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Cervical Cancer Screening Portfolio

Evolving methods, one goal: the prevention of cervical cancer

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Challenge

Cervical cancer: the 4th most frequent cancer in women1

While preventable, cervical cancer takes a heavy toll1. The high mortality rate from cervical cancer globally could be reduced through a comprehensive approach that includes prevention, early diagnosis, effective screening and treatment programs.1

~570,000

~570,000

women diagnosed worldwide per year1

~311,000

~311,000

deaths worldwide per year1

SOLUTION

BD offers assays and instruments to support the cervical cancer screening needs of today and tomorrow.

The added complexity due to the HPV vaccination, in conjunction with the variability of screening methods, underscores the importance of a medical technology partner fully able to support and adapt to the requirements of healthcare providers and laboratories.

HPV Primary
HPV Primary

The BD Onclarity™ HPV Assay provides:

  • DNA-based PCR assay with proven and validated performance3
  • Internal cellularity control to minimize false-negative results
  • Enhanced genotyping to allow risk stratification and reduce unnecessary colposcopies


The BD SurePath™ Liquid-based Pap Test provides:
 

  • An FDA approved collection vial for HPV primary screening

Contact us to discuss how we can support your cervical cancer screening needs.

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        Hear what patients just like you have to say.
        quote-icon
        Excellent needles with great value for me needs

        It was a good purchase without spending an arm and a leg to get these. I used to spend $40-50 for one box. They are the same brand/style as the expensive ones. I’m satisfied at how fast they arrived. 

        —

        Nancy Paladino, Caregiver

        References
        1. World Health Organization. Cervical Cancer. Available at: https://www.who.int/cancer/prevention/diagnosis-screening/cervical-cancer/en. Assessed on September 25, 2019.
        2. Nance KV. Diagn Cytopathol. 2007; 35:148-153.
        3. BD Onclarity HPV Assay [US Package Insert 8089894] Sparks, MD: Becton, Dickinson and Company, 2020.
        4. BD Surepath Collection Vial [US Package Insert 500017013] Sparks, MD: Becton, Dickinson and Company, 2020.
        Extend the power of HPV testing
        ASSAYS
        Extend the power of HPV testing

        The BD Onclarity™ HPV Assay provides extended high-risk HPV genotyping results beyond 16 and 18, to support risk stratification and enhanced patient management

        ASSAYS

        BD Onclarity™ HPV Assay

        Extended genotyping supports risk stratification and persistence monitoring to guide patient management7-11

        • Genotypes 16 and 18 account for 70% of invasive cancer worldwide, but the prevalence of these genotypes is declining as vaccination rates increase1-5
        • Genotypes 31/33/58 have a CIN3+ risk similar to genotype 18, but 51/35/39/68/59/56/66 have a much lower risk6,7
        • The BD Onclarity™ HPV assay reports individual results for 6 of the 14 high-risk genotypes and grouped results for the remaining 8 high-risk genotypes8
        1. World Health Organization, Department of Reproductive Health and Research. Cervical cancer, human papillomavirus (HPV), and HPV vaccines—key points for policy-makers and health professionals. 2007.  
        2. Oliver SE et al. J Infect Dis. 2017;216(5):594–603.  
        3. Drolet M et al. Lancet Infect Dis. 2015;15(5):565–580.  
        4. Garland SM et al. Clin Infect Dis. 2016;63(4):519–527.  
        5. Stoler et al. Clin Infect Dis. 2019 ;153(2) :259-265.  6. Schiffman M et al. Gynecol Oncol. 2015;138(3):573–578.  
        6. Schiffman M et al. Int J Cancer. 2016;139(11):2606–2615.  
        7. BD Onclarity HPV Assay US Package Insert [8089894]  
        8. Osbourne et al. Vaccine. 33(2015)201-208.  
        9. Stoler MH et al. Gynecol Oncol. 2019;153(1):26–33.  
        10. Bonde J et al. Int J Cancer. 2019; doi:10.1002/ijc.32291.  
        11. Elfgren K et al. Am J Obstet Gynecol. 2017;216(3):264.e1–264.e7.  
        12. Radley D et al. Hum Vaccin Immunother. 2016;12(3):768–772.  
        13. Bottari F et al. J Low Genit Tract Dis. 2019;23(1):39–42.  
        14. Perkins RB, Fuzzell LN, Lake P, McIntyre M, Nayar R, Saraiya M, Loukissas J, Felder T, Guido RS, Vadaparampil ST. Incorporating Stakeholder Feedback in Guidelines Development for the Management of Abnormal Cervical Cancer Screening Tests. J Low Genit Tract Dis. 2020 Apr;24(2):167-177. doi:10.1097/LGT.0000000000000524. PMID: 32243312; PMCID: PMC7147423.  
        15. Gage JC, Schiffman M, Katki HA, Castle PE, Fetterman B, Wentzensen N, Poitras NE, Lorey T, Cheung LC, Kinney WK. Reassurance against future risk of precancer and cancer conferred by a negative human papillomavirus test. J Natl Cancer Inst. 2014 Jul 18;106(8):dju153. doi: 10.1093/jnci/dju153. PMID: 25038467; PMCID: PMC4111283.  
        16. Wright TC Jr, Stoler MH, Parvu V, Yanson K, Cooper C, Andrews J. Risk detection for high-grade cervical disease using Onclarity HPV extended genotyping in women, ≥21 years of age, with ASC-US or LSIL cytology. Gynecol Oncol. 2019 Aug;154(2):360-367. doi: 10.1016/j.ygyno.2019.05.012. Epub 2019 May 31. PMID: 31160073.

