Core Insights - DiagnosTear Technologies Inc. announced promising interim results from its multi-center clinical study in Israel for the TeaRx™ Red Eye diagnostic platform, aimed at improving ocular diagnostics [1][6] Company Overview - DiagnosTear Technologies Inc. is a leader in rapid, point-of-care diagnostics for ocular diseases, focusing on multi-parametric tests that provide actionable insights based on tear-fluid analysis [8] Product Development - The TeaRx™ Red Eye device is designed to differentiate between three types of red eye conditions: Adenoviral conjunctivitis, Herpetic keratitis, and Allergic conjunctivitis, which collectively lead to millions of clinic visits annually [2][6] - The device addresses the current lack of rapid diagnostics, which contributes to misdiagnosis and inappropriate treatments [2] Clinical Study Details - The Israeli clinical program began in October 2023 and involves multiple leading health facilities, enrolling patients with suspected red eye conditions [3] - The study has recruited 130 subjects, with 66 samples evaluated for adenovirus, 60 for HSV-1/2, and 61 for total tear IgE [5] Interim Results - The TeaRx™ Red Eye assay showed high agreement rates: 92% positive and 100% negative for Adenovirus, 100% for HSV-1/2, and 73% positive and 93% negative for total tear IgE compared to reference methods [5] - These results indicate the device's reliability in identifying viral causes of red eye, which can lead to better point-of-care decisions [5][6] Future Plans - The Israeli study is expected to conclude by Q2 2026, with additional clinical programs in India and France also targeting completion by the same timeframe [6] - The company aims to compile a comprehensive dataset from these studies to support regulatory submissions and global commercialization of the TeaRx™ Red Eye [7]

Core Insights - Roche has received FDA 510(k) clearance and CLIA waiver for its first point-of-care test for whooping cough and Bordetella infections, which provides results in just 15 minutes [1][3] - The test can differentiate between three Bordetella species, allowing for more accurate diagnoses and timely treatment [3][8] - The rise in whooping cough cases is attributed to pandemic-related vaccination interruptions, waning immunity, and vaccine hesitancy, affecting all age groups [4][5] Company Overview - Roche, founded in 1896, is the world's largest biotechnology company and a leader in in-vitro diagnostics, focusing on scientific excellence to improve healthcare [7] - The cobas® liat system, used for the new test, is already established in point-of-care diagnostics and enhances the speed and accuracy of clinical decisions [6][8] - Roche is committed to sustainability and aims to achieve net zero by 2045, reflecting its long-standing dedication to societal contributions through innovative healthcare solutions [9]

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]