Ability to load primary sample tubes eliminates manual transfer of specimen. The fdaapproved instrument operator manual for hologic panther and panther fusion systems includes a prominent warning against using. Hologic to introduce its second highthroughput molecular. Hologic launches new scalable options for panther system in. Utilize existing panther system lis connection for panther fusion assays, reducing lis costs.
Jun 18, 2018 the fusion module is an inlab upgrade to hologic s panther instrument, which enables labs to extend the testing capabilities of their existing panther, hologic said. Hologic adds functionality to panther fusion cap today. This highthroughput molecular diagnostic platform combines comprehensive sexual health, cervical health, viral load, respiratory testing and open channel functionality on a fully automated system. The panther fusion system, available in the us, is a powerful molecular testing instrument that joins pcr and tma capabilities to give your lab multiple valuable. Hologic product catalog hologic pdf catalogs technical. January 2019 hologic announced the availability of open access functionality for its panther fusion system. The panther fusion system allows you to run both pcr and tma assays, increase walkaway freedom, enhance flexibility and evolve your labs efficiency. Evaluation of the hologic genprobe panther, aptima combo 2. Specifically, the panther fusion module adds the capacity to run pcr assays in addition to tests based on tma transcriptionmediated amplification, the proprietary hologic. Hologics panther fusion flu advhmpvrv assay wins fda nod. Hologic receives ce mark for panther fusion system and assays. Hologics molecular test for the novel coronavirus, sarscov2. Consolidate your pcr testing with a growing menu of panther fusion assays on. Holx provides a comprehensive suite of technologies with products for mammography and breast biopsy, breast magnetic resonance imaging, radiation treatment for earlystage breast cancer, cervical cancer screening, treatment for menorrhagia and uterine fibroids and polyps, osteoporosis assessment.
Process 335 panther fusion assays or combine panther fusion and aptima assays for up to 500 tests in 8 hours. This assay, the latest in a growing menu of panther fusion and aptima assays, brings full automation, efficiency and excellent assay performance to bordetella detection. This enhanced functionality will allow cliacertified laboratories to develop laboratorydeveloped tests to run on the fully automated fusion platform. The enhanced functionality will allow cliacertified laboratories to develop laboratorydeveloped tests to run on the fully automated fusion platform. The gbs assay has also been cemarked for diagnostic use and is commercially available in europe. In response to the desperate public need for rapid highvolume testing we have developed the panther fusion sarscov2 assay, which enables labs to run up to 1,150 tests in 24 hours and attain a timetofirst result in 2. Laboratories will be able to run their ldts simultaneously with commercially available ivd assays, and results will release. Readyto use reagent cartridges reduce manual preparation and operator errors. The panther fusion bordetella assay is the latest addition to the suite of panther fusion respiratory assays on the fully automated panther fusion system. The aptima sarscov2, panther fusion sarscov2, and aptima sarscov2flu assays are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection andor diagnosis of covid19 under section 564b1 of the act, 21 u.
Hologic announces fda clearance of the panther fusion gbs assay. This animation was created specifically for hologic. The panther fusion sarscov2 assay on the panther fusion system is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the operation. The panther fusion system represents the latest innovation in hologic. Readytouse reagent cartridges reduce manual preparation and operator errors. The panther fusion system is designed as an inlab upgrade to improve the testing capabilities by adding flexibility of polymerase chain reaction pcr to current panther systems transcriptionmediated amplification tma. The fullyautomated hologic panther instrument brings workflow flexibility, high. Hologic panther fusion consolidate molecular testing. The panther instrument is a fully automated sampletoresult instrument, eliminating the need for batch processing and automates all aspects of nucleic acid testing on a single, integrated platform.
