diagnostic testing

Two individuals shaking hands in front of a window while six other people watch
By  Jessica Hagen 01:13 pm January 2, 2024
Diagnostics company LumiraDx announced it signed an agreement to sell its point-of-care technology to pharma giant Roche for $295 million, with an additional payment of $55 million to fund the platform until the acquisition closes.  LumiraDx developed a diagnostic testing system that uses a small, portable instrument and microfluidic test strips to perform multiple lab-quality tests via a single...
By  Emily Olsen 03:08 pm August 30, 2021
PreciseMDX has announced a new digital health platform that aims to simplify diagnostic testing for patients, providers and labs. The company said the system allows for easier scheduling, coordination for on-site or at-home tests and results reporting. The platform automates data entry, which is particularly valuable when facing a large volume of tests, like many labs faced during the pandemic,...
User opening up the Cue Health Monitoring System
By  Mallory Hackett 01:45 pm May 14, 2021
Cue Health, a rapid diagnostics startup with a connected testing device platform, has closed a massive $235 million private financing round. Investments were made by new backers Perceptive Advisors, MSD Capital and Koch Strategic Platforms, as well as by existing investors including Johnson & Johnson Innovation, Decheng Capital, CAVU Ventures, ACME Capital, and others. This latest cash...
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...