The U.S. is investing $481 million in California-based start-up Cue Well being to spice up manufacturing of its coronavirus check that produces leads to about 20 minutes and without having to be processed at a lab, U.S. businesses introduced Tuesday.
Cue, which is backed by Johnson & Johnson amongst different buyers, will enhance manufacturing from a number of thousand check kits per day now to 100,000 per day by March, in line with the Division of Well being and Human Providers. It added that the U.S. will purchase 6 million checks and 30,000 lab devices used to course of the checks.
Cue Well being CEO Ayub Khattak informed CNBC that the corporate will possible be “greater than midway” to that objective by the tip of the yr.
“Cue’s checks present leads to about 20 minutes with the sort of accuracy offered by lab checks that may take a number of days, including to our dramatically increasing provide of speedy checks that may assist protected reopening,” Alex Azar, secretary of HHS, stated in a press release.
Cue is a molecular check and it makes use of an in-house nasal swab, known as the Cue Pattern Wand, collected from the decrease a part of the nostril, HHS stated. That is totally different from another speedy molecular checks that use nasopharyngeal swabs inserted deep into the nostril.
Take a look at outcomes might be delivered instantly by way of the Cue Well being cell app, HHS stated. Khattak added that the digital check outcomes will make it simpler to share checks with correct well being officers and doubtlessly conduct contact tracing to assist scale back the unfold of the virus.
“At this time’s announcement of hundreds of thousands of further speedy checks additional demonstrates that the Administration is sparing no effort or expense to save lots of lives and assist our nation safely open, re-open, and keep open,” White Home spokesman Michael Bars stated.
Khattak stated HHS made the award to Cue Well being based mostly on preliminary knowledge from an impartial examine of the accuracy of the check carried out by the Mayo Clinic. The examine has not but been printed.
“The Cue testing system is extremely delicate and particular, and practically equal to the perfect giant referral laboratory techniques,” Adm. Brett Giroir, assistant secretary of well being who leads the federal government’s testing effort, stated in a press release. “This funding will permit Cue Well being, Inc. to develop its footprint and considerably scale up manufacturing, and by doing so allow this know-how to be deployed all through our testing ecosystem to profit all Individuals.”
The company announced on June 12 that it obtained an emergency use authorization for the check from the Meals and Drug Administration. The regulatory company approved the check for use “anyplace below the supervision of certified medical personnel,” the corporate stated.
Khattak stated in a telephone interview that the check is already in use by numerous purchasers, together with the Nationwide Basketball Affiliation, which efficiently performed out its season this yr by making a “bubble” in Orlando, Florida. The check is “the official point-of-care check for the NBA,” he stated.
He added that the corporate hopes to finally get the check approved to be used completely at residence.
“Our North star all alongside has been residence use for the platform,” he stated in a telephone interview. “We expect we’re ready to go and get that further regulatory enlargement for residence use. It is definitely what we would love to do.”
Cue Well being developed the check in partnership with the Biomedical Superior Analysis and Improvement Authority, which is a part of HHS. The partnership started in 2018, when BARDA awarded $14 million to Cue to develop a molecular influenza check with the choice to increase the settlement as much as 60 months for a complete of $30 million. Early within the pandemic, BARDA expanded its partnership with Cue to develop a check for the coronavirus.
“I believe that there is a very nice arc to this,” Khattak stated of the partnership. “They acknowledged the potential. They labored on it. That they had an choice in there that anticipated presumably coronavirus. That acquired activated and we acquired the product out into the market.”