March 5, 2021
The FDA has issued its first emergency use authorization for a COVID-19 molecular diagnostic test that does not require a prescription and can be used at home.
Developed by Cue Health, the Cue COVID-19 Test for Home and Over the Counter Use was first authorized for point-of-care use last June.
It uses a nasal swab sample collected from the lower nose to detect the presence of SARS-CoV-2 RNA, and...
March 3, 2021
Reperio Health, the maker of an app-connected home wellness assessment kit marketed to employers, has raised $6 million is seed funding. The round was co-led by Caduceus Capital Partners and Rogue Venture Partners, and saw participation from Liquid 2 Ventures and G Ventures.
WHAT IT DOES
To enable at-home screenings, the Portland, Oregon-based company ships a kit directly to employees or...
December 3, 2020
Everlywell, a digital consumer platform for ordering and viewing lab tests from home, has closed an oversubscribed $175 million Series D funding round, the Austin, Texas-based company announced this morning.
The raise brought in a slew of new investors hailing from BlackRock, the Chernin Group, Foresite Capital, Greenspring Associates, Lux Capital, Morningside Ventures and Portfolia. It also saw...
November 18, 2020
Yesterday afternoon, the U.S. FDA issued an Emergency Use Authorization (EUA) to a COVID-19 molecular diagnostic test that provides individuals with a result within 30 minutes, in the comfort of their home.
As opposed to currently available at-home testing products, which have patients self-collect a nasal swab sample and ship it for processing in a lab, the Lucira COVID-19 All-in-One Test Kit...
September 9, 2020
Just two months after closing its Series B funding, Truepill, a digital pharmacy that focuses on APIs, telehealth practitioners and pharmacy fulfillment services, announced a new $75 million Series C funding round.
The funding, which will help kick off the company's at-home lab testing efforts, was led by Oak HC/FT with participation from Optum Ventures, TI Platform Management, Sound Ventures...
June 26, 2020
Israel-based smartphone urinalysis and wound-care startup Healthy.io is purchasing fellow home-diagnostics company Inui Health in a roughly $9 million cash deal, CNBC reports.
The agreement also involves milestones that Inui Health will need to meet, and sees CEO Dr. Jaime Tenedorio take on a new role within Healthy.io's team.
MobiHealthNews has reached out to both companies for confirmation of...
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...
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...
April 21, 2020
Thanks to an updated emergency use authorization (EUA) from the FDA, LabCorp's COVID-19 RT-PCR test is now the first diagnostic test for COVID-19 that permits at-home sample collection.
Now, patients may use Q-tip-style nasal cotton swabs and saline included in LabCorp's designated self-collection kit – which the company is branding as the "Pixel by LabCorp COVID-19 Test." These samples are...
April 1, 2020
Testing for COVID-19 has been somewhat of a roller coaster in the last few weeks. With each day, the FDA pushes forward in its efforts to expedite the review and rollout of sorely need COVID-19 diagnostic testing. It has enabled the Emergency Use Act, which relaxes standards during a time of crisis.
On March 30 the agency revealed that, since January, it has worked with more than 230 test...