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May 11, 2022

Hologic secures US FDA approval for Aptima CMV Quant assay

The Aptima CMV Quant assay was approved to quantify the viral load of CMV among transplant recipients.

US-based medical technology company Hologic has secured approval from the US Food and Drug Administration (FDA ) for its Aptima CMV Quant assay.

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The test was approved to quantify the viral load of cytomegalovirus (CMV) in patients who underwent solid organ or stem cell transplants.

CMV is a common virus and does not usually cause illness in healthy people.

However, CMV infection can turn serious among transplant recipients, who are typically treated with immunosuppressants to prevent transplant rejection.

The newly approved Aptima CMV Quant assay will help in post-transplant pathogen detection and improve patient outcomes. It also expands the company’s existing portfolio of diagnostic and viral load testing for HIV-1, Hepatitis C and Hepatitis B.

Hologic scientific affairs for diagnostic solutions head Karen Harrington said: “It is imperative to have highly accurate, reproducible results to monitor viral load trends of CMV infections over time in plasma of transplant patients.

“Our assay aligns with the international quantitative standards, offering laboratories and healthcare providers confidence in the results each and every time, ultimately helping to enhance patient management and outcomes.”

The Aptima CMV Quant assay has already obtained CE mark for diagnostic and viral load monitoring in Europe.

Hologic diagnostic solutions president Michelle Garsha said: “We have a legacy of innovation in viral load testing, and our Aptima CMV Quant assay is the first in a series of planned quantitative assays to support patient care following transplant surgery.

“We’re committed to providing our laboratory partners with superior solutions that improve workflow efficiency, support provider and patient needs and address the challenges faced by today’s molecular lab.”

Last year, Hologic acquired surgical instrument manufacturer Bolder Surgical.

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Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
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