FDA tightens requirements for COVID-19 serology tests; Novartis, Propeller Health's digital inhaler moves toward EU approval and more digital health news briefs

Also: HHS awards $20 million in telehealth access, infrastructure funds; Lumi launches online service.
By Dave Muoio
03:43 pm
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Following numerous reports of underperforming COVID-19 antibody tests, the FDA has raised the bar for these products in a revision to its emergency testing policy.

As of today, commercial manufacturers that notify the agency of their intent to submit a test for Emergency Use Authorization are required to do so within 10 business days from the date of notification. Further, the FDA has recommended specific sensitivity and specificity-performance thresholds for those developing these antibody tests.

In a post announcing these changes, Dr. Anand Shah, deputy commissioner for medical and scientific affairs, and Dr. Jeff Shuren, director of the Center for Devices and Radiological Health, said that the agency stood by its earlier policy that led to greater serology test availability. However, it has also noticed an increase in "unscrupulous actors marketing fraudulent test kits," as well as "a concerning number of commercial serology tests" either being promoted inappropriately or performing poorly during independent evaluations.

"When we become aware of these issues, we have and will continue to take appropriate action against firms unlawfully marketing their tests, for example, by detaining and refusing illegitimate test kits at the border," they wrote. "If particular commercial manufacturers that are currently marketing tests under our March 16 policy fail to submit an EUA within 10 business days, we intend to share this information publicly. We will keep up our work to stop illicit tests from entering the U.S., and we encourage states, hospitals and consumers to be on high alert and to make informed purchasing decisions regarding these tests."

The agency has also introduced two new templates intended to streamline the process of submitting for a COVID-19 antibody testing EUA.


Novartis announced last Friday that Enerzair Breezhaler, an inhaled medication paired with a Propeller Health sensor and custom-built app, has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending approval of the product as a maintenance treatment for certain adult asthma patients. The European Commission considers these recommendations in its final decision, which the pharma company expects in roughly two months.

The Breezhaler device and app encourages patients to adhere to the treatment and administer it correctly, while also collecting data that can be shared with a clinician. Should Novartis' product be approved, it would be the first asthma treatment in the EU that can be prescribed alongside a digital component.

“Today’s news is a key milestone in our journey to reimagine asthma care by bringing innovative medicines and a digital companion to patients with uncontrolled asthma,” Dr. Linda Armstrong, respiratory development unit head at Novartis Pharmaceuticals, said in a statement. “Once-daily [indacaterol acetate, glycopyrronium bromide and mometasone furoate (IND/GLY/MF)] has the potential to improve asthma control for patients whose lives are still impacted by their disease, despite existing inhaled therapies. Additionally, we are pleased to bring an innovative sensor and app companion supplied with IND/GLY/MF to patients to help support enhanced adherence.”


In response to COVID-19, the U.S. Department of Health and Human Services announced last week that it has awarded $20 million in new funds intended to increase telehealth access and infrastructure. Deployed through the Health Resources and Services Administration, these new funds will assist telehealth providers with cross-state licensure to improve access to healthcare during the pandemic.

"This new funding will help expand telehealth infrastructure that is already being used during the pandemic to provide essential care, especially to the most vulnerable, including pregnant women and children with special healthcare needs," HHS Secretary Alex Azar said.


Last Friday came with news that Lumi, an online service that helps parents manage behavioral-care plans for children with or without developmental needs, has launched and is accepting clients.

Lumi's business allows parents to schedule online applied behavior analysis (ABA) services with a board-certified behavior analyst. After completing an initial visit and assessment, the service will provide a personalized treatment plan within one to two weeks, as well as the option to continue virtual sessions.

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