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Hologic Readying Add-On Module, Respiratory Viral Panels for Panther MDx System

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NEW YORK (GenomeWeb) – Hologic is joining the fray of molecular diagnostics developers keen on multiplex PCR panels, but has opted for a set of mini-panels to debut its forthcoming Panther Fusion platform.

The firm has already begun showing Fusion at conferences and conventions, including the recent American Association of Clinical Chemistry Expo in Philadelphia, where it also presented data in a poster session on the respiratory panels in development.

Described to GenomeWeb in a demo at AACC as a "sidecar," the platform is essentially a hardware addition that attaches to the Panther system.

The Fusion "can be installed as an infield upgrade without disruption to existing workflow and will allow for additional assay menu on board the system," Michael Watts, vice president of investor relations at Hologic, told GenomeWeb in a follow-up email.

Hologic initially described the platform in its 2015 second quarter earnings call, saying at that time the instrumentation work was done but the assay development was ongoing.

The company now expects to launch the Fusion platform outside the US in 2017, with a US launch in late 2017 or in 2018, Watts said.

The new panels include Panther Fusion Flu A/B/RSV, Panther Fusion Paraflu — which tests for parainfluenzas 1, 2, 3 and 4 — and Panther Fusion AdV/hMPV/RV to detect adenovirus, human metapneumoniavirus, and rhinovirus.

The Panther system was launched in Europe in 2010 by the original manufacturer, Gen-Probe, and was cleared by the US Food and Drug Administration in 2012 just as that firm was being acquired by Hologic.

Panther is a random access system that can hold up to 120 samples at a time, continuously running multiple sample types and assays simultaneously. It can also run different assays on a single patient sample, and has the capacity for 72-hour on-board storage of reagents. Hologic claims Panther requires 3.5 hours to obtain the first test results, but it can process 275 samples in 8 hours, and up to 750 in 16 hours.

The system uses Hologic's proprietary transcription-mediated amplification chemistry. This technology amplifies RNA transcript using an RNA polymerase, thus detecting targets that are being actively transcribed. While some have questioned whether this method might cause a lag in early detection of infectious agents, other work, such as a model of HPV screening, has praised the specificity TMA affords.

Still, the Panther system and Hologic's line of Aptima TMA-based tests do not lend themselves to certain kinds of testing, such as multiplex assays and quantitative PCR.

With the Fusion, the firm now adds "real-time PCR technology to allow for additional assay menu, longer on-board stabilities, higher multiplexing, and open channel capabilities," Watts said.

Users will also be able to develop their own PCR-based tests on the platform, he added.

In addition, the firm's design goal for the Fusion is that it will be able to process 320 samples in 8 hours, with the caveat that only Panther Fusion assays are requested in that time.

For the first assays, Hologic has chosen to develop small multiplex respiratory viral panels.

This is an interesting contrast to the larger respiratory panels of BioFire and Luminex, each of which detects 20 targets, or Nanosphere's test, which can detect 16 targets as either a full multiplex panel or in user-defined subsets.

"We saw an unmet need in the market place for a more modular approach," Watts said.

Indeed, larger panels have been criticized over cost and reporting of results, as previously described. Proponents say large syndromic panels are a better way to uncover the true cause of an illness, but some firms, such as Becton Dickinson, have gone the route of smaller, focused panels, to allow physicians more control over test utilization.  

Hologic is best known for its women's health and blood screening assays, and recently added Zika virus tests for patients and for blood donations.

However, the firm has also been developing other infectious disease diagnostics for its Panther system, including tests for Mycoplasma genitalium, herpes simplex 1 and 2, bacterial vaginosis, and candida.

Hologic has also developed a set of virology assays measuring viral loads of HIV-1, hepatitis B, and hepatitis C viruses. These are currently commercially available in Europe. The HIV assay has been submitted to the US Food and Drug Administration and Hologic anticipates a launch in the coming months, Watts said, with HBV and HCV to follow in 2017 and 2018 respectively.

Panther has been the driver of Hologic's molecular diagnostics business, Watts said in an interview earlier this year, and the firm passed its goal of 1,000 global Panther placements sooner than anticipated. Roughly two thirds of those placements are in MDx labs, Watts said at that time.

Hologic's molecular diagnostics sales have also continued to grow, with mid- to high-single-digit gains in the first, second, and third quarters this year.

The addition of the new Zika tests coupled with updated Centers for Disease Control and Prevention and FDA guidelines for Zika testing of pregnant women and blood donations will also likely impact sales, particularly considering that Hologic blood screening tests are currently used by the American Red Cross and the firm claims that Panthers are deployed for sexually transmitted infection testing in over 90 percent of US public health labs. 

Now, those diagnostics labs will have the option to add the Fusion side car and respiratory panels. And, "while the Fusion module does require a Panther system, we also will be able to place full Panther Fusion systems, as well as upgrade the existing Panther fleet," Watts said.