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Hologic Wins CE Mark for Saliva-Based Covid-19 Test

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Intelligent Fingerprint also announced it had developed a saliva-based test for the European market.

Hologic can now use saliva samples with its COVID-19-related tests in Europe. The Waltham, MA-based company said it won CE Mark to use the aforementioned samples with the Aptima SARS-CoV-2 assay.

Aptima is a molecular diagnostic assay that detects the genetic material of the pathogen causing COVID-19 and runs on the fully-automated Panther system.

“This new CE Mark demonstrates our commitment to providing European consumers and healthcare providers as many options as possible to manage the ongoing pandemic,” said Jan Verstreken, Hologic’s group president, International. “While vaccination is helping stem the tide of COVID-19, we envision that testing will continue to play an important role, particularly in screening programs needed to reopen society.”

Aptima was one of the first COVID-19-related tests to win emergency use authorization in the U.S. The firm has shipped more than 100 million Aptima COVID-19 tests globally since the spring of 2020. About 2,600 Panther systems have been installed in clinical diagnostic laboratories around the world.

Hologic isn’t the only company announcing a saliva-based test for the market in Europe. Intelligent Fingerprint’s test uses a simple swab to collect a saliva sample just from the inside of the cheek. The London-based company’s test strip is deliberately simple in design and engineered to keep plastic usage to a minimum - with none of the plastic casing present that is usually associated with lateral flow tests.

“Almost everyone who has taken a nose or throat swab to test for COVID-19 knows just how unpleasant they can be. In developing our new COVID-19 saliva test, we have successfully combined the benefits of much simpler sample collection with high levels of accuracy using our existing technology,” said Intelligent Fingerprinting’s Executive Chairman Philip Hand.


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