Home testing company Everlywell said today that it will launch a home test kit with telehealth diagnosis for COVID-19 on Monday.
The Austin, Texas-based company said it will release 30,000 tests immediately and is working with multiple labs to have testing and diagnosis capacity for a quarter of a million people weekly.
Consumers who have COVID-19 symptoms can order the test online and send completed test kits overnight to a CLIA-certified laboratory. Secure digital results will be available online within 48 hours of the lab receiving the sample, and free telehealth consultations with an independent, board-certified physician will be available for those with positive results, according to Everlywell. Cooperating labs are complying with the FDA’s Emergency Use Authorization for COVID-19 testing, the company added.
The test will be available from the company for $135 at no profit to Everlywell, and will be covered by participating HSA and FSA providers. Everlywell said it has asked government officials and public health departments if the test can be made available for free.
Also offering an at-home test kit are testing provider Nurx and its lab partner, Molecular Testing Labs (Vancouver, Wash.), who said they will launch home testing for the virus and telehealth consultations within the week for people who have been exposed to the coronavirus or who are exhibiting symptoms. Nurx healthcare practitioners will screen patients for testing and have the lab ship tests overnight to those who need them. If the test comes back positive, the Nurx provider will advise on next steps, according to the San Francisco-based company.
“For those who we believe are at high-risk, we will be recommending in-person care. Our ability to provide testing will be responsive and dynamic to leading clinical public health guidelines,” Nurx said on its website.
Other companies announced they intend to boost to the supply of in-person COVID-19 tests in the U.S. China-based precision medicine company 3DMed is seeking FDA approval of tests for COVID-19 and COVID-19/influenza A and B, and a countertop PCR machine, which have all received the CE Mark.
3DMed has signed an agreement for Rehovot, Israel-based Todos Medical to distribute the tests in the U.S. and Israel, with U.S. testing to take place in Provista Diagnostics’ lab in Alpharetta, Ga., according to Todos. 3D BioMed has shipped materials to the Provista lab to support the validation being conducted over the coming weeks, the Israeli company added.
“The main differentiation in the 3DMed offering versus other nucleic acid PCR-based testing is the influenza A and B tests combined with coronavirus testing,” said Todos chief medical advisor Jorge Leon in a news release. “This is a clinically meaningful combination because of the extended flu season in the United States that will create additional doubt among healthcare providers regarding the cause of symptoms for patients. The fact that this will be available in one testing paradigm seems to be novel in the United States.”
3DMed learned a great deal during the coronavirus outbreak in Wuhan, China, and wants to share its experiences with the rest of the world, according to company president & CEO Simon Shung.
“Fully automated viral RNA extraction systems and precise nucleic acid detection kits played critical roles in rapidly diagnosing coronavirus disease (in) 2019 with a large scale in Wuhan, China,” Shung said. “Meanwhile, to distinguish between early symptoms of the flu and coronavirus would become very important since people may feel similar to those suffering from their symptoms. We hope to help the U.S. and other countries stop the coronavirus spreading through the collaboration with Todos by doing more precise nucleic acid tests with our products, which were validated by tons of cases in the past few months.”
Separately, CPT Medical, a surgical pack and kit manufacturing firm based in Greenville, S.C., announced it has 54,000 COVID-19 test kits in production for shipment to hospitals, nursing homes, and physician’s offices by the end of next week. The company said it is scheduled to release 95,000 test kits for patient testing in approximately 3 weeks.
CPT said it is also developing an at-home test for physicians to order for their patients to keep virus transmission rates down.
Also, molecular diagnostic company Mesa Biotech said it has won a $561,000 contract from the U.S. Department of Health and Human Services (HHS) to develop a point-of-care COVID-19 test that can provide results in 30 minutes. The Accula SARS-CoV-2 test will be developed on the company’s commercially available platform for Accula Flu A/Flu B and RSV Test, which are both 510(k)-cleared and CLIA-waived.
“As the coronavirus situation escalates and the demand for testing far exceeds capacity, we are encouraged by the support of HHS in the development of our Accula SARS-CoV-2 Test,” said Mesa Biotech CEO Hong Cai. “Our test, which was developed to enable rapid responses to global pandemics, will significantly compress the sample-to-result timeframe with a laboratory-quality test at the point-of-care. This accelerated response will enable health care providers to rapidly screen, isolate, treat or dismiss potential carriers of the virus.”
