Hologic Announces European CE Mark for Molecular Assays for Use with Transplant Patients
May 25 2022 - 8:02AM
Business Wire
-- New quantitative assays for Epstein-Barr
Virus and BK Virus expand Hologic’s Panther Fusion transplant
pathogen monitoring menu --
Hologic, Inc. (Nasdaq: HOLX) announced it has
received CE marking for two new molecular assays, Panther Fusion
EBV Quant Assay and Panther Fusion BKV Quant Assay, expanding its
transplant pathogen monitoring menu on the Panther Fusion system.
The assays quantify the viral load of the respective viruses and
are intended to aid the diagnosis and management of solid organ
transplant patients and hematopoietic stem cell transplant
patients.
The assays are in vitro nucleic acid amplification tests (NAAT)
that are run on the fully automated Panther Fusion system using
real-time Polymerase Chain Reaction (PCR) technology. The Panther
Fusion EBV Quant is validated for use with whole blood and plasma
samples. The Panther Fusion BKV Quant is validated for use with
human plasma and urine samples. Plasma, whole blood and urine
specimens are important biomarkers when using quantitative NAATs
for diagnosis and management of transplant patients. It is crucial
that viral levels are accurately quantitated in transplant
recipients to guide treatment decisions and monitor response to
therapy.1,2
“Immunocompromised patients are vulnerable to a range of
infections. As both the Epstein-Barr virus (EBV) and the BK virus
(BKV) are extremely common and mainly asymptomatic, it is important
that healthcare providers can quantitate and monitor for their
presence,” said Jan Verstreken, Group President, International at
Hologic. “These assays, along with our Aptima CMV Quant assay that
we launched in Europe last year, provide our laboratory partners
with the tools they need to accurately assess transplant patient
samples quickly and confidently.”
“These two assays represent two firsts for us. They are the
first quantitative assays developed for the Panther Fusion system,
further expanding our existing portfolio of diagnostic and viral
load tests. They are also the first Panther Fusion assays developed
in our R&D facility in Liege, Belgium, which we acquired last
year,” concluded Verstreken.
For more information on the Aptima and Panther Fusion assays,
visit www.hologic.com.
About Epstein-Barr Virus
EBV is a ubiquitous virus that belongs to the herpesvirus
family. It is estimated that 90% of the population worldwide is
infected with EBV.3 In immunocompromised people such as transplant
patients, it is a significant cause of morbidity and mortality.
About BK Virus
BKV is a highly prevalent human polyomavirus that belongs to the
papoviridae family. Primary exposure to BKV occurs in childhood,
resulting in 80-90% of adults having developed antibodies against
BKV. The majority of BKV infections are asymptomatic, with the
virus remaining latent in the urinary tract.4 Viral reactivation
occurs in immunocompromised individuals, frequently in renal
transplant and hematopoietic stem cell transplant patients, and is
associated with nephropathy, ureteral stenosis and late onset
haemorrhagic cystitis.5
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.
Hologic 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 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 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, The Science of Sure, Aptima, Panther Fusion and
associated logos are trademarks and/or registered trademarks of
Hologic, Inc. in the United States and/or other countries.
Source: Hologic, Inc.
References
- Nijland, ML, Kersten MJ, Pals ST, Bemelman FJ, ten Berge JJM.
2016 Transplantation Direct 2016;2: e48 doi:
10.1097/TXD.0000000000000557.
- Hirsch HH, Randhawa PS, AST Infectious Diseases Community of
Practice. 2019. BK polyomavirus in solid organ
transplantation–Guidelines from the American Society of
Transplantation Infectious Diseases Community of Practice. Clin
Transplant. Sep;33(9): e13528.doi:10.1111/ctr.13528. Epub 2019 Apr
10. PMID:30859620.
- Tzellos S, Farrell PJ. 2012. Epstein-Barr Virus Sequence
Variation—Biology and Disease. Pathogens. 1(2):156–174.
doi.org/10.3390/ pathogens1020156.
- Muhsin SA, Wojciechowski D. 2019. BK Virus In transplant
recipients: current perspectives. Transpl Res Risk Manag.
11:47-58.
- van Aalderen MC, Heutinck KM, Huisman C, et al. 2012. BK virus
infection in transplant recipients: clinical manifestations,
treatment options and the immune response. Neth J Med.
May;70(4):172-183. PMID:264162.
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