Fda warns of cyanide gas danger with improper use of hologic. Sarscov2 rapid test for diagnostic use now available hologic. The panther fusion bordetella assay is a realtime pcr assay for the detection and differentiation of bordetella pertussis b. Holx announced today that it has received fda clearance for its group b streptococcus gbs assay on the panther fusion system. Hologic is a global champion of womens health, we integrate the science of sure into everything we do to help improve and save lives through early detection and proactive treatment. Apr 29, 2020 the panther fusion system, an addon module to the base panther platform, uses polymerase chain reaction pcr chemistry to perform hologic s suite of respiratory assays such as influenza. The panther fusion is available as a full system or the panther fusion module can be attached to existing panther systems in the. Aug 02, 2018 systems latest assay increases lab efficiency and flexibility with highly sensitive and specific detection marlborough, mass.
Introduction we are ologic h the womens health company hologic, inc. The aptima and panther fusion assays help guide patient care and enable early detection. There is no need to batch any tests or wait for optimal volumes with continuous sample and reagent loading. The panther fusion system retains all the key benefits of the panther platform, including full sampletoresult. Health canada approves hologic panther fusion system. Reagents stored onboard the panther system have 72 hours of onboard stability. Hologic testing was performed using pooled samples generated from samples. Minimize user interaction and return visits to the system with bulk onboard reagents. Panther panther fusion system operators manual aw18851001 rev. All users must make sure that they receive training on correct operation of the system before use on patients.
Discard any unused reconstituted reagents and wtcr after 30 days or after the master lot expiration date, whichever comes first. The panther can be test samples with random access or batch managed. Process 335 panther fusion tests or combine panther fusion and aptima assays for up to 500 tests in 8 hours. Apr 29, 2020 in march 2020, hologic received emergency use authorization for its first covid19 test, the panther fusion sarscov2 assay. Refer to the panther panther fusion system operators manual for. This is a multiplex assay that runs on the new panther fusion system and detects. Hologic panther r fusion tm, catalog number asy09600 product usage. Refer to the pantherpanther fusion system operators manual for. Evaluation of the hologic genprobe panther, aptima combo. The performance of panther was compared with the hologic genprobe tigris andor roche indianapolis, in cobas amplicor systems through testing of patient specimens and the spikedurine matrix. Hologic does not accept the responsibility for injury or damage from incorrect system operation.
Unprecedented flexibility panther fusion system hologic. Evolve the laboratorys capability for molecular testing with the addition of the full panther fusion system or add the panther fusion module to the existing panther system. The panther fusion gbs assay joins the panther fusion flu abrsv, panther fusion paraflu, and panther fusion advhmpvrv assays, all of which received fda clearance in 2017. To evaluate the performance of the hologic genprobe san diego, ca panther system. Holx provides a comprehensive suite of technologies with products for mammography and breast biopsy, breast magnetic resonance imaging, radiation treatment for earlystage breast cancer, cervical cancer screening, treatment for menorrhagia and uterine fibroids and polyps, osteoporosis assessment, preterm birth. Pantherpanther fusion system operators manual aw18851001 rev. Hologics new panther fusion system gets health canada nod. The panther fusion system, an addon module to the base panther platform, uses polymerase chain reaction pcr chemistry to perform hologic s suite of respiratory assays such as influenza. If passed from a mother to her baby during labor, it can lead to serious health consequences for the newborn and even death from illnesses. Hologic panther fusion community, manuals and specifications. Refer to the pantherpanther system operators manual for additional. Panther fusion respiratory assays first year user perspective. The panther fusion system joins the flexibility of pcr with the power of tma to give the lab multiple valuable chemistries on a single platform. Experience freedom and control over your molecular testing workflow like never before with the panther system from hologic.
