A long-time innovator in the infectious disease space, Hologic developed some of the first nucleic acid tests to screen the blood supply for HIV and hepatitis C more than three decades ago. The company rapidly developed an assay for influenza subtyping in response to the 2009 H1N1 pandemic, and in 2016 it was granted Emergency Use Authorization (EUA) for an assay to address a rise in cases of the Zika virus, a mosquito-borne illness that can cause serious birth defects. Today, the company continues to build on its robust portfolio of diagnostic solutions including testing for many respiratory viruses, sexually transmitted infections and cervical disease screening.

“I remember when we received the stay-at-home orders and all the feelings of uncertainty but knowing we had to act quickly because diagnostics is where Hologic excels,” said Jimmykim Pham, who was part of a team that worked on developing multiple COVID-19 assays in early 2020. Pham was motivated to pursue a career in medical test development after seeing a loved one go through challenges associated with a hepatitis C diagnosis. “Working in preventive care has always held a very personal meaning to me,” she says.

Navigating through the unknown

The process of developing and clinically validating a new test typically takes years. This timeline would need to be reduced to weeks in light of the growing public emergency. Aside from the R&D-related hurdles of rapidly developing and testing an assay for a novel virus, supply chain issues were worsening due to the impacts of the pandemic.

“We'd run out of supplies needed to conduct testing,” recalls Sarah Meyer, who worked alongside Pham on test development. “The assay team pulled together to maximize use of the materials we did have, and the engineers supported the effort by validating additional vendors so we could keep testing. The ingenuity that came with necessity at that time was unparalleled." 

Mutation of the virus was also expected, prompting the team to think through ways to ensure the test would still provide accurate results as different strains emerged over time.

"For the first COVID-19 assay, there was limited information available about the target genome,” says Meyer. “The team expected mutations over time and worked to identify and design the assay in regions we believed to be stable. For each of our COVID-19 tests, we target two different regions of the SARS-CoV-2 gene, so if a mutation arises in one location, the second location will provide coverage so that we maintain inclusivity.”

In March 2020, only a few months after the virus was identified, Hologic announced an EUA from the FDA for the Panther Fusion SARS-CoV-2 Assay. The company received authorization for its second COVID-19 test, the Aptima^® SARS-CoV-2 Assay, which could be produced in large quantities, that May. The Aptima and Panther Fusion assays were the first molecular diagnostic tests specifically authorized for use in both symptomatic and asymptomatic people.^1-2 In 2020 alone, more than 68 million Hologic COVID-19 tests were distributed to over 40 countries. 

"The scale-up was definitely new because instead of thousands, we needed to initially support millions of tests per month,” said Pham. “But we learned and put our best skillsets to use, and I think we came out stronger from it.”

Emerging resilient and ready to fight emerging health threats

To date, Hologic has provided more than 210 million COVID-19 tests globally. The company continues to innovate and expand upon its assays for COVID-19 and other respiratory viruses, and in 2023 it received FDA clearance of a test that can detect SARS-CoV-2, influenza A and B, and RSV from a single patient sample.

Most recently, the company entered into an agreement with the Centers for Disease Control and Prevention (CDC) to develop analyte specific reagents (ASRs) — the “active ingredients” of laboratory-developed tests used to identify specific diseases or conditions — that would aid in the detection of H5N1 bird flu. The ASRs are being developed on the Panther Fusion system, a fully automated molecular testing platform that allows labs to quickly consolidate and run multiple assays for women's health, infectious disease and COVID-19 testing. 

The high-throughput Panther^® system has an extensive presence throughout the laboratory community, with more than 1,700 systems installed in public health laboratories, hospitals and private reference laboratories across the U.S. and over 3,300 worldwide. Many of these systems were placed during the COVID-19 pandemic and each have the ability to generate over 1,000 test results in 24 hours. With this sizeable Panther system footprint and the system’s Open Access® functionality that enables labs to quickly develop their own tests to meet emerging needs, Hologic is prepared to help combat future public health threats. 

“Tough times test — and more importantly, reveal — true character,” says MacMillan. “The way our team responded during the height of COVID-19 was a shining example of this, and it has fundamentally transformed Hologic.”