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Cue Health wins FDA de novo authorization for home COVID-19 test

The Cue Reader for the company’s COVID-19 test. [Image courtesy of Cue Health]Cue Health (Nasdaq:HLTH) announced that it received FDA de novo authorization for its Cue COVID-19 molecular test.

San Diego-based Cue Health designed the test for both home and point-of-care use. Its authorization marks the first such nod for a home-use COVID-19 test, the company said. It also represents the first de novo authorization for any home-use respiratory test, according to a news release.

Cue Health originally made its COVID-19 test available to consumers without a prescription in 2021. That availability came under the FDA’s emergency use authorization (EUA), a widely used pathway for COVID-19-related products.

The molecular test delivers results in just 20 minutes to connected mobile smart devices. It demonstrated overall accuracy of 98%, detecting all known COVID-19 variants of concern. The test also integrates into Cue Care, the company’s state-of-t…

Cala Health, Cue Health have layoffs in California

[Image courtesy of Nastuh Abootalebi on Unsplash]Cala Health and Cue Health (Nasdaq:HLTH) both recently filed with the state of California to confirm reductions in their workforces.

The two companies are the latest to join the long list of medtech companies cutting employees amid a challenging time for the industry. To date, MassDevice has reported on more than 18,000 medtech employees who have been let go.

According to California WARN notices, Cala, a neuromodulation technology developer, laid off 107 employees.

The filing lists the type of reduction as a permanent layoff pertaining to Cala’s San Mateo, California location. California received the notice of the workforce reduction on May 17. According to the filing, the layoffs go into effect on June 30.

Cala develops transcutaneous afferent patterned stimulation (TAPS) therapy for treating tremor. The company delivers TAPS therapy with its Cala Trio device. Last month, Cala introduced its nex…

Cue Health submits RSV molecular test to FDA for de novo clearance

Cue Health (Nasdaq:HLTH) announced today that it made a de novo submission to the FDA for clearance of its RSV molecular test.

The submission aims to garner full clearance of the test for at-home and point-of-care use. According to Cue Health, no respiratory syncytial virus (RSV) tests exist on the market for home use. Pending FDA clearance, the test could provide a first at-home molecular RSV test for use on people of all ages.

Cue’s RSV molecular test cartridge uses a lower nasal swab. It features compatibility with the Cue Reader, which communicates results digitally via Bluetooth. It can communicate these results in approximately 25 minutes.

“Both young children and older adults are at high risk for severe RSV infection, which includes symptoms similar to the flu, COVID-19, and the common cold, but has a distinct plan for managing care,” said Dr. David Tsay, chief medical officer for Cue Health. “This makes early detection of the virus even mor…

Cue Health, Major League Baseball partner on COVID-19 testing

Cue Health (Nasdaq:HLTH) and Major League Baseball (MLB) announced today that will expand on league-wide COVID-19 testing.

Under a national partnership, Cue Health — MLB’s trusted at-home testing solution — will provide MLB clubs as well as the league office with its integrated care platform that includes the portable and reusable Cue Health monitoring system (reader) and the COVID-19 self-test.

Cue Health’s molecular COVID-19 test uses nucleic acid amplification technology (NAAT) to provide lab-quality results directly to connected mobile devices in 20 minutes, according to a news release. The company said its platform can detect all known COVID-19 variants of concern on users age 2 years old and up with or without symptoms.

“Major League Baseball, like other world-class organizations, continues to turn to Cue for testing when the stakes are high and when accuracy, speed, and reliability cannot be compromised,” Cue Health co-foun…

Cue Health launches direct-to-consumer virtual health platform

The Cue Health molecular COVID test includes a nasal swab, test cartridge and cartridge reader for home use. (Image from Cue Health)

Cue Health (NSDQ:HLTH) announced today that it will launch its direct-to-consumer virtual health program on Nov. 15, 2021.

San Diego-based Cue Health’s virtual health platform includes what it says is a first-of-its kind molecular COVID-19 test through its new eCommerce site and in-app shop. The company said in a news release that it makes the COVID-19 test that has been used by organizations including Google, Mayo Clinic, the NBA, the MLB and others, available to individual consumers.