Protect your highperformance hologic system with the best service and support team in the industry. Gbs is a bacterium naturally carried by some women. Hologic launches new scalable options for panther system. Hologic receives ce mark for panther fusion system and. Video introducing the panther fusion system, evolution of the panther system, and system featuresbenefits. Ddstudio was to design a range of concepts that addressed user needs, marketing objectives, functional requirements, and cost targets, as well as. Hologic 3dimensions user manual pdf download manualslib. Hologics panther fusion flu advhmpvrv assay wins fda. Hologic panther fusion flu abrsv assay cleared by fda. Comparison of the panther fusion and allplex assays for. The panther fusion respiratory menu, available in the us, allows for syndromic respiratory testing for the most common respiratory viruses including flu a and b, rsv, adv, hmpv, rv and parainfluenza 14. Inlab upgrade increases test volumes, throughput and menu without replacing equipment or infrastructure. After discrepant resolution, panther demonstrated a 99.
Hologics new panther fusion system, flu and respiratory. Jun 29, 2017 hologic has received ce mark for the new panther fusion system and its assays developed for flu and respiratory testing. The eluate is transferred to the panther fusion system reaction tube containing the assay reagents. Panther fusion open access is a nonivd function that is not required to have fda clearance or approval. This fully automated platform provides test consolidation, randomaccess sample loading and proven assay chemistry to deliver high performance and results you can trust. Get further information on the panther fusion system and panther fusion assays. The virtual camera that elara creates in this piece enables complete flexibility and control over the visualization. Multiplex rtpcr is then performed for the eluted nucleic acid on the panther fusion system. Prior to processing and testing on the panther fusion. Holx announced the receipt of 510k clearance from the fda for its panther fusion advhmpvrv assay. Hologic service and support delivers proven expertise to improve your business results and most importantly, patient outcomes.
Develop your own assays and protocols with open acesss. The panther fusion system retains all the key benefits of the. Unparalleled automation panther fusion system hologic. Nov 08, 2018 the panther fusion is available as a full system, or the panther fusion module can be attached to existing panther systems in the field to extend testing capabilities. Holx recently announced the receipt of health canada approval for the new panther fusion system and panther fusion assays for. Hologic adds open access functionality to panther fusion.
Controls are stable until the date indicated on the vials. Hologic engaged with ddstudio to design and develop the panther fusion module addition to panther system which would be sold as a full system or as a module upgrade to the existing panther systems. Feb 05, 2020 hologic s panther and panther fusion systems now offer 16 fdacleared assays and 20 cemarked assays that detect more than 20 pathogens. Ready touse reagent cartridges reduce manual preparation and operator errors. Utilize unit dose, lyophilized reagents to achieve 60 day onboard stability. Dec 27, 2019 respiratory viral infections are the most frequent clinical syndrome affecting both children and adults, and early detection is fundamental to avoid infectionrelated risks and reduce the healthcare costs incurred by unnecessary antibiotic treatments. Hospital, public health and reference laboratories can perform the test on hologics panther. Prevention of perinatal group b streptococcal disease. Run independently or as part of a panel on the panther fusion system, with true, patientspecific results. The panther fusion system is a full, randomaccess system that gives you access to 32 different assays simultaneously.
With full random access, you can continuously load up to 120 patient samples in any assay combination. Panther fusion sarscov2 assay instructions for use fda. Their panther fusion system is an integrated molecular testing solution for diagnostic laboratories. The emergence of sarscov2 was unforeseen, and the worldwide outbreak of covid19 has already impacted thousands. Aptima multitest tube to a panther fusion specimen lysis tube, hologic. The module adds the flexibility of pcr to the proven performance of transcriptionmediated amplification used by the panther system, the firm said. Comparison of the panther fusion and allplex assays for the. Mar 16, 2020 the panther fusion system provides an expanded in vitro diagnostics menu, as well as open access tm functionality to run laboratory developed tests. The fusion module system offers laboratories the ability to extend the testing capabilities of the existing panther system. Hologic s panther and panther fusion systems now offer 16 fdacleared assays and 20 cemarked assays that detect more than 20 pathogens. The aptima sarscov2, panther fusion sarscov2, and aptima. In this study, performance characteristics of two commercial methods, the panther fusion assay hologic inc.
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