SALT LAKE CITY - Co-Diagnostics , Inc. (NASDAQ:CODX), a molecular diagnostics company, announced today that its joint venture in India, CoSara Diagnostics Pvt Ltd, has received regulatory clearance to manufacture and sell its SARAPLEX Influenza Multiplex Test Kit. The Central Drugs Standard Control Organization (CDSCO) in India has approved the test kit for clinical laboratory use as an in vitro diagnostic tool for detecting and differentiating Influenza A and B.
The test, utilizing Co-Diagnostics' patented Co-Primers technology, is designed to detect various strains of influenza A and B and differentiate between H1N1 and H3N2. This technology aims to address common issues with real-time PCR testing, such as primer dimer propagation, which can lead to inaccurate results, especially in multiplex reactions.
Dwight Egan, CEO of Co-Diagnostics, emphasized the importance of accurate PCR testing for respiratory illnesses in India, highlighting the role of the company's technology in addressing health challenges post-pandemic. CoSara's Director, Mohal Sarabhai, added that this approval marks the 15th IVD clearance for CoSara's clinical lab tests in India, contributing to the company's growth and supporting the advancement of point-of-care testing throughout the country.
Previously, CoSara has received CDSCO clearance for a range of RT-PCR tests, including those for tuberculosis, malaria, hepatitis, HPV, and COVID-19, all designed using Co-Primers technology.
The announcement also mentioned the upcoming Co-Dx PCR Pro instrument, which is part of the company's Co-Dx PCR platform. This platform, including a mobile app and associated tests, is currently under regulatory review and not yet available for sale.
The information in this article is based on a press release statement from Co-Diagnostics, Inc.
InvestingPro Insights
As Co-Diagnostics, Inc. (NASDAQ:CODX) continues to make strides in the medical diagnostics field, particularly with its recent regulatory clearance in India, investors may be eyeing the company's financial health and market performance. According to InvestingPro data, Co-Diagnostics holds a market capitalization of 35.47 million USD, reflecting its size and market value within the biotechnology industry. However, the company's P/E ratio stands at -0.78, indicating that the market currently does not expect earnings growth. This is further emphasized by an adjusted P/E ratio over the last twelve months as of Q3 2023, which has declined to -1.11.
Despite the challenges, two notable InvestingPro Tips suggest a mixed financial landscape for Co-Diagnostics. On the one hand, management's aggressive share buyback strategy could be a sign of confidence in the company's future prospects. On the other hand, analysts are concerned with the company's cash burn rate and anticipate a sales decline in the current year, which could impact the stock's performance. Furthermore, the company holds more cash than debt on its balance sheet, which may provide some financial stability amidst the expected sales decline.
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