Hologic secures FDA approval for Aptima CMV Quant assay, poised to challenge Abbott, Roche

USA – Hologic, a medical technology company based in the United States, has received FDA approval for its Aptima CMV Quant assay.

The test has been approved to assess cytomegalovirus (CMV) viral load in patients undergoing solid organ or stem cell transplants, allowing Hologic to compete with companies such as Roche and Abbott.

Following last year’s CE mark, the FDA’s approval of the Aptima CMV Quant assay allows Hologic to sell a post-transplant pathogen detection and monitoring test for its Panther system in the United States for the first time.

CMV poses little risk to people with healthy immune systems, with most infections resulting in only mild, if any, symptoms.

CMV infection, on the other hand, can be fatal in transplant recipients, who are typically treated with immunosuppressants to prevent transplant rejection.


The recently approved Aptima CMV Quant assay will aid in the detection of post-transplant pathogens and improve patient outcomes.

It also adds to the company’s existing portfolio of HIV-1, Hepatitis C, and Hepatitis B diagnostic and viral load testing.

Other transplant assays in the pipeline

Hologic intends to work toward the approval of transplant assays for other pathogens, such as the BK virus and the Epstein-Barr virus, in order to provide quantitative assessments of potential threats to patients.

However, the immunosuppressive regimens required to prevent rejection of solid organ and stem cell transplants make patients more vulnerable.

CMV, if left untreated, can result in outcomes such as transplant rejection and death, prompting physicians to screen patients for the pathogen.

Nucleic acid amplification techniques are used in laboratories to detect and quantify CMV, allowing for timely treatment.

Nonetheless, according to Hologic, limited availability of international standards and variation in assay characteristics previously resulted in quantification variation.

In response, the World Health Organization developed an international standard that has been used to calibrate several FDA-approved commercial assays.

Roche’s COBAS AmpliPrep/COBAS TaqMan CMV Test was hailed as the first in-vitro diagnostic test to meet the WHO standard. CMV tests are also available from Abbott Laboratories and Qiagen.

While WHO-standard assays are available, laboratory-developed tests that are not aligned with WHO standards continue to be used.

Hologic’s Aptima CMV Quant assay provides another option and kicks off the company’s efforts to expand in the transplant sector.

Hologic CEO Steve MacMillan discussed the progress of the US$159 million Diagenode acquisition and its implications for the transplant assay strategy during a quarterly results conference call last month.

Last year, Hologic acquired surgical instrument manufacturer Bolder Surgical.

As COVID-19 testing declines, Hologic is looking to transplant assays to help drive growth. Last year, the company used the proceeds from its testing windfall to fund a series of transactions, including the acquisition of Diagenode.

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