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Co-Diagnostics Leveraging its CoPrimer Technology to Gain a Stronghold in the Global Diagnostics Market

05 Feb Co-Diagnostics Leveraging its CoPrimer Technology to Gain a Stronghold in the Global Diagnostics Market

Co-Diagnostics (NASDAQ: CODX), a molecular Diagnostics Company focused on developing nucleic acid molecule based reagents for diagnostic tests, announced the successful initial verification of its screening test, used for detecting the presence of the novel coronavirus. The polymerase chain reaction (PCR) screening test will soon be available for validation and distribution across the globe. The Company is using its patented platform to develop a reliable diagnostic test, which can confirm the presence of the virus with false positives or negatives.

The Company has developed the CoPrimer component of the test with the help of LGC BioSearch, which expedited the manufacturing process in view of the emerging public health crisis. The Company will keep releasing updates about the test progress, which it plans to introduce into the affected markets on a war footing.

Dwight Egan, Co-Diagnostics CEO, commented,

“After a concerted effort by Company scientists and laboratory technicians, I am pleased to report that our unique and rapid development process has culminated in a test with excellent characteristics. Our dedicated team will continue to work to perform additional verifications and preparations to quickly make the test components available to laboratories around the world, for validation with human samples.”

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.

Co-Diagnostics (NASDAQ: CODX)

Market Cap: $56.76M; Current Share Price: 2.73 USDChart
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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 7711 confirmed and 12167 suspected cases throughout the country, out of which 1370 are severe and 170 people have died, while 124 people have recovered and been discharged from hospital as per a statement from WHO. The disease which originated from the Chinese city of Wuhan, has spread to other countries with three cases being reported from France, four cases in Australia, and three cases from the U.S so far. According to the US Centers for Disease Control and Prevention (CDC), there are nearly 60 patients under observation in over 20 states in the U.S.

The WHO has declared the Coronavirus outbreak as a Public Health Emergency of International Concern (PHEIC) 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.

Co-Diagnostics develops innovative and cost-effective molecular detection tests for infectious diseases, liquid biopsy for cancer screening and agricultural applications. The Company’s advanced detection technology is enabling improved disease detection and life science research through identification of genetic material. Its patented Polymerase Chain Reaction (“PCR”) testing technology has been commercialized to quickly develop novel and cost-efficient molecular diagnostic tests that offer improvements over existing conventional methods.

The technology has broad applications in areas such as multiplexing, single nucleotide polymorphism (SNP) and mutation detection, real-time or traditional PCR detection, genotyping, RNA expression, and Sanger or next generation sequencing as per the Company. The Company intends to explore the application of its patented technology in numerous disciplines like infectious disease, oncology, transfusion medicine, pharmacogenetics, therapeutics, liquid biopsy, agriculture, or veterinary medicine.

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The technology enables researchers to quantify and analyze rare alleles and mutations, including unique, accelerated, ultra-specific attributes. The platform is increasingly adopted by leading companies to improve the accuracy of their next generation sequencing and offer multiple advantages such as reduced costs, improved speeds, higher productivity and most importantly accurate detection and amplification of genetic materials.

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.

Risk Assessment

  • The Company is focused on addressing large unmet needs in markets around the world. For instance it set up one of the largest private molecular diagnostics laboratories in Ghana, in its quest to boost the sales of its vector control mosquito tests. In addition Co-Diagnostics has established a joint venture in India to provide impetus to the sales of its primers and other testing components, besides sales for IVD, once regulatory approval is received. The Company has established a strong network of laboratories and distributors for ordering tests such as tuberculosis, malaria, hepatitis B, hepatitis C and human papillomavirus as per the Company.
  • Co-Diagnostic is developing a robust pipeline of vector control products, which includes a test for West Nile, western equine encephalitis, St. Louis encephalitis, Zika, dengue and chikungunya viruses. The Company is anticipating the launch of its NAM-e triplex test, the only test of its kind that can detect the virulent EEE (eastern equine encephalitis).
  • The Company is also forging strategic partnerships with Companies in the AgBio sector such as its agreement with LGC, Biosearch Technologies, a world leader in sophisticated, custom oligonucleotide-based tools and associated reagents, which has a footprint in over 200 countries.
  • Co-Diagnostic is developing a diverse pipeline of candidates based primarily on the demands of the market, leveraging its CoPrimer real-time qPCR platform to create highly specific multiplex assays that can be used in areas such as identifying different cancer mutations, using an effective, cost-efficient diagnostic tool. This provides an excellent opportunity for diversification and opens up licensing and partnership avenues.
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    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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