CAMBRIDGE, Mass., Oct. 29, 2020 /PRNewswire/ -- LabCentral, the first-of-its-kind shared laboratory space designed as a launchpad for high-potential biotech startups, today announced it has partnered with BioLabs and E25Bio to launch the Cambridge Consortium for Rapid COVID-19 Tests (CCRCT). The goal of this new testing initiative is to combine resources and validate fast, affordable diagnostic assays to provide SARS-CoV-2 screening for asymptomatic populations as part of a strategy for safely returning to work, school or other aspects of daily life.
The current gold standard for diagnosis of a SARS-CoV-2 infection is a real time-polymerase chain reaction (RT-PCR). This diagnostic method is time-consuming and dependent on expensive instrumentation and trained technicians to perform both the sample collection and assay. While PCR results may be available within 24 hours, turnaround times can sometimes take several days to a week.
The CCRCT is conducting a clinical trial to validate a novel SARS-CoV-2 Direct Antigen Rapid Test, known as "DART." Developed by LabCentral alumnus E25Bio, a pioneer in rapid diagnostic tests for fever viruses, DART is a self-administered, at-home test that can produce results within 15 minutes. DART is an immunoassay for qualitative detection of SARS-CoV-2 viral particles or secreted protein in anterior nasal swabs or saliva samples. The ease and functionality of DART is similar to a pregnancy test with a "control" line indicating that the test is working, and a second "test" line showing the presence of SARS-CoV-2 viral particles in the sample collected.
"We believe the key to controlling the novel Coronavirus pandemic, both locally and worldwide, hinges upon affordable, reliable and widespread testing. And large-scale testing utilizing specialized PCR equipment and highly-trained personnel simply isn't sustainable," said LabCentral and BioLabs Founder Johannes Fruehauf. "Our goal with the CCRCT is to eliminate unacceptable wait times for both testing and results seen with PCR testing, and achieve test results in real-time, at home, at school or at a business venue, all at a very low price point. Once we are able to provide frequent testing to large clusters of the population, we can detect and isolate new positive cases before the virus spreads and allow a return to as close to normal operations as possible."
The CCRCT kicked off with a three-month trial – which began in early September 2020 – based on volunteer participation from within the LabCentral and BioLabs communities of more than 300 resident scientists and entrepreneurs. Volunteers receive training on how to self-sample for the DART – and a PCR test as a control – two times per week. Testing originally started on-site at LabCentral, but has now transitioned to completely at-home sampling and DART testing. If a participant receives a negative result, no notification is generated. Volunteers may withdraw from the trial at any time, and the final results will be made available publicly.
"Slowing the spread of COVID-19 and getting back to normal requires a science-based, multi-pronged approach including new vaccines, therapies, but above all, more widespread testing – especially of asymptomatic populations," said Irene Bosch, co-founder and CTO of E25Bio. "DART is designed to bring asymptomatic screening to the masses using a simple at-home test that is fast, accurate and affordable and gives people the confidence to "know" they are virus-free as they head back to work, school or other public places."
All costs associated with the implementation and maintenance of the COVID-19 testing are covered by the CCRCT. No costs will be incurred by participants nor their healthcare providers or insurance. Participants will not receive compensation for possible scientific discoveries made using information contributed or biospecimens donated to this project.
In addition to the contributions by its founding members LabCentral, BioLabs and E25Bio, operations of the CCRCT are generously supported by Scismic Inc., which enabled quick and effortless recruitment of scientific staff, Integra Biosciences, which provided robotics and liquid handling equipment, and BioIT, which is developing a customized data management system for the CCRCT. Additional donations to the CCRCT were made by QIAGEN and HiMedia.
LabCentral is working to obtain Clinical Laboratory Improvement Amendments (CLIA) certification. This certification allows the Consortium to accept human samples for diagnostic testing and will become a resource for other companies developing novel rapid tests within the CCRCT framework.
A private, non-profit institution, LabCentral was founded in 2013 as a launchpad for high-potential life-sciences and biotech startups. Operating a total of 100,000 square-feet in the heart of Kendall Square in Cambridge, Mass., LabCentral offers fully permitted laboratory and office space for as many as 70 startups comprising approximately 500 scientists and entrepreneurs. More information is available at www.labcentral.org.
BioLabs is a membership-based network of shared lab facilities located in the nation's key biotech innovation clusters, designed exclusively for high-potential, early-stage life science companies. It offers co-working environments that pair premium, fully equipped and supported lab and space with unparalleled access to capital and industry partners. Visit www.biolabs.io to learn more, contact the team, and apply for space.
E25Bio's mission is to predict outbreaks around the world and deliver unique and affordable testing solutions that help to control them and prevent pandemics. Its point-of-care, rapid detection tests for "fever viruses," including SARS-CoV-2, Zika, Dengue and Chikungunya, can provide results as little as five to 15 minutes. Visit www.e25bio.com/ for more information.