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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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