Introduction

 

From Sequence to Solution: Our Unprecedented Response

In early December 2019, Hologic scientists, along with the rest of the world, began to hear of a strange new coronavirus spreading in the Wuhan area of China. Speculation began about how far the virus might spread and what Hologic’s response would be. Some R&D scientists began to work on what a potential test might look like and tinker with design questions.

On January 8, 2020, after the genetic sequence of the virus was made available to the scientific community, work began in earnest. First, our computational team ran analytics that pointed to the best regions to target in the virus’s genetic sequence, and the design team followed up to produce optimal probe and primer designs. The decision was made to pursue a test for Panther Fusion®, the upgrade module for Panther that was launched in 2017. Because of software features unique to Panther Fusion, design would be quick, and it was believed that many physicians would request an influenza test to be run alongside a COVID test, and respiratory virus panels were already available for the Panther Fusion system.

“The initial design was rapid—and we had our first prototypes ready after only a week or two of crunching data,” said Maurice Exner, vice president, R&D, assay development and clinical affairs. “The hard work to follow was figuring out if the test would work as planned, as well as how to make it in large quantities.” As the weeks progressed, the work intensified. In February, as Americans were getting early glimpses into the potential scale of the problem, Hologic R&D scientists were starting to take catnaps in conference rooms, setting alarms in order to pull data and keep instruments running round the clock. Formal submission of the Panther Fusion assay to the U.S. FDA occurred just before 2 a.m. on Saturday, March 14.

The FDA was also working round the clock, as by that time New York and New Jersey hospitals were overwhelmed, the World Health Organization had officially declared a pandemic, epidemiologists were publishing models showing the potential scale of U.S. infections, and California was going into lockdown. Hologic’s test received an Emergency Use Authorization from the FDA on March 16—less than 48 hours after submission.

“Our teams were thrilled, of course,” said Exner. “But there wasn’t a lot of downtime to celebrate. We got right to work on a second assay.”

The Panther Fusion test was immediately put to use in clinical laboratories across the country, but had a couple of limitations. First, there were about 200 Panther Fusion modules in use globally at the time, versus almost 2,000 Panther instruments. Second, the manufacturing capacity for these tests was limited compared to other assays Hologic produces. And although 600,000 tests per month was an impressive number, it was already clear many more would be needed.

“We make tens of millions of tests every year for sexually transmitted infections, cervical cancer screening and viral load monitoring. It’s routine for us, so we knew we had to make a test for Panther, and again, make it as rapidly as possible.” —Kevin Thornal, Division President, Diagnostic Solutions

Once again, Hologic R&D, manufacturing and regulatory affairs teams were working at a furious pace, collapsing what is typically a two-year process to two months. The Aptima® SARS-CoV-2 assay was cleared for use in both the U.S. and Europe in May 2020, and by December 31, 2020, Hologic had shipped approximately 68 million tests.

Ingenuity in the Face of Challenges

Hologic—and the diagnostics industry as a whole—met a number of challenges through the early months of the pandemic. First, testing across the country was slowed by a shortage of the swabs needed to collect samples from the nose or throat, as well as the transport media used to stabilize specimens for transit from doctors’ offices to clinical laboratories. In the face of this issue, Hologic’s teams realized that they had a solution near at hand—the kits typically used for collection and transport of specimens for other kinds of testing, such as for sexually transmitted infections. Millions of the Aptima specimen transfer tubes were in stock, and all other diagnostic testing had come to a crawl. Immediately,the team incorporated use of these transfer tubes into the Aptima SARS-CoV-2 assay design and when Emergency Use Authorization was obtained in May, they were part of Hologic’s latest COVID-19 test, alleviating a major roadblock.

But even as testing ramped up, demand also escalated very quickly. In early August 2020, the FDA endorsed the concept of pooling samples to accelerate testing, and based on the excellent sensitivity of our tests. Hologic became the first manufacturer to develop a pooling protocol. This protocol enables laboratory customers to pool up to five samples in one tube, using either an Aptima or Panther Fusion test. A negative result indicates that all five individuals are clear of infection; if the result is positive, the samples are individually tested.

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Hologic production lines themselves have also been multiplying. Construction at our San Diego facility has been ongoing since January, and tens of millions of dollars have been invested in capital equipment to expand production capacity. This investment includes installation of new high-speed filling lines, as well as new, custom machinery to produce more of the highly specialized parts unique to our sample tubes and test kits.

In the spring and summer of 2020, more than 150 new operations employees were hired in San Diego, representing a more than 50% increase in that work force. While these new hires were being recruited and trained, employee volunteers from teams including information services and finance were trained to work on the packaging lines.

In June, full manufacturing of our new COVID-19 tests was initiated at our facility in Manchester, United Kingdom, which is now mainly supplying European markets.

Both manufacturing plants are operating 24 hours a day, seven days a week, cranking out millions of tests to meet the unprecedented need.

“In total, we succeeded in doubling our overall manufacturing capacity for molecular tests in six months, a process that would normally take about 10 years,” said David Tyler, vice president, operations manufacturing.

Panther® Placements

Not only has there been increasing demand for tests, but labs are clamoring for more Panther instruments. During each of the last several years, Hologic placed approximately 220 new Panther systems globally. In the third quarter of 2020 alone, 208 systems were installed.

Increasing the installed base was achieved through several measures. First, Hologic’s manufacturing partner Stratec, headquartered in Germany, was able to significantly expand their production capacity. Second, our service team and engineers within Hologic set out to locate and refurbish out-of-use instruments. A number of these had been used by R&D teams but replaced by newer instruments.

“Basically, we scoured our campus for every Panther instrument we could track down and get into a customer’s hands,” said Ty Scott, vice president, customer experience and field service. “In an average year, we typically refurbish one or two instruments per month. In the summer of 2020, we increased our monthly output to 24-30 refurbished instruments and shipped out nearly a hundred by year end.”

Scott’s teams worked nearly round the clock, taking calls from international customers and working side by side with Hologic engineers to assess and repair instruments.

“We’ve never seen such demand,” said Scott. “It’s really a testament to the performance of the Panther platform.” As of December 2020, approximately 2,400 Panther systems had been installed worldwide, the most extensive network of any high-throughput molecular diagnostics system.

“The number of placements and demand for more instruments speak not only to the urgent need for COVID testing, but also to our long-term leadership in the molecular diagnostics space, and that is based on listening to the customer,” said Matt Friedenberg, vice president, instrumentation engineering. “I have people on my team who have been here for 15 years or more. Some of them worked on the original Tigris® instrument, taking all customer feedback very seriously. The entire team comes in every day thinking about how to improve our instruments and make life easier for the lab technicians running these critical tests.”

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