In recent weeks, we’ve seen further advances in the molecular diagnostic sector’s response to the COVID-19 pandemic. Labs are scaling to meet the demand for more testing, and the FDA has provided emergency authorization for new types of tests. The sector also continues to push forward with new cancer tests that will have a significant impact on patient outcomes.
COVID-19 Testing & Capacity
At the end of July, Helix announced that they had been selected by the National Institutes of Health (NIH) to become one of the nation’s COVID-19 “Mega-Labs.” For Helix, this means $33.4 million in funding to support scaling its daily COVID-19 testing capacity. The company has also been given FDA Emergency Use Authorization (EUA) for its next generation sequencing (NGS)-based COVID-19 test, one of the first COVID-19 tests based on sequencing, which will help it meet its goal of 100,000 tests a day by the fall. According to a company spokesperson, this will make it “one of the country’s highest-throughput COVID-19 labs.”
Adaptive Biotechnologies has launched immunoSEQ® T-MAP™ COVID. This is a research product and data analysis service that can measure the T-cell immune response to vaccines in development and track the persistence of that response over time. Knowledge of what drives our immune response to COVID-19 is critical to understanding the potential efficacy of vaccines under development and will help advance global efforts to control the outbreak.
The Jackson Laboratory (JAX) announced that it is collaborating with Yale on the broad implementation of a new saliva-based COVID-19 test. The test, developed by researchers at the Yale School of Public Health, is simpler, less expensive, and less invasive than the nasal-swab test. The FDA has already granted it an EUA, but JAX will help make it more widely accessible.
India is one of many countries with a large population struggling to contain the COVID-19 virus. As of August 13, there were almost 2.4 million cases of the virus across the country. Just a month later, that number has jumped to more than 4.9 million—the second-highest number of cases in a country worldwide.* In efforts to slow the progression, Illumina is collaborating with the Institute of Genomics & Integrative Biology (IGIB), a premier Institute of Council of Scientific and Industrial Research (CSIR), to provide next generation sequencing for COVID-19 testing and to expand testing capacity.
Lastly, the Belgian National Reference Testing Center has published an article in the Journal of the American Medical Informatics Association, outlining the design, implementation, and requirements of laboratory information system (LIS) functionality related to managing COVID-19 testing. The clear takeaways of their research are that “IT solutions could effectively reduce administrative burden and streamline sample flow, resulting in higher staff engagement and reduced turnaround times.” We highly recommend you read this detailed research to better understand the key bottlenecks to effective lab management.
Guardant Health reports that they have received FDA approval for Guardant360 CDx, the company’s targeted next-generation sequencing liquid biopsy assay. In a statement, Guardant CEO Helmy Eltoukhy said the FDA approval “will help accelerate wider adoption of guideline-recommended genomic profiling, increase the number of advanced cancer patients who receive potentially life-changing treatments, and pave the way for new companion diagnostic developments.” That’s fantastic news for patients and the healthcare providers who care for them.
Also in cancer testing news, the FDA has approved Foundation Medicine’s FoundationOne Liquid CDx. This multi-cancer comprehensive liquid-biopsy test covers more than 300 cancer-related genes, including those related to prostate and lung cancer, and helps guide clinicians in the use of immunotherapies.
Illumina’s recent acquisition of GRAIL is also newsworthy. GRAIL, which was originally founded by Illumina in 2016 and then spun into a standalone company, is focused on early cancer detection. Illumina plans to use its global scale, manufacturing, and clinical capabilities to accelerate the adoption of GRAIL’s multi-cancer detection test, GalleriTM, to reach more patients faster. According to the news release, the test is capable of detecting “more than 50 cancer types, over 45 of which have no recommended screening in the United States.”
Universally, the industry is keenly focused on the COVID-19 pandemic. Public pressure is mounting for testing that is faster, more accurate, and more available. Laboratories that have the IT infrastructure to scale are in a better position to respond and have more bandwidth to develop innovative new solutions related to the virus and in other areas.
If you want to talk about how software can help you grow your lab, contact us today.
*As of September 15, 2020.