procedures in both the development and administration of tests. The company is developing a portable diagnostic device and test system designed for point-of-care and at-home use. The system consists of its PCR instrument that it refers to as the Co-Dx PCR Pro instrument, its proprietary diagnostic test cup system and a mobile application to be installed on the user’s mobile device.
Co-Diagnostics, Inc. engages in the development and innovation of molecular tools for detection of infectious diseases, liquid biopsy for cancer screening, and agricultural applications. The company is headquartered in Salt Lake City, Utah and currently employs 115 full-time employees. The company went IPO on 2017-07-12. The Company’s technologies are utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The firm also uses its proprietary technology to design specific tests for its Co-Dx PCR platform and to locate genetic markers for use in applications other than infectious disease. Its diagnostics systems enable dependable, low-cost, molecular testing for organisms and genetic diseases by automating or simplifying historically complex procedures in both the development and administration of tests. The company is developing a portable diagnostic device and test system designed for point-of-care and at-home use. The system consists of its PCR instrument that it refers to as the Co-Dx PCR Pro instrument, its proprietary diagnostic test cup system and a mobile application to be installed on the user’s mobile device.
Regulatory milestone: Co-Diagnostics said it submitted a dual 510(k) and CLIA waiver application to the FDA for its flu A, B and RSV assay, calling it a major step toward U.S. commercialization.
TB progress: The company said tuberculosis studies in India are advancing and it still expects additional regulatory submissions later this year, including to India's CDSCO and potentially WHO's ERPD.
Costs down: Total operating expenses fell to $6.3 million from $8.2 million a year ago, helped by lower legal, personnel and stock-based compensation costs.
Cash position: The company ended the quarter with $3.6 million in cash and said it may look at equity, debt, partnerships or grants to fund ongoing work.
Platform expansion: Management highlighted progress beyond respiratory testing, including Ebola proof-of-concept work, cloud connectivity, AI-enabled capabilities and a broader manufacturing build-out in Saudi Arabia and India.