PCB007 Magazine

PCB007-Apr2020

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74 PCB007 MAGAZINE I APRIL 2020 inkjet technologies are being investigated to make LoPCB cost less and more accurate for more applications. In fact, during the month of March 2020, the U.S. Food and Drug Administration (FDA) issued emergency use authorization (EUA) to six firms to allow them to use their SARS-CoV-2 EUA test for the fastest available molecular point-of-care (PoC) test for the detection of novel coronavirus (COVID-19). These six firms are: 1. Roche Holding AG (March 13) [7] : The test uses Roche's fully automated Cobas 6800 and Cobas 8800 systems. With this autho- rization it will have millions of tests avail- able each month for use on the two Cobas systems. 2. Thermo Fisher Scientific (March 14) [8] : The test can be run on and is optimized for use on the Applied Biosystems 7500 Fast Dx Real-Time PCR instrument. 150,000 test kits are available today, and TFS expects to ramp up to 5 million a month by April. 3. Hologic Laboratories (March 16) [9] : Tests run on the automated, high-throughput molecular diagnostic platform, the Panther Fusion, which can provide results in less than three hours and process up to 1,150 coronavirus tests in 24 hours. 4. Quidel (March 17) [10] : Noted that its Lyra product (Lyra SARS-CoV-2 assay for the detection of the coronavirus that causes COVID-19) line offers PCR reagent kits that can be used by laboratories equipped with molecular testing instrumentation, such as the Applied Biosystems 7500 Fast DX platforms from Thermo Fisher Scien- tific. 5. Laboratory Corporation of America (March 23) [11] : Can perform on-site serological and molecular tests for COVID-19, using Cepheid's recently announced GeneXpert System "Xpress SARS-CoV-2 Molecular Test" for up to 20,000 tests per day. 6. Abbott Laboratories (March 27) [12] : The test runs on the m2000 RealTime Molecular System for centralized lab environments combined with ID NOW controller. It can provide positive results in five minutes and negative results in 13 minutes. Abbott is prepared to produce 50,000 test devices per day. Other molecular PoC testing platforms from Agilent Technologies, Alere Toxicology, Acelis Health, and Sony Micronics may not be far be- hind. PCB007 References 1. D. Moschou, "The Challenges of Redesign for Lab-on- PCB," AltiumLive Conference, Munich, Germany, October 2018 2. Agilent 2100 Bioanalyzer Product brochure. 3. D. Moschou, "Commercial PCB Technology Is Advancing Point-Of-Care Medical Diagnostics," Electronics World, June 2019. 4. J. Pawan, J. Rainbow, A. Reqoutz, P. Estrela, & D. Mos- chou, "A PNA-based Lab-on-PCB diagnostic platform for rapid and high sensitivity DNA quantification," Centre for Biosen- sors, Bioelectronics, and Biodevices, Department of Electron- ics and Electrical Engineering, University of Bath, U.K. 5. D. Moschou & A. Tserepi, "The Lab-on-PCB approach: Tackling the uTAS commercial upscaling bottleneck," Jour- nal of the Royal Society of Chemistry, Vol. 17, 2017, pp. 1,388– 1,405. 6. N. Vasilakis, K.I. Papadimitriou, D. Evans, H. Morgan, & T. Prodromakis, "A Commercially Available Lab-on-PCB Technol- ogy for Affordable, Electronic-Based Point-of-Care Diagnos- tics," Nanofabrication Centre, School of Electronics and Com- puter Science, University of Southampton, U.K. 7. Roche, "Roche's cobas SARS-CoV-2 Test to detect novel coronavirus receives FDA Emergency Use Authorization and is available in markets accepting the CE mark," March 13, 2020. 8. 360DX, "Thermo Fisher Coronavirus Test Gets FDA Emer- gency Use Authorization," March 14, 2020. 9. 360X, "FDA Grants Emergency Use Authorization for Coronavirus Assays From Hologic, LabCorp," March 16, 2020. 10. Genomeweb, "Quidel Nabs FDA Emergency Use Authori- zation for Coronavirus Assay," March 17, 2020. 11. Laboratory Corporation of America, "LabCorp Develop- ing Options to Prioritize COVID-19 Testing for Inpatient Popula- tion in Support of Guidance from the White House Coronavirus Task Force," March 23, 2020. 12. Abbott, "Detect COVID-19 in as Little as 5 Minutes," March 27, 2020.

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