Co-Diagnostics, Inc. JV CoSara Receives Clearance from Indian Regulators for Influenza Multiplex PCR Test

Rhea-AI Summary

Co-Diagnostics, Inc. announces CDSCO clearance for CoSara's SARAPLEX Influenza Multiplex Test Kit, expanding CoSara's IVD test portfolio in India. The test utilizes Co-Primers technology to detect and differentiate various influenza strains, enhancing accurate PCR testing in clinical labs.

Insights

Medical Research Analyst

The clearance of CoSara Diagnostics Pvt Ltd's SARAPLEX™ Influenza Multiplex (IFM) Test Kit by the Central Drugs Standard Control Organization (CDSCO) in India represents a significant milestone in the diagnostic landscape. The ability to detect and differentiate multiple strains of Influenza A and B with a single test enhances the clinical utility and efficiency of diagnostics in high-throughput settings. This development is particularly relevant as the global healthcare infrastructure continues to adapt post-pandemic, with an increased emphasis on respiratory illness surveillance.

From a research perspective, the patented Co-Primers™ technology addresses a critical issue of primer-dimer formation in PCR tests, which can lead to false results. The technology's design mitigates these common errors, thereby potentially increasing the accuracy of the test results. This technological advancement could set a new standard for PCR tests, especially in multiplex reactions where the risk of such errors is higher.

Market Research Analyst

The authorization to sell the SARAPLEX™ IFM Test Kit in the Indian market could catalyze Co-Diagnostics, Inc.'s growth trajectory within the region. India's vast population and the need for effective diagnostic tools create a substantial market opportunity. The announcement also indicates the company's broader strategy to establish a strong foothold in emerging markets, which could be a key driver for future revenue growth.

Moreover, this development enhances CoSara's product portfolio, which already includes tests for various infectious diseases. The expansion of their diagnostic menu aligns with the growing distributor and laboratory customer base in India. As CoSara prepares to support the forthcoming Co-Dx PCR platform, its strengthened product offering and established regulatory support may provide a competitive advantage in the diagnostics sector, potentially impacting market share and investor sentiment positively.

Financial Analyst

The financial implications of the CDSCO's clearance for Co-Diagnostics' joint venture are multifaceted. In the short term, the approval may lead to an increase in sales and market penetration in India, a key emerging market. The long-term financial impact hinges on the successful adoption of the SARAPLEX™ IFM Test Kit by clinical laboratories and the subsequent rollout of the Co-Dx™ PCR Pro™ instrument. The company's growth prospects could be further bolstered by the potential FDA review of their PCR platform, indicating a strategic expansion beyond the Indian market.

Investors should consider the company's capacity to scale production, the speed of market adoption and the competitive landscape. While the news is positive, the actual financial performance will depend on execution and market dynamics. It's important to monitor the company's quarterly financial reports for sales data related to the new test kit and any updates on the FDA review process for the Co-Dx PCR platform.

The clinical laboratory real-time PCR multiplex test was designed using Co-Dx Co-Primers™ and licensed by the CDSCO for use in diagnostic procedures

SALT LAKE CITY, March 7, 2024 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that CoSara Diagnostics Pvt Ltd ("CoSara," or the "JV"), its joint venture for manufacturing and sales in India, has received clearance by the Central Drugs Standard Control Organization ("CDSCO") in India to manufacture and sell its SARAPLEX™ Influenza Multiplex (IFM) Test Kit to clinical laboratories as an in vitro diagnostic ("IVD") for the detection and differentiation of Influenza A and Influenza B.

CoSara's new real-time multiplex PCR test is built on the Company's patented Co-Primers™ technology and designed to simultaneously detect influenza A (H1N1, H3N2, H7N9, H1N2, H5N1, H2N2, H9N2, H10N8, H5N6, H7N7, H7N4, H7N2 and H2N1), influenza B (Yamagata and Victoria strains) and to differentiate between H1N1 and H3N2. Co-Primers utilize a unique design architecture to combat common issues with real-time PCR that can lead to inaccurate results, specifically primer dimer propagation, and which are magnified in multiplex reactions.

"The importance of accurate, reliable PCR testing at the high-throughput clinical laboratory level remains critical," remarked Dwight Egan, CEO of Co-Diagnostics. "We are pleased that our Co-Primers technology will help to combat respiratory illnesses in India as the world continues to adjust in the wake of the pandemic, and while we work with CoSara in preparation for playing an important role in the next stage of our Company's growth with the upcoming launch of our Co-Dx™ PCR Pro™ instrument*."

CoSara Director Mohal Sarabhai commented, "This test marks the 15^th of CoSara's clinical lab tests to receive IVD clearance by the CDSCO, and adds to our expanding menu of valuable diagnostic tools available to our growing distributor and laboratory customer base. It strengthens our foundation for future growth as CoSara also assists in the progress of point-of-care testing across India, and prepares to provide manufacturing, distribution, and regulatory support for the forthcoming Co-Dx PCR platform." 

CoSara has previously received CDSCO clearance for RT-PCR tests for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis B viral load, hepatitis C, hepatitis C viral load, HPV types 16 and 18 and HPV-HR, two COVID-19 assays, chikungunya, dengue, a dengue/chikungunya duplex test, and a Flu A/Flu B/COVID-19 ("ABC") multiplex test, all designed using the Company's patented Co-Primers technology and cleared to be manufactured and sold to clinical laboratories in the Indian market as IVDs.

*The Co-Dx PCR platform (including the PCR Home™, PCR Pro™, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale. The Co-Dx PCR Pro instrument and Co-Dx COVID-19 Test are currently under review by the FDA.

About Co-Diagnostics, Inc.:
Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies. 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 Company also uses its proprietary technology to design specific tests for its Co-Dx PCR at-home and point-of-care platform and to locate genetic markers for use in applications other than infectious disease.

Forward-Looking Statements:
This press release contains forward-looking statements. Forward-looking statements can be identified by words such as "believes," "expects," "estimates," "intends," "may," "plans," "will" and similar expressions, or the negative of these words. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances. Actual results may differ materially from those contemplated or anticipated by such forward-looking statements. Readers of this press release are cautioned not to place undue reliance on any forward-looking statements. There can be no assurance that any of the anticipated results will occur on a timely basis or at all due to certain risks and uncertainties, a discussion of which can be found in our Risk Factors disclosure in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 16, 2023, and in our other filings with the SEC. The Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.

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SOURCE Co-Diagnostics

FAQ

What is the significance of the CDSCO clearance for CoSara's SARAPLEX Influenza Multiplex Test Kit?

The CDSCO clearance allows CoSara to manufacture and sell the SARAPLEX Influenza Multiplex Test Kit for detecting and differentiating Influenza A and Influenza B in clinical laboratories in India.

How does the SARAPLEX Influenza Multiplex Test Kit utilize Co-Primers technology?

The test kit utilizes Co-Primers technology to simultaneously detect various influenza strains, combatting common issues with real-time PCR that can lead to inaccurate results.

What other tests have received CDSCO clearance by CoSara?

CoSara has received CDSCO clearance for various tests including RT-PCR tests for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis C, HPV types, COVID-19 assays, chikungunya, dengue, and Flu A/Flu B/COVID-19 multiplex test, all designed using Co-Primers technology.

What is the current status of the Co-Dx PCR platform?

The Co-Dx PCR platform, including the PCR Pro instrument and associated tests, is subject to review by regulatory bodies like the FDA and is not yet available for sale.