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3 Diagnostic Companies Riding the Wave of Pandemic

12 Jan 3 Diagnostic Companies Riding the Wave of Pandemic

The Pandemic has had a tremendous impact on the Diagnostics Industry, with increased demand for stringent testing across the world. According to a report by Research and Markets, the Global in-vitro diagnostics market is expected to reach USD 96.0 billion by 2025, growing at a CAGR of 2.6% from USD 84.5 billion in 2020.

The pandemic will drive the growth in the market as the world looks to opening up its markets and other institutions to public. The vaccines may not make a great dent on the run of these diagnostic companies as testing would still be needed to establish full efficacy of the vaccinations being administered. We take a look at three such Companies that have leveraged their novel technology platforms to take the pandemic head-on.

Meridian Bioscience, Inc. (NASDAQ: VIVO)

Market Cap: $948.28M; Current Share Price: 21.99 USDChart
Data by YCharts

Meridian Bioscience Inc, a Company developing diagnostic test kits for gastrointestinal and respiratory infectious diseases and and elevated blood lead levels, through its Diagnostics and Life Science businesses, announced that its preliminary first quarter revenue results for Fiscal 2021, exceeded expectations. The Life Sciences segment of the Company witnessed great demand for its COVID-19 related products, bringing in estimated revenue of $92 million, compared to $47.4 million in the first quarter of fiscal 2020, an impressive growth of nearly 94%.

Meridian is upbeat about the demand remaining strong even in the second quarter of fiscal 2021 owing to the pandemic continuing unabated and new mutations being detected. On the other hand its diagnostics business is expected to remain flat with revenue of close to $30 million, as it experienced a slowdown due to rising number of COVID-19 cases and stringent lockdowns.

In December 2020, the Company had received approximately $1M funding from the National Institute of Health (NIH) Rapid Acceleration of Diagnostics (RADxSM) initiative for its SARS-CoV-2 molecular diagnostic test on the Revogene® platform. Meridian submitted an application for Emergency Use Authorization (EUA) for the Revogene® SARS-CoV-2 assay on 7 December 2020.

The Revogene brand offers real-time PCR amplification, while its Alethia brand provides isothermal DNA amplification. Furthermore it has other brands offering a wide array of tests such as Curian, which offers lateral flow immunoassay using fluorescent chemistry and ImmunoCard and ImmunoCard STAT! that provides rapid immunoassay to name a few. In addition the Company also develops gastrointestinal assays, respiratory illness assays and blood chemistry assays.

The Life Sciences division of the Company caters to the in vitro diagnostic manufacturers and researchers in form of PCR/qPCR reagents, antigens, antibodies and nucleotides etc. Recently Meridian launched an Air-Dryable RT-qPCR Mix that has greatly simplified the development of COVID-19 molecular assays. In addition, to eliminating the need for cold chain shipping and storage, it is also cost effective and easy to use.

Co-Diagnostics, Inc (NASDAQ: CODX)

Market Cap: $295.70M; Current Share Price: 10.46 USDChart
Data by YCharts

In December 2020, Co-Diagnostics Inc, a molecular Diagnostics Company focused on developing nucleic acid molecule based reagents for diagnostic tests, announced the sale of more than 10 million of its Logix Smart™ COVID-19 Test Kits to its extensive network of laboratories, hospitals, and distributors worldwide. Furthermore it is also anticipating strong revenue in Q4 2020, which will most likely exceed the revenue of $21.82 million from its Q3 2020, by at least 20-25% according to analysts.

The Company had launched 3 pivotal COVID-19 tests in 2020 and has received regulatory approvals for in vitro diagnostics for Flu A/Flu B/COVID-19, a SARS-CoV-2 2-gene multiplex test, and a multiplex test for Zika/dengue/chikungunya. In addition, it also has vector control multiplex products for testing mosquito populations and is working on a liquid biopsy and next-gen sequencing ag-bio applications.

Image Source: Company

Co-Diagnostics Proprietary technology and development process enables it to develop tests with sensitivity and specificity in a very short period of time. In addition the process also allows it to save on development costs as well as licensing fees, by leveraging its patented technology. The resultant products are affordable and easy accessible for markets around the world.

The Company’s patented CoPrimers Technology is capable of dramatically enhancing the performance of molecular diagnostic tests conducted via real-time polymerase chain reaction (“PCR”) tests. The unique structure of the CoPrimer makes generates far more specific reactions when compared to other PCR technologies. They are deemed to be 2.5 MILLION times more effective in reducing amplification errors, according to the Journal of Molecular Diagnostics.

