The first Covid-19 test authorised by the FDA for use by the patient at home has come not from one of the diagnostics giants. Rather, it has been developed by a small private group which has, over the past five years, secured less than $70m in funding. Lucira Health, formerly known as Diassess, yesterday gained EUA for the Lucira Covid-19 All-In-One kit, a prescription-only test that can be used at home to detect viral RNA on self-collected nasal swabs by people aged 14 and older. The swab is put in a vial that is itself placed in a battery-powered test unit. In 30 minutes or so the results appear on the unit’s light-up display. The assay had positive and negative percent agreement of 94% and 98% respectively, when compared with “one of the most reliable” FDA-authorised molecular tests, according to its instructions for use. Lucira says the test will cost around $50 but roll-out will take time: it will be available to patients in Northern California and the Miami-Fort Lauderdale region of Florida “in the near future”, but US-wide availability is likely to take until early spring 2021.
|Lucira Health's funding|
|Jan 16, 2020||Series B||17.5||Undisclosed|
|Aug 5, 2019||Series B||15.0||DCVC Management; Eclipse Ventures; Seraph Group; Shangbay Capital; Sunstone Management; Y Combinator|
|Jul 16, 2018||Grant||21.9||Barda|
|Oct 9, 2015||Series A||13.1||Eclipse Ventures; Data Collective; Hedgewood; DHVC; StartX|
|Source: EvaluateMedTech, company communications.|