OPKO Health Inc.’s OPK BioReference Laboratories, Inc. recently announced that it has started accepting specimens for a new multiplex COVID-19 and influenza test, which can be utilized by healthcare providers, clinics and health systems across the United States. This test will help in the diagnosis of COVID-19 and Influenza A or B (flu).
It is worth mentioning that with respect to COVID-19 response efforts, the company built a specific expertise in offering testing with reasonable turnaround times. BioReference has been chosen to offer testing services by the Centers for Disease Control and Prevention (CDC) to various states, cities and large healthcare systems, multiple drive-through around the United States, urgent care centers, and several important professional sports organizations.
This test is likely to provide a boost to the company’s Diagnostics segment.
Significance of the Multiplex Test
It is crucial to differentiate between COVID-19 and Influenza A or B infection(s), as symptoms of seasonal respiratory infections and COVID-19 can be similar. The test offered by BioReference Laboratories will use a single sample to identify the aforementioned. This, in turn, will enable rapid diagnosis and offer surveillance for flu and COVID-19, while conserving critical testing samples.
Notably, the multiplex test can be performed on healthcare provider-collected nasal and nasopharyngeal swab specimens, and self-collected nasal swab specimens collected in a healthcare setting overseen by a healthcare provider.
Per a report published on Grand View Research, the global molecular diagnostics market was valued at $9.2 billion in 2019 and is expected to reach $18.2 billion by 2027, witnessing a CAGR of 9% between 2020 and 2027. Factors like technological advancements in molecular diagnostics and the rising prevalence of infectious diseases are likely to drive the market.
Hence, the latest development is a well-timed one for OPKO Health.
Recently, BioReference Laboratories announced the commencement of its COVID-19 testing program for New York City schools throughout the entire 2020-2021 school year. This initiative will help in creating a safer school environment.
In September, BioReference Laboratories and its specialty oncology division, GenPath, launched OnkoSight Advanced. It is a next-generation sequencing (NGS) assay that facilitates revolutionary deoxyribonucleic acid (DNA) mutational profiling of tumor samples.
There are other players in the MedTech space that have made significant progress in the field of diagnostic testing and continue to do so. One of them being Quest Diagnostics Incorporated DGX, which has come up with a three-in-one single swab test in September. With the flu season approaching, this combined test launch for COVID-19 and other respiratory viruses is of upmost importance. According to the company, nearly 20 viral and bacterial infections can be identified from a single swab, reducing time for diagnosis and treatment.
Another MedTech player is Becton, Dickinson and Company BDX — also popularly known as BD – recently received CE mark for its rapid, point-of-care, SARS-CoV-2 antigen test for utilization on the BD Veritor Plus System. The new test brings in substantial improvement in turnaround time for COVID-19 diagnostics as it offers real-time results and helps to make decisions while the patient is still onsite. Notably, the company anticipates this new assay to be commercially available by October-end for countries in Europe that recognize the CE mark.
Further, this month, Abbott Laboratories ABT announced the receipt of the FDA’s Emergency Use Authorization (“EUA”) for its AdviseDx SARS-CoV-2 IgM (Immunoglobulin M) lab-based serology test. Notably, the test will be used on the company’s ARCHITECT and Alinity platforms. Notably, the AdviseDx SARS-CoV-2 IgM test is the second antibody test being offered by Abbott after its launch of the IgG antibody test in April. Moreover, the company has received EUAs for seven tests since the beginning of the pandemic, including molecular tests, a rapid antigen test and the IgG antibody test.
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