Co-Diagnostics Inc
OTC: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 101 full-time employees. The company went IPO on 2017-07-12. The firm is engaged in developing, manufacturing and marketing diagnostics technology. Its reagents are used for diagnostic tests that function via the detection and/or analysis of nucleic acid molecules, such as deoxyribonucleic acid and ribonucleic acid. The company also sells diagnostic equipment from other manufacturers as self-contained lab systems (MDx device). The firm uses its proprietary test design system and proprietary reagents to design and sell polymerase chain reaction diagnostic tests for diseases and pathogens starting with tests for tuberculosis, a drug resistant tuberculosis test, hepatitis B and C, Malaria, dengue, human immunodeficiency virus and Zika virus, all of which tests have been designed and validated in its laboratory. Its diagnostics systems enable molecular testing for organisms and genetic diseases by automating historically complex procedures in both the development and administration of tests.
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 101 full-time employees. The company went IPO on 2017-07-12. The firm is engaged in developing, manufacturing and marketing diagnostics technology. Its reagents are used for diagnostic tests that function via the detection and/or analysis of nucleic acid molecules, such as deoxyribonucleic acid and ribonucleic acid. The company also sells diagnostic equipment from other manufacturers as self-contained lab systems (MDx device). The firm uses its proprietary test design system and proprietary reagents to design and sell polymerase chain reaction diagnostic tests for diseases and pathogens starting with tests for tuberculosis, a drug resistant tuberculosis test, hepatitis B and C, Malaria, dengue, human immunodeficiency virus and Zika virus, all of which tests have been designed and validated in its laboratory. Its diagnostics systems enable molecular testing for organisms and genetic diseases by automating historically complex procedures in both the development and administration of tests.
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.
