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GenMark’s ePlex SARS-CoV-2 Test proves an important ally in the Fight against COVID-19

24 Mar GenMark’s ePlex SARS-CoV-2 Test proves an important ally in the Fight against COVID-19

GenMark Diagnostics (NASDAQ: GNMK), a Company developing molecular diagnostic tests based on its proprietary eSensor electrochemical detection technology, announced that the FDA has 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.

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.

GenMark Diagnostics (NASDAQ: GNMK)

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Scott Mendel, Interim Chief Executive Officer of GenMark, commented,

“Because ePlex enables near-patient testing and is available in hospitals and labs across the United States and in more than 30 countries, results can be returned to doctors and patients more rapidly than with other platforms. Our unique ability to quickly diagnose and begin treatment of critically ill patients addresses the challenges associated with the coronavirus pandemic. We are proud of our team’s ability to rapidly respond to this urgent public health crisis. The FDA’s Emergency Use Authorization of our test supports GenMark’s commitment to provide critical and actionable diagnostic information to healthcare providers so that they can better manage their patients.”

The Company is one of the first to commercialize its test and has so far supplied nearly ten thousand tests to customers since March, as per a Company statement. GenMark is trying to scale up its manufacturing capacity to meet the additional needs.

Industry
According to the World Health Organization (WHO), Coronovirus (CoV) is a family of viruses that cause illnesses ranging from common cold to lethal diseases such as the Middle East Respiratory Syndrome (MERS-CoV), Severe Acute Respiratory Syndrome (SARS-CoV) and a new strain of CoV named, novel coronavirus (nCoV). The virus is Zoonotic as they are transmitted from animals to humans, with there being many known strains that have not yet infected humans. The infection manifests in the form of respiratory symptoms, cough, fever, shortness of breath and can take the form of pneumonia, severe acute respiratory syndrome, kidney failure and even death.

WHO had identified a new type of coronavirus, namely 2019 novel coronavirus (2019-nCoV) in China in early January 2020, which has so far infected 209,839 cases globally and fatalities were 8778 as per WHO. The disease which originated from the Chinese city of Wuhan, has spread to 168 countries, areas and territories. According to the US Centers for Disease Control and Prevention (CDC), there are 14,200 known cases across 39 states and 205 people have died so far in the U.S alone.

The WHO has declared the Coronavirus outbreak as a Public Health Emergency of International Concern (PHEIC) and a global pandemic as more cases are reported around the world as the virus continues to spread beyond Wuhan. China. The notice allows members of the United Nations to take preemptive measures to contain the spread of the virus, including measures such as sealing borders, cancelling flights, proactively screen and quarantine suspected cases etc. Hong Kong has declared the highest level of citywide emergency, while China has cancelled its Chinese New Year Celebrations, declared school breaks and placed travel restriction in order to curb the spread of the disease.

There is no definite cure for treatment or eradication of CoV, with treatment being limited to alleviation of symptoms, and providing support and care to patients. Scientists have been able to sequence the virus genetic code; spurring organizations around the world into action, with the researchers at the US National Institutes of Health are already working on a therapeutic. Organizations like CEPI are supporting initiatives to develop a vaccine by proving funding support.

Company
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 theXT-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.

Image Source: Company

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.

Image Source: Company

Risk Assessment

  • The Company caters to a wide variety of clinical needs such as molecular panels for central nervous system (CNS) infections to detect Meningitis and encephalitis, gastrointestinal infections, genetic conditions like cystic fibrosis, inherited thrombophilia and warfarin sensitivity. A diversified product line augurs well for the Company by mitigating risks and multiplying opportunities.
  • As Coronavirus reaches epidemic proportions in countries around the world, there is a great demand for a rapid and reliable testing system. Though the Company may face competition from other diagnostic companies such as Co-Diagnostics (NASDAQ: CODX), the immediate demand is likely to be extremely high.
  • GenMark is slowly but steadily gaining a foothold in the market, with over 70 percent of its placements in the Q4, 2019 were in laboratories that were previously using competitive analyzer. The Company also placed 38 new ePlex analyzers in the same quarter, taking its total installed base to 527.
  • As per it full year guidance for 2020, the Company expects its ePlex placements to be in the range of 130 to 160 net new analyzers with an annuity per analyzer between $130,000 and $135,000. In addition, GenMark expects its revenues to be in the range of $100 million to $110 million as per the Company’s latest financial results.
  • 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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    Source

    https://www.genmarkdx.com/solutions/systems/xt-8-system/

    https://www.usatoday.com/story/news/health/2020/03/19/coronavirus-updates-us-china-nyc-cases-testing-unemployment-cdc/2866751001/

    https://www.usatoday.com/story/news/health/2020/03/19/coronavirus-updates-us-china-nyc-cases-testing-unemployment-cdc/2866751001/

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