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Fierce Medtech’s Top 10 stories of 2020: COVID testing’s ups and downs

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In a typical year, I’d compile our annual roundup of top stories while searching for photos of gold confetti and festive ribbons—champagne, maybe, or some fireworks—while the tune of “Auld Lang Syne” runs through my head, hoping to evoke an air of happy celebration and offer, in our small way, a salute to the accomplishments of the medtech industry during our last trip around the sun.

This year? Not so much.

But despite everything 2020 and COVID-19 brought us and took away—with immeasurable losses of life and ways of living—accomplishments abound. This is no time at all for old acquaintances to be forgot, and never bringing them to mind would only compound tragedy.

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Our most-read stories of the year all tap into a single idea. It’s one that became a constant thought for nearly everyone you might meet starting about nine and a half months ago: How can we learn as much as possible about this pandemic threat?

It’s too small to see. That cough? Well, it may be just a cough, and some people don’t cough at all. How can we know the difference? More precisely, what is being done so we can know?

The story of the coronavirus and our biomedical response has evolved throughout the year, with medtech forming the tip of the spear. (But don’t forget to check out Fierce Biotech and Fierce Pharma’s Top 10 lists, tracking the development of treatments and vaccines.)

The industry encompasses some of the first organizations to sequence the complete SARS-CoV-2 genome and provide computer models of protein targets to researchers in record time. It boasts the designers of new, mass-producible ventilators and manufacturers of personal protective equipment working to meet the emergency need. 

It also includes the makers of diagnostic tests. Using a variety of technologies, these products have not only told us who has been infected and who has not but have also helped inform public health workers how far the disease has spread and how a patient’s immune system may respond as it fights off the pathogen.

But how can we be sure the tests work? In the earliest weeks of the pandemic, the FDA allowed antibody blood tests to be sold in the U.S. without federal review or an official authorization, instead placing priority on assessing the high-throughput molecular laboratory tests used to screen patients for active COVID-19 infection. Serological blood tests were, as the FDA said, comparatively less sophisticated products with lower risks, and were used mainly to track the progression of the virus through a population.

Maybe so, but the policy led to confusion and allowed inaccurate tests—and even some outright fakes—to flood the market. This regulatory flexibility was eventually rolled back, and the FDA joined forces with the National Institutes of Health and the Centers for Disease Control and Prevention to independently validate antibody tests. Our top story of the year covered their first set of findings, establishing 12 tests’ ability to avoid false results. This work would, in part, lead to dozens of diagnostics being taken off the market.

Second place went to the FDA’s first official authorization of a COVID-19 antibody test, developed by Cellex and designed to provide an individual reading within 15 to 20 minutes. Similar to a combination of a blood glucose test and a home pregnancy test, the diagnostic uses blood drawn from a vein and dropped into a device containing a small strip.

The same week, our third most-read story tracked BD’s initial plans to offer an antibody blood test using only a finger stick. At the time—both these stories came out in early April—we didn’t know how long antibodies would last in the blood, nor did we understand what level or exactly which types are needed for a person to consider themselves immune. Those questions persist today.

No. 4 encapsulates one aspect of digital health’s response to the pandemic: the use of digital biomarkers to track the disease, implemented via an early warning system made up of wearable devices. This August, Fitbit posted early findings from a 100,000-participant study showing how its fitness trackers could pick up subtle signs of an oncoming coronavirus infection—even before a person reported feeling symptoms. 

Our fifth story takes us back to COVID-19 antibody testing, with Roche CEO Severin Schwan, Ph.D., describing the early worldwide use of the diagnostic as “a disaster,” rife with inaccurate and inferior products. “Every kind of amateur could produce an antibody test,” Schwan said. “The two of us could do it overnight in the garage.” Roche’s own coronavirus tests would later prove to be a key moneymaker, helping make up the difference in revenue lost from people forgoing more routine health checks and a pandemic-related decline in cancer diagnoses.

Another common story of the pandemic has been companies pivoting their products toward COVID-19 to aid in the effort. The Gates Foundation is no stranger to fighting infectious and transferable diseases around the globe, but early March saw the organization focusing on its hometown of Seattle, which at the time was seeing the worst outbreak in the U.S. The organization helped redirect at-home testing kits from its influenza study to the University of Washington to track the spread.

No. 7 detailed a controversial decision by the FDA to allow CPAP machines to be used as emergency ventilators, as the coronavirus first began to strain hospital capacity in March. However, according to the American Society of Anesthesiologists, these devices can disperse unfiltered droplets into the air, potentially increasing the spread of infection.

A few days later, the FDA would authorize its first commercial coronavirus test, with Roche receiving an emergency green light within 24 hours of submitting its application. Since then, the agency has granted at least 200 molecular test authorizations, as well as 11 for antigen tests and more than 60 for antibody diagnostics—while the U.S. case count has grown from 2,200 that day in March to more than 18 million, and deaths have risen from 51 to 320,000.

Coming in ninth are Quest Diagnostics and LabCorp’s launches of their respective nationwide testing efforts in late April through pharmacies and online portals. And finally, a sobering report the same month from the University of Oxford, saying most of the first two dozen commercially available antibody tests they analyzed were just not accurate enough for any type of widespread use.

But while COVID-19 has upended the world, it hasn’t stopped it turning. Other maladies still require attention and care, and our (nearly) coronavirus-free honorable mentions—as well as Fierce Medtech’s latest class of Fierce 15—show that work in these areas is still making great strides.

They include the FDA’s clearance of the world’s first portable MRI system, developed by Hyperfine Research and designed to be wheeled to the bedside for scanning a patient’s head and brain. Elsewhere, Medtronic’s renal denervation system returned after years of setbacks with new clinical data, showing the ablation procedure could finally help lower stubbornly high blood pressure.

Another story outlined one chapter in Thermo Fisher’s ultimately doomed bid to buy out COVID-19 diagnostic supplier Qiagen. Following months of rumors, Thermo Fisher sweetened its offer with an extra billion dollars, but the pandemic’s demand for testing convinced Qiagen shareholders to go it alone.

Meanwhile, Bayer agreed to pay $1.6 billion to settle 90% of 39,000 injury claims related to its Essure birth control implant. The company had halted sales of the device in 2018 after declining sales and additional restrictions from the FDA.

And, in a more recent entry, late November saw Butterfly Network outline its plans to go public and circumvent the traditional IPO process through a $1.5 billion buyout deal. The hand-held ultrasound developer agreed to be picked up by a special purpose acquisition company, or SPAC, sponsored by the hedge fund Glenview Capital Management—a financial move you may expect to see more of in biopharma and healthcare in the years ahead.

The medtech industry has always had a surplus of interesting stories to tell, even in a year of headlines dominated by a single subject. It has shown resilience and creativity, helping caregivers treat their patients under the most trying of circumstances—while facing the obstacles posed by COVID-19 themselves.  

Fierce Medtech will be taking a short publication break for the holidays, but check in for any breaking news. We will return to your inboxes Jan. 4 to cover the long road ahead. – Conor Hale

The post Fierce Medtech’s Top 10 stories of 2020: COVID testing’s ups and downs appeared first on Tekrati.

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