Watmind USA’s serology diagnostic products such as its M2 and M5 are the world’s first portable microfluidic chemiluminescence quantitative serology machines that test for COVID-19, including the combination of IgM, IgG, Total Antibody, and Viral Antigen.
Watmind USA’s equipment already has the full approval of the National Medical Products Administration (NMPA), China’s equivalent of the FDA, a full European CE mark and is now under evaluation for emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the disposable test kits, with applications to follow for the M2 and M5 machines. The company’s equipment holds more than 50 patents.
Watmind USA’s equipment was deployed at “ground zero” of the COVID-19 pandemic in China and Europe.
Watmind USA was created in response to unprecedented demand as the pandemic spread from China and Europe to the United States. Now headquartered in Austin, Texas, a majority of its team is running COVID-19 field operations in New York, Florida, Arizona, Mississippi, Missouri and California.
The following timeline summarizes how the current COVID-19 testing technology was developed and verified over six years:
2014: Shenzhen Watmind is established in Shenzhen, China with R&D teams dedicated to creating the world’s first portable microfluidic chemiluminescence testing machines
2015: Prototype equipment enters the R&D phase
2016: The China Food and Drug Administration (CFDA) clears Watmind’s instruments and the first reagent clinical trial begins
2017: The M2 Serology Machine gains CFDA clearance and manufacturing license and the M5 Serology Machine completes its R&D Phase. Also, 12 different reagents complete the R&D phase
2018: Eight micro-fluidic based reagents begin clinal trials as 17 additional reagents complete the R&D phase. Mass production planning gets underway
2019: China Ministry of Commerce Export License granted for both reagents and instruments and authorized for export for COVID19 response in early 2020.
January 2020: Watmind Portable Serology Machines and Disposable Test Kits and Microfluidic Reagent chips developed in collaboration with research institutions such as the Wuhan Institute of Virology and field tested at the origins of the COVID-19 pandemic in China
February 2020: 250 Wuhan COVID-19 patients tested for infection and immunity using Watmind equipment. The results show a high level of sensitivity and specificity. US Authentic Trading and Unihealth identify this company as important to bring to the West given it’s unique technology.
March 2020: Watmind USA is established to locate research and development in the USA with the goal of becoming a premium global healthcare brand under the Watmind USA name. The first goal is to deploy the COVID-19 assets to assist North and South American epidemic responses through emergency response efforts of the FDA.
April 2020: Watmind USA begins the process to import thousands of disposable test kits and serology machines and finalizes partnerships with major research institutions to validate and develop testing protocols.
May 2020: The FDA’s Center for Devices and Radiological Health (CDRH) acknowledges receipt of the of Watmind USA’s EUA application.