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Hologic Focusing New MDx Development on PCR-Based Fusion Module for Panther Testing System


NEW YORK – While sales of Hologic's transcription-mediated amplification (TMA)-based Panther molecular testing system soared during the height of the pandemic, sales have slowed, and the company is now focused on developing new PCR tests that run on its Panther Fusion modules.

Hologic CEO Steve MacMillan has said in recent earnings calls that Hologic increased its installed Panther base by 75 percent since the COVID-19 pandemic began, to more than 3,260 installed instruments. In November 2023, he said in an earnings call that the company expected sales of new Panther instruments would be low to almost immaterial in the next few years, but that it was working to sell Panther Fusion add-on modules, or so-called "sidecars," to existing customers to expand the existing Panther test menu. The company is simultaneously working to increase customer use of the existing TMA-based assay menu.

More recently, Jennifer Schneiders, president of diagnostic solutions for Hologic, said that the Marlborough, Massachusetts-based firm is still improving existing TMA-based Aptima assays for the Panther by expanding compatible sample types such as self-collected samples for sexually transmitted infection tests. However, all newer tests are being developed for the Fusion.

"Certainly, there's always on-market support, improvement, and additional capabilities for current Panther assays," she said. "But the new innovation, completely new product development is Fusion-focused for molecular."

Schneiders added, though, that Hologic still sees potential in the Panther and the company's R&D team can still choose which technology is best suited to new assays.

New molecular assays will include a panel that she said will help labs consolidate testing for bacterial and viral gastrointestinal infections onto Hologic's instruments. However, she said the company isn't ready to announce a time frame for that panel's launch.

Hologic executives noted during the November earnings call that about 20 percent of installed Panthers had attached Fusion modules and that figure was growing. Schneiders likewise added that Fusion sales have accelerated in the past year.

Hologic's base-model Panther instrument is a random-access system that eliminates batch constraints for sample loading. It holds up to 120 samples and can process up to 320 samples in eight hours and 750 in 16 hours.

The Fusion system has a 28-cartridge capacity, with up to 12 reactions per cartridge and a throughput of 335 tests in eight hours. A lab can run a combined total of up to 500 Fusion and Aptima tests in eight hours and up to 960 in 16 hours, according to the company website.

The Panther and Panther Fusion have a combined menu of about 20 assays, most of them TMA assays for women's health and infectious disease. The PCR menu mostly consists of respiratory assays and a few Streptococcus assays, although users can also develop their own PCR-based tests on Fusion due to its open-access or open-channel capability. However, Schneiders said customers typically buy the module for Hologic's tests and the promise of future menu expansion.

"It does take a certain special capability within the customer segment to be able to develop their own LDTs," she said. "We do have some of that going on, but the majority are using what we have launched."

Hologic has also previously announced plans to adapt to the Panther Fusion a series of assays that it gained in 2021 through its $159 million acquisition of Diagenode, especially tests for hospital-acquired, gastrointestinal, and respiratory infections. At the time of the acquisition, Diagenode sold more than 30 CE-marked real-time PCR tests, and company officials said bringing those tests to the Panther Fusion would require adapting them to the Panther's automated format.

The Panther and Panther Fusion compete against high-throughput, automated molecular diagnostics instruments such as the Becton Dickinson BD Cor, Abbott Alinity M, and Roche Cobas.

Though Panther sales picked up in recent years during the global response to SARS-CoV-2, the instrument is in its second decade on the market. Gen-Probe launched the analyzers 14 years ago in Europe and 12 years ago in the US, and Hologic brought them into its portfolio in 2012 through its $3.7 billion acquisition of Gen-Probe.

Panther launched as a fully automated instrument targeted at low- to mid-volume labs, and its patented TMA-based assays were intended to become the cornerstone of Hologic's molecular diagnostics franchise.

However, the company launched Panther Fusion just a few years later in 2016 with PCR-based respiratory assay panels for targets including influenza A/B, respiratory syncytial virus, parainfluenza, adenovirus, human metapneumovirus, and rhinovirus. Those respiratory panels have remained the primary applications for Fusion, and Hologic also secured its first US Food and Drug Administration Emergency Use Authorization for a COVID-19 test on Fusion.

Schneiders said that company officials made that first test for the Fusion before they realized how widely SARS-CoV-2 would spread. Once the firm realized it would need higher-volume test manufacturing capacity, it pivoted to creating a TMA assay for the Panther.

"We have built, since the pandemic, more manufacturing capability all around," she said. "But at that time, we had more capability to manufacture at much higher volumes TMA versus the Fusion."

In 2021 the firm expanded its molecular portfolio yet again with its $795 million acquisition of Mobidiag, although Schneiders noted that Mobidiag's Novodiag PCR instruments use different technologies from the Fusion. Specifically, those platforms combine real-time PCR and microarrays for highly multiplexed detection of pathogens from a single sample.

On the high-throughput front, however, Schneiders said Hologic sees in the Panther Fusion opportunities for labs to consolidate testing using the company's 20-plus molecular assays. Most customers with installed Panthers run at least four TMA assays, PCR assays, or a combination, she said.

"That's what we're focusing on with customers now is consolidating testing, [and] adding more menu to the Panther and Fusion," she said.