–New myAccess™
Software Allows Laboratory Developed Tests to Run Alongside Hologic’s Commercially
Available IVD Assays–
MARLBOROUGH, Mass., November 8,
2018 – Hologic, Inc. announced today the availability of Open Access™
functionality for its Panther Fusion® system. This enhanced functionality will
allow CLIA-certified laboratories to develop laboratory developed tests (LDTs)
to run on the fully automated Fusion platform.
Laboratories will be able to run their LDTs simultaneously with
commercially available IVD assays, and results will release automatically to
laboratory information systems.
“We know that
our diagnostic lab customers place a high value on flexibility, which is one of
the reasons we launched Panther Fusion with polymerase chain reaction, commonly
known as PCR, capability last year,” said Tom West, president of the Diagnostic
Solutions division at Hologic. “The current software introduction builds on
that launch by providing tools that labs can use to design and use LDTs on a
fully automated platform, as well as consolidate their LDTs with commercial
assays to maximize productivity.”
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. Specifically, the Panther Fusion module adds
the capacity to run PCR assays in addition to tests based on TMA
(transcription-mediated amplification), the proprietary Hologic chemistry that
powers the company’s Aptima® brand.
The Open Access functionality is
enabled by the new myAccess™ software, which is designed to help laboratories create
protocols, analyze data, set thresholds, and interpret results.
The Panther
Fusion system retains all the key benefits of the Panther platform, including
full sample-to-result automation, the ability to run multiple tests from a
single sample, random and continuous access, continuous loading, and STAT
capabilities.
Users of Open Access
are required to follow all applicable CLIA requirements for their laboratory
and users in developing and running their own LDTs on the Panther Fusion system.
About Hologic
Hologic, Inc. is an innovative medical technology company primarily
focused on improving women’s health and well-being through early detection and
treatment. For more information on Hologic, visit www.hologic.com.
Forward-Looking Statements
This
press release may contain forward-looking information that involves risks and
uncertainties, including statements about the use of Hologic’s diagnostic
products. There can be no assurance these products will achieve the benefits
described herein or that such benefits will be replicated in any particular
manner with respect to an individual customer or patient. The actual effect of
the use of the products can only be determined on a case-by-case basis
depending on the particular circumstances and customer or patient in question.
In addition, there can be no assurance that these products will be commercially
successful or achieve any expected level of sales. Hologic expressly disclaims
any obligation or undertaking to release publicly any updates or revisions to
any such statements presented herein to reflect any change in expectations or
any change in events, conditions or circumstances on which any such statements
are based.
Hologic, Panther, Panther Fusion,
Aptima, Open Access and myAccess are trademarks and/or registered trademarks of
Hologic, Inc. in the United States and/or other
countries.
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