The Company has entered into strategic collaborations such as with Asence Inc, which has a joint venture agreement with Synbiotics Ltd, a group company of Asence Inc. for manufacturing.

In addition the Company has granted exclusive manufacturing rights to CoSara in India, and has a one-of-its-kind 2,500 sq ft Good Manufacturing Practices (GMP) facility in Ranoli India, for making in vitro diagnostics designated for clinical use. The joint venture has already received CDSCO clearance for RT-PCR tests for COVID-19, a SARS-CoV-2 (2-gene multiplex test), Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis C and human papillomavirus (HPV) for sale in the Indian market.

GenMark Diagnostics Inc (NASDAQ: GNMK)

Market Cap: $1.11B; Current Share Price: 15.48 USDChart
Data by YCharts

GenMark Diagnostics Inc, a Company developing molecular diagnostic tests based on its proprietary eSensor electrochemical detection technology, announced its preliminary operational and financial results that anticipate its total revenue to be at $171 million, an increase of nearly 95% over 2019. The revenue from ePlex® is likely to grow by 155% over 2019 to reach approximately $152 million. The Company has multi-year contracts that add a valuable recurring revenue stream with their committed volumes. GenMark has installed 70 new ePlex analyzers in Q4, 2020, closing the year with an installed base of 792 ePlex analyzers, a growth of 50% year over year.

GenMark Diagnostics, formerly known as Osmetech, is a pioneer in molecular diagnostics. The Company’s ePlex true sample-to-answer system is an amalgamation of leading-edge eSensor technology, with digital microfluidics, which offers an improvement over the limitations in the current laboratory systems. ePlex offers comprehensive diagnostic workflow solutions that helps redirect the focus to patient care, reduce costs, and increase lab efficiency. The Company’s eSensor technology uses the principles of competitive DNA hybridization and electrochemical detection eliminating contamination risk and reducing preparation times.

The Company’s product offerings consist of its ePlex System that enables improved efficiency by leveraging its rapid, multiplex molecular diagnostics capabilities. The system has features such as template comments, laboratory information system (LIS), Security and User management and report scheduler to name a few. Furthermore it offers scalability owing to its modular nature, providing five different instrument configurations that range from 3 to 24 test days. The system also helps eliminate any biases and errors in identity checking and order transcription.

Additionally, the Company manufactures the XT-8 system, a multiplex molecular testing that enables post-PCR detection of infectious disease, genetics, and pharmacogenetics targets. Some of the features offered by the system include simplicity, scalability and versatility.

GenMark provides a range of multiplex panels such as the Respiratory Pathogen panel and Blood Culture Identification panels. The Company is currently engaged in developing products designed to address the needs in the infectious diseases market namely a Central Nervous System panel and Gastrointestinal Pathogen panel.

In March 2020, the FDA had given the Company’s ePlex SARS-CoV-2 Test an emergency use authorization. The technology addresses a very important need for quick and easy detection of COVID-19, and has a global installed user base of more than 500 analyzers as of December 31, 2019. GenMark received $749,000 in funding from the Biomedical Advanced Research and Development Authority (BARDA) for developing a diagnostic panel that incorporates the new SARS-CoV-2 viral target into the company’s existing ePlex Respiratory Pathogen (RP) panel.

The ePlex SARS-CoV-2 Test is designed exclusively for use on the company’s ePlex system, to test nasopharyngeal swab (NPS) specimens of suspected patients, and offers results in less than 2 hours, through an automated diagnostic process. The system has the capacity to process up to 96 tests per 8-hour shift. In addition, the system’s expandable design allows for near-patient testing and can be widely accessed by laboratories of any scale and size.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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References

https://investor.meridianbioscience.com/news-releases/news-release-details/meridian-bioscience-announces-better-expected-preliminary-first

https://www.globenewswire.com/news-release/2020/12/16/2146493/0/en/Meridian-Bioscience-receives-NIH-Award-for-supporting-rapid-development-of-Revogene-molecular-test-for-SARS-CoV-2.html

https://www.prnewswire.com/news-releases/co-diagnostics-anticipates-reporting-highest-quarterly-revenue-following-demand-for-covid-19-diagnostic-products-301201825.html

https://www.prnewswire.com/news-releases/co-diagnostics-announces-milestone-of-over-10-million-covid-19-tests-sold-301191945.html

https://www.globenewswire.com/news-release/2021/01/11/2156610/0/en/GenMark-Diagnostics-Provides-Preliminary-Operational-and-Financial-Results-for-2020.html

https://ir.genmarkdx.com/news-releases/news-release-details/genmark-awarded-barda-grant-development-eplexr-rp2-panel

https://codiagnostics.com/technology/coprimers/

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