OraSure Technologies has just completed an expansion that will allow it to manufacture almost 2 million in-home COVID-19 self-tests per week, while also creating or retaining more than 400 jobs in the Lehigh Valley.

OraSure, a home-grown Bethlehem-based developer and manufacturer of point-of-care diagnostic tests and specimen collection devices, celebrated the addition of 139,000 square feet of manufacturing space to its Bethlehem Township facility.

The expansion will allow for increased production of InteliSwab, OraSure’s COVID-19 rapid test to identify the SAR-CoV-2 antigen. The new expansion will allow the company to manufacture almost as many tests in a single week as it used to produce in an entire year.

“It’s been an all-in effort from everyone serving to address the pandemic, and our endeavor to launch this test required marshaling all of our resources, company-wide and beyond,” said Carrie Eglinton Manner, President & CEO of OraSure Technologies. “Success also required overcoming numerous challenges. Today, I am proud to share the results here.”

About 150 people attended a ribbon-cutting ceremony at the 2685 Opus Way facility on Oct. 3. OraSure previously announced the expansion was expected to create 177 new full-time jobs and retain 233 more existing jobs.

InteliSwab is a simple-to-use home test in which the user inserts the applicator into his or her nostril, takes a sample, dips it into solution, and waits for the test results. But bringing it to market was not an easy task, according to Lisa Nibauer, OraSure’s President of Diagnostics.

Development of InteliSwab required determining the right combination of antibodies to COVID-19 for use in the antigen test, followed by clinical testing, obtaining three FDA Emergency Use Authorizations, and then developing the marketing and selling plans to compete with an ever-changing landscape of new rapid tests.

“We had to develop a new rapid test for a brand-new disease that was overtaking the world and shutting down society,” Nibauer said. “There were hurdles, which at times felt unsurmountable, yet teams rose to the challenge, and persevered.”

Even after the test was developed, OraSure faced challenges in manufacturing it, she said. Before the expansion, the company saw hundreds of millions of dollars of orders come in due to the Delta and Omicron variant surges that simply couldn’t be filled, as the company worked to ramp capacity.

“For those in operations, including the folks in manufacturing, supply chain, and engineering, this may have been the biggest challenge of their careers,” Nibauer said. “It was a Herculean effort. Teams rose to the challenge and uncovered numerous process improvements to increase output by more than 500%. Bit by bit, they attacked inefficiencies, eliminated bottlenecks, and overcame challenges.”

OraSure has always been on the front lines when it comes to public health crises. It was first to develop an in-home oral HIV test for over-the-counter use, and when the Ebola virus struck West Africa seven years ago, the federal government sought OraSure’s help in designing a rapid test to screen patients.

As many as 110 million tests will be made in the facility each year, said Zachary Wert. OraSure’s Senior Vice President Global Operations. Products will be made in six six formulation suites, with two lines coming online in December, and four more lines opening next year. The expansion project was funded by $109 million in federal funds from the U.S. Department of Defense.

The Lehigh Valley is a Top 50 manufacturing market nationwide, and manufacturing jobs have grown about 11 times greater than the annual growth rate across the whole county over the last five years. The Lehigh Valley has more than 750 manufacturers employing about 35,000 people, and manufacturing is the second largest economic sector of the regional economy, contributing $7.9 billion to the region’s $42.9 billion gross domestic product.

“Today’s event celebrates American manufacturing taking place here in the Lehigh Valley, the benefit of which goes beyond what is made and produced, because any country that is manufacturing is by definition innovating,” U.S. Sen. Bob Casey said during the ribbon-cutting. “We’re also celebrating job growth, and not just jobs of any kind, but high-skilled jobs done by a highly-trained, highly-skilled workforce.”

Pennsylvania Sen. Lisa Boscola noted that the Lehigh Valley just celebrated a 310,000 square-foot expansion at B. Braun Medical Inc. last week, and is now welcoming additional manufacturing growth in the region by OraSure Technologies.

“Manufacturing is alive and well in the Lehigh Valley,” Boscola said. “… OraSure has a legacy of working to solve difficult diagnostic challenges, and I’m proud that they call Bethlehem home.”