Hologic receives FDA approval for Cervista HTA system to detect cervical cancer

Hologic, Inc. (Hologic or the Company) (Nasdaq: HOLX), a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, announced today that the U.S. Food and Drug Administration (FDA) has approved its Cervista HTA (high throughput automation) system for use with the Company's previously approved Cervista human papillomavirus (HPV) HR test. The Company's HPV HR test utilizes Hologic's proprietary Invader technology to detect 14 high risk types of HPV that are associated with cervical cancer and precancerous lesions.

The Company's Cervista HTA system automates the DNA extraction and detection steps of the Hologic Cervista HPV HR test allowing users to walk away after loading the instrument and return the next morning to review the test results.

"Our new Cervista high throughput automation system represents a significant addition to our molecular diagnostics product portfolio," said Rob Cascella, President and Chief Executive Officer of Hologic. "The Cervista HTA system automates our Cervista HPV HR test, providing higher throughput, improved chain of custody and accurate results. We are extremely pleased to get this product approved as it materially changes the competitive landscape for Hologic."

"With over 200 U.S. laboratories currently running our Cervista HPV HR test, we have had tremendous success with the early adoption of our manual HPV test," said Rohan Hastie, Vice President and General Manager, Hologic Molecular Diagnostics. "We believe that our success is driven in large part by physician and laboratory confidence in the performance and comprehensive design of the Cervista HPV assays. Having HTA approved quite simply makes us even more competitive."

Source:

Hologic, Inc.

Citations

Please use one of the following formats to cite this article in your essay, paper or report:

  • APA

    Hologic, Inc.. (2019, June 20). Hologic receives FDA approval for Cervista HTA system to detect cervical cancer. News-Medical. Retrieved on February 03, 2023 from https://www.news-medical.net/news/20111216/Hologic-receives-FDA-approval-for-Cervista-HTA-system-to-detect-cervical-cancer.aspx.

  • MLA

    Hologic, Inc.. "Hologic receives FDA approval for Cervista HTA system to detect cervical cancer". News-Medical. 03 February 2023. <https://www.news-medical.net/news/20111216/Hologic-receives-FDA-approval-for-Cervista-HTA-system-to-detect-cervical-cancer.aspx>.

  • Chicago

    Hologic, Inc.. "Hologic receives FDA approval for Cervista HTA system to detect cervical cancer". News-Medical. https://www.news-medical.net/news/20111216/Hologic-receives-FDA-approval-for-Cervista-HTA-system-to-detect-cervical-cancer.aspx. (accessed February 03, 2023).

  • Harvard

    Hologic, Inc.. 2019. Hologic receives FDA approval for Cervista HTA system to detect cervical cancer. News-Medical, viewed 03 February 2023, https://www.news-medical.net/news/20111216/Hologic-receives-FDA-approval-for-Cervista-HTA-system-to-detect-cervical-cancer.aspx.

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post
You might also like...
Hologic’s Cynosure division partners with Porter Instrument to distribute nitrous oxide and oxygen system