With the current surge in COVID-19 cases, laboratories are once again struggling to keep up with testing demand and meet the critical 24-48 hour turnaround time required for effective management and maximum reimbursement. Testing capacity has seen dramatic growth over the last 6 months. Testing labs in the United States are now running more than 1.8M tests per day – over double the average of 700,000 tests per day in July! Yet, it is still not enough to test all those that should be tested to effectively control the latest surge.
So what is holding back needed testing capacity? There are three main issues:
1. Supply chain issues with hardware, reagents, and consumables
2. Shortage of qualified laboratory personal (Full time equivalents or “FTE’s” in business speak)
3. Current platforms were never designed to handle these volumes.
COVID-19 testing has made us rethink everything involved in high-throughput testing. This includes all aspects from sample collection, to automation, to new purchasing structures. And, at Mammoth, we think we have a solution!
Mammoth Bioscience’s high-throughput testing solution
The NIH launched its Rapid Acceleration of Diagnostics (RADx) program on April 29, 2020. This program’s mission is to bring new testing solutions to market and rapidly increase testing capacity. Mammoth secured a contract from RADx in July and we’ve been working on bringing CRISPR into the high-throughput COVID-19 testing arena ever since.
One major benefit of CRISPR in this context is its speed. We’re coupling this speed with automation to deliver a new level of high-throughput testing. We believe our technology may help to ease the three main constraints of supply chain, FTEs, and testing capacity. Furthermore, our programmable CRISPR technology makes the platform an attractive offering for the future development of additional disease targets.
Our solution is called DETECTR BOOST™ SARS-CoV-2. It combines the speed of CRISPR diagnostics with automated liquid handling equipment. This high-throughput platform has been designed to perform approximately 1,500 tests/per 8-hour shift per automatic handler with minimal hands-on time.
This is up to 5 times more tests than other high-throughput platforms. In addition, users of DETECTR BOOST™ SARS-CoV-2 get their first results from 192 samples in under 2 hours. The platform is also compatible with swab and saliva sample types. Other possible benefits from the platform include lower FTE requirements to run the platform, less reagent supply chain risk, and reduction in plastic pipette tip usage on a per test basis.
DETECTR BOOSTTM SARS-CoV-2 molecular test availability
We are preparing to submit an Emergency Use Authorization (EUA) application with the U.S. Food and Drug Administration in the near future. In the meantime, you can follow our progress on Twitter, LinkedIn and at our website www.mammoth.bio/covid or contact us at email@example.com for more information.
This project is supported by the NIH Rapid Acceleration of Diagnostics (RADx) program and has been funded in whole or in part with Federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92020C00011.