The ongoing pandemic of the coronavirus disease 2019 (COVID-19) is caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Shockingly and unexpectedly, COVID-19 has been reported in more than 7.4 million individuals worldwide as of June 11, 2020. As of now, there are at least 417,700 dead because of this virus.
Even though this colossal public health crisis presents an unprecedented challenge for detecting the virus in question, there is still hope to eradicate this deadly contagion from our society. Fortunately, due to modern sequencing technologies and global collaboration, the complete genomic sequence of SARS-CoV-2 (see depiction of the virus and its proteins below1) was available in public domain within a few weeks of the realization that this virus could cause havoc at a scale that has never been seen before.
Given the rapid pace of scientific discovery, genomic sequence data, and clinical data generated by analyzing the large number of people rapidly infected by SARS-CoV-2, clinicians need accurate and precise methods todetect the virus. Diagnostic testing to identify people who are infected with the SARS-CoV-2 infection is central to control the global pandemic of COVID-19.
This would be immensely important to initiate triaging of affected patients to contain the disease and to immediately begin effective medical treatments. This is why the use of diagnostic testing on a massive scale is a cornerstone of successful containment strategies.
What Baylor Genetics is Doing to Help?
It has been reported that many states in the U.S. are significantly behind in the ability to perform the CDC’s recommended level of testing.2 Baylor Genetics (BG), with its leadership position in genomic diagnostic space and a rich history of over four decades in diagnostic testing, decided to help in elimination of this deadly disease. This decision was emphatically made as we felt it is our moral and ethical obligation to provide this crucial social contribution in these difficult times.
Moreover, due to our existing large-scale and high-throughput capabilities, we are able to deliver thousands of tests per day. Additionally, we have the scientific and technical know-how to expand this to millions of tests per day using newer technologies when needed. This type of mega-scale testing and surveillance to detect and eradicate the COVID-19 menace is enormously vital. Innovation is in BG’s DNA.
As a phase-1 approach, BG rapidly validated a RT-PCR (real-time reverse transcription polymerase chain reaction) based assay performed on respiratory specimens from individuals. This test performed in CLIA-certified, CAP–accredited laboratory has been validated and is operated under FDA guidelines.
Main features of Baylor Genetics COVID-19 (SARS-CoV-2) RT-PCR Test:
- Indications for Testing:
- The CDC has issued a guidance for indications for SARS-CoV-2 testing, Overview of Testing for SARS-CoV-2, which include patients with fever and/or symptoms of acute respiratory illness (e.g. cough, difficulty breathing).
- Epidemiologic factors, such as known exposure to an individual who has tested positive for SARS-CoV-2 and the occurrence of local community transmission or transmission within a specific setting/facility (e.g. nursing homes) should also be considered.
- Sample Types:
- Intended for the qualitative detection of nucleic acid (RNA) from SARS-CoV-2 in nasal, nasopharyngeal (NP), or oropharyngeal (OP) swab specimens from patients suspected of COVID-19 by their healthcare provider.
- Turnaround Time:
- The results from this test are available within 24-48 hours.
Conclusions
Urgent clinical and public health needs currently drive an unprecedented global effort to increase testing capacity for SARS-CoV-2 infection. Because of that, Baylor Genetics has launched our viral RNA testing. We will continue to innovate to add new tests to our COVID-19 testing repertoire to help not only diagnostic testing, but to contribute to growing body of scientific and clinical knowledge.
While availability of rapid, large scale testing capabilities is certainly encouraging, there’s much more work to do. It will be important to explore technologies like NGS (Next–Generation Sequencing) to not only expand the scale exponentially but also to identify different strains of the virus to facilitate epidemiological studies and to enable prevention of future outbreaks.
It also will be critical to find out how we could use neutralizing antibody tests in an effective and reliable way to monitor the response of treatment, establishment of immunity and to see how the expected vaccination would work.
While we await those answers, it is reassuring that we continue to learn about COVID-19 each day and use that knowledge to continue to innovate. Please visit our website frequently for newer offerings to aid and abate COVID-19 from our society: www.baylorgenetics.com/covid-19-testing
References:
- 1. N Engl J Med 2020; 382:2261-2264 DOI: 10.1056/NEJMcibr2007042
- 2. https://www.houstonchronicle.com/news/houston-texas/houston/article/coronavirus-live-update-case-us-2020-death-numbers-15201833.php
- 3. https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html
