LetsGetChecked Debuts FDA EUA-Authorized At-Home Coronavirus (COVID-19) Sure-track Test
LetsGetChecked, the leading direct-to-consumer at-home health testing and insights company, announces today the authorization of the new Coronavirus (COVID-19) Sure-track Test for at-home consumer use by the U.S. Food and Drug Administration under an EUA. The new test is authorized to serve at-risk individuals with a proprietary at-home PCR nasal swab test that delivers accurate and definitive results within 24 hours.
Offering an end-to-end model, LetsGetChecked’s new Sure-track Test introduces the most complete FDA EUA-authorized Coronavirus at-home testing solution. The at-home Coronavirus (COVID-19) test incorporates a nasal swab and PCR lab analysis, offering convenient and secure results in 24 hours. Unlike serology tests that detect the presence of antibodies, the at-home COVID-19 test determines the presence or absence of SARS-CoV-2 viral RNA.
LetsGetChecked’s Sure-track Test is the only FDA EUA-authorized at-home Coronavirus (COVID-19) test that owns all aspects of the testing service, including the collection kit manufacturing process, logistics, lab analysis and physician approval, offering a robust system that delivers unmatched safety and scale for customers. The at-home Coronavirus test is accompanied by LetsGetChecked’s connected platform offering 24/7 telehealth services supported by licensed healthcare professionals and timely guidance on containment and care for those who test positive.
“With the FDA EUA authorization, we are thrilled to introduce the Sure-track Test to offer convenient, secure, and highly accurate at-home testing for coronavirus to communities in need in the United States. We’ve spent years building the only true end-to-end service on the market, which allows us to deliver unparalleled service to our customers.” said Peter Foley, LetsGetChecked founder and CEO.
The company's at-home Coronavirus (COVID-19) test is designed with safety in mind at every touchpoint. After a customer self-collects a swab sample, the collection swab is placed in a special transport tube containing a solution that deactivates the virus, ensuring everyone from shipping providers to lab technicians are protected from contamination and infection. Other tests on the market use a saline solution, which heightens risk by transporting an active virus. The solution also protects the integrity of the SARS-CoV-2 RNA, which heightens accuracy.
“The coronavirus crisis has impacted everyone and we are delighted to not only introduce a reliable testing solution, but one that is safe for everyone involved in the supply chain. Our entire system was considered as part of the review process and we are delighted to have worked with the FDA to deliver a truly unique at-home Coronavirus testing service to our customers,” said Gwen Murphy, PhD, MPH, and Director of Epidemiology and Clinical Studies at LetsGetChecked. “At-home testing will play a central role in ensuring a safe workplace and we are helping to develop and inform protocols with that in mind.”
With a current capacity of 300,000 units per week, LetsGetChecked’s own CLIA/CAP/BSL II certified high complexity laboratory based in Monrovia, California, is building toward a capacity of millions per week in order to meet the demand of partners and individuals in all 50 states.
Prior to today’s EUA authorization from the FDA for at-home use, LetsGetChecked has worked with global leaders from today’s top companies and frontline healthcare workers to offer coronavirus tests to more than 100,000 people. Most recently, LetsGetChecked partnered with the Professional Golfers Association on the TaylorMade Driving Relief tournament to administer tests both before and during the event, assuring that players, crew, and on-site teams were safe to play for the first televised professional sports event since shutdown. The company also developed a mobile app with tracking capabilities to monitor all parties’ symptoms and temperatures. This signals LetsGetChecked's pivotal role in providing industries across all verticals a resource to test individuals nationwide and begin re-opening the country.
The Sure-track Test will be made available for purchase starting on May 28, 2020, for $129 per kit on www.LetsGetChecked.com for at-risk individuals who meet the criteria defined by the website’s guided risk questionnaire. Tests are received within 24 hours from purchase, with definitive results delivered within 24 hours (of the sample being received by the lab).
LetsGetChecked is a leading health insights company that allows consumers direct access to a wide range of testing options and clinical services from home. Founded in 2015, the company empowers people to take an active role in their health to live longer, happier lives. By combining health data and diagnostic results, LetsGetChecked provides rich health insights to enable better healthcare decision making. LetsGetChecked tests cover general health, men's health, women's health, and sexual health, and are available nationwide in the U.S., Canada, and Europe. LetsGetChecked has corporate offices located in New York City and Dublin. For more information, visit www.letsgetchecked.com.
