The point-of-care test delivers PCR-accurate results in just 15 minutes, enabling healthcare providers to act quickly and prevent severe complications and onward transmission.Detects and differentiates between three types of Bordetella infection that can cause similar cough symptoms, ensuring patients receive the right diagnosis at the earliest opportunity.Early diagnosis can reduce the risk of complications and severe disease in vulnerable groups such as infants and the elderly, by enabling faster, more pr ...

Core Insights - Co-Diagnostics (Co-Dx) has entered into a definitive agreement with Arabian Eagle Manufacturing to establish a joint venture named CoMira Diagnostics for the distribution of polymerase chain reaction (PCR) platforms in Saudi Arabia and 18 other countries in the MENA region [1][2] Group 1: Joint Venture Details - The joint venture will focus on the research, development, distribution, and marketing of Co-Dx's technologies and intellectual property, including the PCR point-of-care platform [1][2] - Arabian Eagle will oversee the establishment of a manufacturing facility, manage regulatory approvals, and ensure compliance with local laws as part of the joint venture [2][4] - Co-Dx will provide the joint venture with an exclusive license to utilize, produce, and market its licensed intellectual property, which includes both the upcoming PCR platform and existing laboratory-based diagnostic products [3][6] Group 2: Market Strategy and Growth Potential - The CEO of Co-Dx emphasized the importance of this agreement in expanding healthcare innovations into a region with a significant and growing market for medical devices and point-of-care diagnostics [4][5] - The Kingdom of Saudi Arabia has identified key demand drivers that are expected to support growth in the medical diagnostics sector, which Co-Dx aims to address with its advanced PCR technology [5] - CoMira is set to initiate clinical assessments for various tests, including tuberculosis and multiplex tests for Covid-19, influenza A and B, RSV, and an 8-type HPV multiplex test by the end of the year [5] Group 3: Regulatory Considerations - The companies plan to seek regulatory clearance from the Saudi Food & Drug Administration (SFDA) to facilitate market entry across the broader territory [2][6] - The Co-Dx PCR platform, which includes the PCR Pro, PCR Home, mobile app, and associated tests, is currently pending clearance from the US Food and Drug Administration (FDA) and other regulatory authorities [6]

Financial Data and Key Metrics Changes - Total revenue for the first quarter of 2025 decreased to $100,000 from $500,000 in the same period of the prior year [17][59] - Total operating expenses decreased to $8,600,000 from $10,500,000 year-over-year [18][59] - Research and development expenses were $4,900,000 compared to $5,700,000 in the prior year [18][59] - Net loss for the first quarter was $7,500,000 or a loss of $0.24 per fully diluted share, compared to a net loss of $9,300,000 or a loss of $0.31 per fully diluted share in the prior year [18][60] - Adjusted EBITDA loss improved to $7,400,000 from $8,400,000 in the prior year [18][60] - Cash, cash equivalents, and marketable investment securities at the end of the quarter totaled $21,500,000 [19][60] Business Line Data and Key Metrics Changes - The company is advancing its CoDiEX PCR platform and associated test pipeline, focusing on tests for tuberculosis, COVID-19, a four-plex respiratory panel, and an eight-plex HPV panel [6][48] - The design for the updated COVID-19 test has been completed, and extensive verification testing has been conducted [9][49] - Progress has been made on the TB test, with preliminary analytical studies completed and instruments identified for sample preparation [10][51] - The four-plex respiratory panel is designed to deliver simultaneous PCR test results for flu A and B, COVID-19, and RSV, with significant market interest identified [11][52] - The HPV panel is being prepared for clinical evaluations, supported by a grant from the Bill and Melinda Gates Foundation [12][54] Market Data and Key Metrics Changes - The company expects to begin clinical evaluations for its TB test in India and South Africa in the latter half of 2025 [10][51] - India is identified as a top priority market for TB testing, with significant experience in regulatory, commercial, and manufacturing infrastructure through a joint venture [10][51] - The company plans to pursue regulatory clearance in India for the HPV test before expanding to South Africa and other regions [14][55] Company Strategy and Development Direction - The mission is to increase accessibility to affordable, high-quality diagnostics in the U.S., India, and globally [6][48] - The company aims to bring its Kodiak's PCR platform to market, focusing on operational and manufacturing efficiencies [8][57] - Engagement with local health officials and potential customers is ongoing to evaluate commercialization strategies [10][52] - The company is committed to achieving regulatory objectives and successfully launching the Kodiak's PCR Pro instrument and test kits [15][57] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the continued progress and future developments within the test pipeline for 2025 [19][61] - The company is focused on managing its spend to maintain a healthy balance sheet for future commercial launches [19][60] - The timeline for clinical trials is influenced by the prevalence of COVID-19, with a focus on effective testing conditions [26][68] - The company anticipates that the HPV and tuberculosis tests may enter clinical trials sooner due to the availability of samples in India [30][73] Other Important Information - The company has hosted events to build awareness of the Kodiak's PCR platform, including a symposium in India and participation in local life sciences events [14][56] - The manufacturing facility build-out in India is on track to be completed by the end of the year, enhancing regional capabilities [16][57] Q&A Session Summary Question: Timeline for COVID test resubmission - Management confirmed that the new design for the COVID test is complete, and they are preparing for clinical evaluations, with a revised submission expected to increase the probability of successful clearance [24][66] Question: Specific submission date for COVID test - The timing for submission is dependent on the prevalence of COVID-19, with management indicating it is a waiting game for effective testing conditions [26][68] Question: Timeline for other products in India and South Africa - All tests, including the multiplex ABCR test, HPV test, and TB test, are expected to enter clinical trials during the remainder of 2025 [28][70] Question: Pricing and gross margins for devices and test cups - The expected cost of the instrument is in the $300 to $500 range, with test cartridges priced at $15 to $20 in developed markets, and lower pricing for low and middle-income countries [36][79]