Hologic receives European CE marking for its ThinPrep® Genesis processor, an automated system of cytology slides and molecular specimens



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Hologic, Inc. (Nasdaq: HOLX) announced today that the ThinPrep Genesis processor for the preparation of cytology slides and molecular badays has received the CE IVD mark in Europe. The system has increased automation capabilities, as well as ergonomic and chain-of-custody benefits over older instruments. More importantly, the instrument will prepare slides for cytology as well as aliquots for molecular testing, which will reduce manual sample handling.

The Genesis processor is the latest addition to the ThinPrep portfolio, which has revolutionized and increased the accuracy of cervical cancer screening with the first liquid-based Pap test in 1996. Hologic has launched a ThinPrep update 2000 in 2017 and has been approved by the FDA in 2018 for ThinPrep Integrated Imager, which guides cytotechnologists to areas with potential abnormal cells. Studies have shown that computer-aided imaging can increase the sensitivity of suspicious cell detection compared to manual examination of slides.1-4

The launch of the ThinPrep Genesis Processor reflects our ongoing commitment to helping our laboratory customers deliver accurate and reliable results to clinicians and patients, while maximizing their operational efficiency, "said Jan Verstreken, regional president of the laboratory. Hologics, EMEA and Canada. Over the past 30 years, cervical cancer mortality has declined significantly in developed countries, largely thanks to screening programs that identify abnormalities before they become cervical cancer.

The ThinPrep Genesis processor offers the same reliable reliability as the ThinPrep 2000 system for the treatment of cytology slides, with additional features such as automated aliquoting for molecular testing. The processor also provides automated barcode samples, ensuring accurate sample tracking and reducing the number of manual steps. Increased automation should offer ergonomic benefits by reducing repetitive strain.

To learn more about ThinPrep Pap test products, please visit: https://healthdxs.com/en/thinprep/.

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About Cervical Cancer and Pap + HPV Pap smears

Hologic is a leading European provider of Pap tests (ThinPrep) and HPV tests (Aptima). These tests can be used on the same sample to screen for pre-cancer of the cervix and cancer (independently or together for the co-test: Pap + HPV test together).

The 2018 data indicates that in Europe, more than 60,000 women have been diagnosed with cervical cancer and about 25,000 have died.5 Before the introduction of the Pap test, cervical cancer was the leading cause of cancer death among women in Europe.th in frequency.5

About eight in ten women will contract HPV, the virus that causes cervical cancer, at some point in their lives, but the virus goes away most of the time. In some cases, however, it may remain and promote the development of cervical cancer. For women aged 30 to 65 years, the simultaneous screening method has been shown to detect 95% of cervical cancer cases.6 Screening with both tests also avoids more cases of pre-cancer than both tests alone.6 In fact, the largest retrospective study of cervical cancer screening strategies found that one out of five cases of cancer had not been considered when the HPV test was used alone.6

More information on the interest of the co-test is available on PapPlusHPV.com.

About Hologic

Hologic, Inc. is an innovative medical technology company that focuses primarily 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 regarding the use of Hologics diagnostic products. There can be no badurance that these products will obtain the benefits described in this document or that these benefits will be replicated in any way 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 circumstances and the patient in question. In addition, there can be no badurance that these products will be commercially successful or achieve the expected level of sales. Hologic expressly disclaims any obligation or commitment to post updates or revisions to the statements contained herein to reflect any changes in expectations or changes in the events, conditions or circumstances on which such statements are based.

Hologic, ThinPrep, Aptima and The Science of Sure are trademarks and / or registered trademarks of Hologic, Inc. in the United States and / or other countries.

References

  1. Dziura B, et al. Performance of an imaging system compared to manual screening in the detection of squamous intraepithelial lesions of the cervix. Acta Cytol. 2006; 50 (3): 309-11.
  2. Lozano R. Comparison of computer-badisted screening and manual of cervical cytology. Gynecol Oncol. 2007; 104 (1): 134-8.
  3. Miller FS et al. Implementation of the ThinPrep imaging system in a high volume metropolitan laboratory. Cytopathol diagnosis. 2007; 35 (4): 213-7.4.
  4. Klug SJ, et al. A randomized trial comparing conventional cytology with liquid cytology and computer badistance. Int J Cancer. 2012; 132 (12): 2849-57. doi: 10.1002 / ijc.27955.
  5. ICO / IARC Information Center on HPV and Cancer (HPV Information Center). Report on the Human Papillomavirus and Related Diseases, April 17, 2018. http://www.hpvcentre.net/statistics/reports/XEX.pdf1
  6. Blatt et al. Comparison of cervical cancer screening results among 256,648 women in several clinical practices. Cytopathology of cancer. 2015; 123 (5): 282-288 [Study included ThinPrep, SurePath, Hybrid Capture 2 baday].

SOURCE: Hologic, Inc.

Investor contact:
Michael Watts
+1 858.410.8588
[email protected]

Media contact:
Jane Mazur
+1 508.263.8764 (direct)
+1
585.355.5978 (mobile)
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