MARLBOROUGH, Mass.-Monday 14 September 2020 [ AETOS Wire ]
(BUSINESS
WIRE) -- Hologic, Inc. (Nasdaq: HOLX) announced today that its
CE-marked Aptima® HIV-1 Quant Dx assay has been awarded World Health
Organization (WHO) prequalification for testing of dried blood spot
(DBS) samples.
The Aptima® HIV-1 Quant Dx assay can be used with
DBS samples to monitor viral load and disease progression among HIV-1
infected individuals, and to aid in the diagnosis of HIV-1 infected
infants under 18 months. It is the first and only dual-claim assay for
both viral load and early infant diagnosis (EID).
DBS sampling
improves access to HIV diagnostic testing and care, particularly among
HIV-infected populations living in remote areas. DBS samples are more
stable and easily transportable compared to liquid whole blood or plasma
samples. A finger stick or heel prick produces an adequate sample that
is dried on a specially designed card. The DBS samples do not require
refrigeration and when stored properly can withstand extreme conditions,
including excess heat and humidity.
This additional approval is
notable for the African market, where DBS is the primary sample type in
several countries, and is expected to enable countries to expand their
use of the Aptima® HIV-1 Quant Dx assay, the leading assay under
Hologic’s Global Access Initiative (GAI). The GAI launched in 2018 and
offers customers a single, all-inclusive pricing structure with no
upfront cost or capital expenditure. Qualified products include
molecular assays for HIV, Hepatitis B and C, and human papillomavirus
(HPV), as well as the ThinPrep® Pap test for cervical cancer screening.
“With
25 million people infected with HIV in sub-Saharan Africa, there
continues to be an urgent need for access to cost-effective and quality
diagnostic testing,” said Joao Malagueira, vice president, Europe South,
Middle East and Africa. “The ability to test DBS samples underlines
Hologic’s commitment to promote simple, scalable and sustainable
solutions for countries that need it most. The new product extension
will ultimately enhance patient care and allow for partner governments
to mitigate the burden of disease and respond to broader health needs.”
Despite
substantial progress toward the UNAIDS 95-95-95 targets, there continue
to be gaps across the HIV testing and treatment cascade, with 15.7
million people living with HIV who have an unsuppressed viral load
globally1. In addition, children and infants continue to be affected by
the epidemic. In 2019, only 60% of infants born to pregnant women living
with HIV received the recommended HIV test within two months of birth2.
About 86% of the estimated 160,000 children newly infected with HIV in
2018 were in sub-Saharan Africa.3
The DBS sample type is the
second approval Hologic has received from the WHO, following
prequalification of the Aptima® HIV-1 Quant Dx assay for in vitro
diagnostic use with plasma samples in December 2017.
About Hologic’s Global Access Initiative
The
Hologic Global Access Initiative is a partnership with the Clinton
Health Access Initiative, Inc. (CHAI) and MedAccess (backed by the UK
government) to mitigate the burden of viral diseases in areas with high
prevalence by providing greater access to testing using the Panther®
system. Together with these organizations, Hologic delivers a pricing
structure that allows eligible countries to procure testing with an
all-inclusive* ceiling price of $12 per patient test, with no
requirement for capital expenditure. The test result price is inclusive
of all necessary reagents and consumables, instrument placement, service
and maintenance, freight and logistics, and replacement tests.†
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
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, and Aptima
are trademarks and/or registered trademarks of Hologic, Inc. in the
United States and/or other countries.
SOURCE: Hologic, Inc.
*
Testing services do not include ancillary costs, for example those
associated with sample collection, sample transport, laboratory staff
time, laboratory infrastructure, generic lab supplies (e.g., primary
collection tubes, disposable gloves, bleach, bleach bottles, bleach
enhancer, waste bottles), inventory management, or general
administration and overhead costs.
† Replacement tests for one set of controls and calibrators per kit and documented instrument errors.
References:
https://aids2020.unaids.org/chapter/chapter-2-2020-commitments/the-hiv-test-and-treat-cascade. Accessed August 27, 2020.
https://data.unicef.org/wp-content/uploads/2019/07/HIV_Early_Infant_Diagnosis_July2020.xlsx. Accessed August 27, 2020.
https://www.who.int/gho/hiv/epidemic_response/PMTCT/en/. Accessed August 27, 2020.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200914005183/en/
Contacts
Media Contact:
Jane Mazur
+1 508.263.8764 (direct)
+1 585.355.5978 (mobile)
jane.mazur@hologic.com
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