Hologic Inc, Marlborough, Mass, has received premarket notice (510(k)) clearance from FDA for its Panther Fusion Flu A/B/RSV test running on the company’s new Panther Fusion system.
The Panther Fusion is accessible as a full system or the Panther Fusion module can be connected to existing Panther systems in the field to extend testing capacities. In particular, the Panther Fusion adds the ability to run polymerase chain reaction (PCR) examines in addition to tests based on Hologic’sproprietary transcription-mediated amplification (TMA) chemistry, which additionally controls the company’s Aptima image.
Tom West, president of the diagnostic solutions division at Hologic says, “Merging testing remains a key concentration of our clinical research center clients. Offering numerous chemistries on a single platform grows menu while enabling labs to additionally consolidate testing and meet efficiency objectives.”
The Panther Fusion system holds all the key advantages of the Panther platform, including full sample-to-result automation, the capacity to run numerous tests from a single sample, random access sample processing, continuous loading, and stat capabilities. Additional advantages incorporate a higher throughput of up to 335 Panther Fusion tests, or up to 500 Fusion and Aptima tests, in 8 hours.
The Panther Fusion Flu A/B/RSV assay is the first of three respiratory panels Hologic is creating for use on the Panther Fusion systemand will be followed by the Panther Fusion Parafluassay and the Panther Fusion adenovirus/human metapneumovirus/rhinovirus (AdV/hMPV/RV) test. When every one of the three Panther Fusion respiratory panels receivesFDA clearance, they will offer a modular way to testing with ability by means of the capacity to run one, two, or each of the three assays from a single patient specimen. The Panther Fusion assays likewise use ready-to-use reagents, which present 60-day onboard stability.
West said, “We have heard notification from customers that many panels as of now available are too large, requiring them to run up to at least 20 targets when maybe a physician has just asked for three or four. Not only is this time-consumingfor the lab, it is likewise not cost-effective. By offering three littler panels focused on the tests most frequently asked for, we will offer labs maximum adaptability to design test runs to meet particular needs.
“Hologic has long-standing expertise in influenza reaching out back to the presentation of ProFlu+, the first FDA-cleared Flu A/B/RSV assay available on the market, in 2008,” includes West. “This expertise has meant the advancement of a test with excellent performance, and that test is presently accessible on our integrated platform, which completely automates all parts of testing, from sample to result.”
The Panther Fusion system generously decreases the hands-on time for laboratories by providing random and consistent access with rapid turnaround time. The new Panther Fusion PCR-based assays joined with select Aptima TMA assays, make the Panther Fusion system the main instrument worldwide that consolidates TMA, real-time TMA, and real-time PCR with full sample-to-result automation.
In Europefor diagnostic utilize and are commercially accessible, the Panther Fusion Flu A/B/RSV, Panther Fusion system, Paraflu, and AdV/hMPV/RV assays have additionally CE-marked.