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Spirit of Wipro Run Brings Together Thousands of Participants Globally27.9.2020 08:52:00 CEST | Press release
Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today organized the 15th edition of the ‘Spirit of Wipro’ (SOW) Run globally with thousands of participants across 35 countries, running separately, yet together in spirit, at a time of their choosing. The theme for this year’s Run was “United. Unstoppable”, which celebrated camaraderie, resilience and a shared sense of community among several thousands of Wipro employees, their friends and families, alumni, customers, partners and suppliers. The SOW Run is an annual, global tradition at Wipro and has been held every year since its inception. This year too, the Run was organized on schedule despite the pandemic induced constraints. The runners strictly adhered to the local COVID-19 guidelines and safety protocols in various countries while participating in the event. Commenting on the Run, Thierry Delaporte, Chief Executive Officer and Managing
BCG Collaborates with Tencent Marketing Insight to Release 2020 BCG x Tencent Digital Luxury Report25.9.2020 12:21:00 CEST | Press release
Since early 2020 when the COVID-19 pandemic broke out worldwide, the luxury market has been hit hard and is expected to decline 25% to 45% compared to the previous year. The Chinese luxury market, however, which has benefitted from successful domestic control of the pandemic and has taken the lead in recovery against a depressed global market environment, is forecast to grow from 20% to 30% in the whole year of 2020. Thanks to its stunning market performance, China has become the main battleground of each major luxury brand. In was in this environment that Boston Consulting Group (BCG) joined hands with Tencent Marketing Insight (TMI) to release the 2020 BCG x Tencent Digital Luxury Report, drawing on deep insights into post COVID-19 trends in the luxury market and consumers based on BCG and TMI’s quantitative consumer research and industry experience, as well as TMI’s marketing and big data capabilities. Crystal Hao, Managing Director & Partner of BCG said, “The luxury market in China
U.S. MRTP Authorization Pathway Explored in PMI’s Latest Scientific Update25.9.2020 12:15:00 CEST | Press release
Philip Morris International (PMI) (NYSE: PM) has released the 11th edition of its Scientific Update, a regularly issued publication on its research efforts to develop and scientifically assess a range of smoke-free alternatives to cigarettes. The latest edition features an overview of the historic decision made by the U.S. Food and Drug Administration (FDA) to authorize the marketing of the IQOS Tobacco Heating System with reduced exposure information. The Scientific Update explains the various MRTP decisions under U.S. law; the steps, processes, and timeline PMI undertook; and the ongoing post-market surveillance and studies that will monitor the impact of the orders on consumer perceptions, behavior, and health. “The FDA undertook a scientific and regulatory evaluation of IQOS and determined that it is ‘appropriate for the promotion of public health’” said Dr. Gizelle Baker, director of Global Scientific Engagement at PMI. “In this edition of our Scientific Update, we describe how th
Palladio Completes $20 Million Series B Financing25.9.2020 12:09:00 CEST | Press release
Palladio Biosciences, Inc. (Palladio), a privately-held, clinical stage biopharmaceutical company developing medicines for orphan diseases of the kidney, announced today the completion of a $20 million Series B investment. The financing was led by new investor, Samsara BioCapital, with participation from new investor, the Roche Venture Fund and existing investors, Medicxi and Osage University Partners. Proceeds from the financing will fund Palladio’s Phase 3 ALERT Study and advance operations. Srinivas Akkaraju M.D, Ph.D, Managing General Partner of Samsara BioCapital, stated, "We are very excited about our investment in Palladio to support the development of lixivaptan, a drug that has the potential to deliver a meaningful therapeutic advancement in the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). The ALERT Study is an important step in assessing the safety differential of lixivaptan.” “We are very pleased that Samsara and the Roche Venture Fund recognize the opp
Ant Group Launches “Trusple,” an AntChain-Powered Global Trade and Financial Services Platform for SMEs and Financial Institutions25.9.2020 09:54:00 CEST | Press release
Ant Group, a leading provider in the development of open platforms for technology-driven inclusive financial services, and the parent company of China’s largest digital payment platform Alipay, today unveiled Trusple, an international trade and financial service platform powered by AntChain, the company’s blockchain-based technology solutions. Trusple aims to make it easier and less costly for all participants – especially Small-to-Medium Enterprises (SMEs) – to sell their products and services to customers around the world. It also reduces costs for financial institutions so they can better serve SMEs in need. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200925005110/en/ (Photo: Business Wire) Based on the concept of “Trust Made Simple,” Trusple works by generating a smart contract once a buyer and a seller upload a trading order on the platform. As the order is executed, the smart contract is automatically updated with k
Ipsen Appoints Philippe Lopes-Fernandes as Executive Vice President, Chief Business Officer25.9.2020 07:00:00 CEST | Press release
Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200924005822/en/ Philippe Lopes-Fernandes, Executive Vice President, Chief Business Officer, Ipsen (Photo: Business Wire) Ipsen (Euronext: IPN; ADR: IPSEY) today announced the appointment of Philippe Lopes-Fernandes as Executive Vice President, Chief Business Officer, effective 1 October 2020. Based in Cambridge, Massachusetts, USA, he will be responsible for business development and alliance management, reporting directly to David Loew, CEO, Ipsen. Philippe will serve on the Executive Leadership Team. “As Chief Business Officer, Philippe will play a crucial role in our external innovation strategy. The ELT and I are delighted to welcome Philippe to Ipsen and look forward to working closely with him. His extensive and impressive track record in international business development, his outstanding reputation and his ability to work closely with the scientific comm
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom