diagnostic testing

Three screens of the Ellume COVID-19 Home Test App
By  Dave Muoio 03:13 pm December 15, 2020
The U.S. FDA announced today an Emergency Use Authorization for the first over-the-counter COVID-19 diagnostic test for home use. Developed by Australian digital diagnostics company Ellume Health, the single-use kit is accompanied by a Bluetooth-connected app that guides users through the testing process and automatically reports its results for disease monitoring. The test returns its results in...
By  Dave Muoio 11:51 am June 10, 2020
Cue Health, a rapid diagnostics startup now working on a connected testing device, has closed $100 million in a Series C round announced this morning. Decheng Capital, Foresite Capital, Madrone Capital Partners, Johnson & Johnson Innovation, ACME Capital and other unnamed investment firms all participated in the raise. WHAT THEY DO The San Diego-based company's leading product is the Cue...
By  Dave Muoio 03:36 pm May 6, 2020
New York City-based home-lab-test startup LetsGetChecked said this morning that it has wrapped up an oversubscribed $71 million Series C round co-led by Illumina Ventures and HLM Venture Partners. The raise also included new backers Deerfield, CommonFund Capital and Angeles Investments, while investors Transformation Capital, Optum Ventures and Qiming Venture Partners USA returned to further fuel...
By  Dave Muoio 04:32 pm March 23, 2020
Last week saw a number of diagnostic testing startups, telehealth providers and others announce new services that would deliver at-home COVID-19 testing-kits to consumers. But the majority of these of offerings have since been rescinded or hang in doubt thanks to new warnings and regulatory clarifications issued this weekend by the FDA. On Friday evening, the agency released an alert to consumers...
By  Dave Muoio 02:43 pm March 20, 2020
Editor's note: Since the publication of this story, the FDA has released an alert warning that it "has not authorized any test that is available to purchase for testing yourself at home for COVID-19." MobiHealthNews has reached out to Scanwell Health, myLAB Box and others about their at-home services: read the updated story here. Scanwell Health and myLAB Box are the two latest at-home...