“We’ve had a lot of interest from the general public eager to purchase our COVID-19 tests: from parents who need to keep their kids healthy in school to international business travelers to families who want to gather safely this holiday season,” Cue Health Co-Founder & Chief Product Officer Clint Sever said in the release. “We’…

MedTech 100 roundup: Turnaround for the industry?

A turgid month for the medtech industry might be drifting into the past after the past week indicated a slight turnaround as summer nears.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the week at 107.74 points, marking a 1.4% rise from the 106.22-point mark set one week prior.

Having endured its largest slide of 2021 in recent weeks, the index is already demonstrating signs of a rebound after April brought the industry’s all-time best performance.

Despite the setbacks that have plagued the industry over the past month or so, medtech’s performance continues to reflect a rebound from the struggles brought on by the COVID-19 pandemic. Overall, it has registered a 16.7% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus a 73.4% increase from the mid-pandemic low of 62.13 (March 23, 2020).

The overall markets were on the opposite end of the spectrum over the p…

Cue Health raises $235M to support its over-the-counter, home-use diagnostics

Healthcare technology company Cue Health announced that it closed a private financing round worth $235 million.

Existing investors Johnson & Johnson Innovation — JJDC, Decheng Capital, CAVU Ventures, ACME Capital and more contributed to the financing, as did new investors Perceptive Advisors, MSD Capital and Koch Strategic Platforms, according to a news release. Morgan Stanley served as exclusive financial advisor to Cue for this transaction.

San Diego-based Cue Health said it earmarked the capital raised to accelerate its growth as it develops digital health technologies, starting with diagnostics. In October 2020, the company received a $481 million government contract for its point-of-care COVID-19 diagnostic.

Cue develops the Cue Health Monitoring System, which it designed to deliver a wide range of tests through one system. Its current uses include COVID-19 testing in enterprises, schools, nursing homes, hospitals and more.

The company ad…

5 at-home COVID-19 diagnostic tests you should know

The wait for a completely at-home COVID-19 test ended in November when the FDA authorized the first ones that enabled people to obtain samples and results at home.

The agency has authorized five at-home COVID-19 testing kits for emergency use since the beginning of the pandemic. The kits are made to take a sample using self-administered nasal swabs. The results are delivered in less than an hour using technology similar to pregnancy tests, revealing positive or negative results.

However, there is a risk of false positives and negatives using rapid antigen tests at home, the FDA has warned. The agency said in a Dec. 15 press release that patients without symptoms who present a positive test should be treated as “presumptively positive” until it can be confirmed by another test. Patients who test negative and experience COVID-like symptoms are advised to follow up with their healthcare providers as a negative result does not rule out a SARS-CoV-2 infection.

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5 at-home COVID-19 diagnostic tests you should know

[Image from unsplash.com]

A year into the COVID-19 pandemic, the wait for a completely at-home COVID-19 test ended when the FDA authorized the first ones in November to enable people to obtain samples and results at home.

The FDA has authorized five at-home COVID-19 testing kits for emergency use since the beginning of the pandemic. The kits are made to take a sample using self-administered nasal swabs. The results are delivered in less than an hour using technology similar to pregnancy tests, revealing positive or negative results.

However, there is a risk of false positives and negatives using rapid antigen tests at home, the FDA has warned. The agency said in a Dec. 15 press release that patients without symptoms who present a positive test should be treated as “presumptively positive” until it can be confirmed by another test. Patients who test negative and experience COVID-like symptoms …

First OTC molecular test for COVID-19 gains FDA nod

The Cue Health molecular COVID test includes a nasal swab, test cartridge and cartridge reader for home use. (Image from Cue Health)

The FDA today issued its first emergency use authorization for a molecular COVID-19 diagnostic test for at-home use without a prescription.

The Cue Health COVID-19 Test for Home and Over The Counter (OTC) use is a molecular nucleic acid amplification test designed to detect genetic material from the SARS-CoV-2 virus in the nostrils.

The authorized test includes a single-use Cue COVID-19 test cartridge, a single-use nasal swab and the Cue cartridge reader (used by the Cue Health monitoring system, provided separately). The reusable, battery-operated cartridge reader runs the Cue test cartridge and communicates results directly to the customer’s Cue Health smartphone app in about 20 minutes.

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