        Adapt to evolving screening guidelines

        In the post-vaccination era the prevalence of high-risk genotypes is changing making it crucial to identify high-risk genotypes individually9

        The BD Onclarity™ HPV assay is FDA-approved for extended genotyping, offering the flexibility you need to adapt to changing clinical landscape and screening guidelines

        References

        1. World Health Organization, Department of Reproductive Health and Research. Cervical cancer, human papillomavirus (HPV), and HPV vaccines—key points for policy-makers and health professionals. 2007. 
        2. Oliver SE et al. J Infect Dis. 2017;216(5):594–603.  
        3. Drolet M et al. Lancet Infect Dis. 2015;15(5):565–580.  
        4. Garland SM et al. Clin Infect Dis. 2016;63(4):519–527. 
        5.  Stoler et al. Clin Infect Dis. 2019 ;153(2) :259-265.  
        6. Schiffman M et al. Gynecol Oncol. 2015;138(3):573–578.  
        7. Schiffman M et al. Int J Cancer. 2016;139(11):2606–2615.  
        8. BD Onclarity HPV Assay US Package Insert [8089894]  
        9. Osbourne et al. Vaccine. 33(2015)201-208.  
        10. Stoler MH et al. Gynecol Oncol. 2019;153(1):26–33.  
        11. Bonde J et al. Int J Cancer. 2019; doi:10.1002/ijc.32291.  
        12. Elfgren K et al. Am J Obstet Gynecol. 2017;216(3):264.e1–264.e7. 
        13.  Radley D et al. Hum Vaccin Immunother. 2016;12(3):768–772. 
        14. Bottari F et al. J Low Genit Tract Dis. 2019;23(1):39–42.  
        15. Perkins RB, Fuzzell LN, Lake P, McIntyre M, Nayar R, Saraiya M, Loukissas J, Felder T, Guido RS, Vadaparampil ST. Incorporating Stakeholder Feedback in Guidelines Development for the Management of Abnormal Cervical Cancer Screening Tests. J Low Genit Tract Dis. 2020 Apr;24(2):167-177. doi: 10.1097/LGT.0000000000000524. PMID: 32243312; PMCID: PMC7147423.  
        16. 16. Gage JC, Schiffman M, Katki HA, Castle PE, Fetterman B, Wentzensen N, Poitras NE, Lorey T, Cheung LC, Kinney WK. Reassurance against future risk of precancer and cancer conferred by a negative human papillomavirus test. J Natl Cancer Inst. 2014 Jul 18;106(8):dju153. doi: 10.1093/jnci/dju153. PMID: 25038467; PMCID: PMC4111283.  
        17. Wright TC Jr, Stoler MH, Parvu V, Yanson K, Cooper C, Andrews J. Risk detection for high-grade cervical disease using Onclarity HPV extended genotyping in women, ≥21 years of age, with ASC-US or LSIL cytology. Gynecol Oncol. 2019 Aug;154(2):360-367. doi: 10.1016/j.ygyno.2019.05.012. Epub 2019 May 31. PMID: 31160073.

         

        Advance HPV testing accuracy and make more informed decisions

        The BD Onclarity™ HPV assay is designed to minimize the risk of false-negative results by:

        • Including an internal cellular control, verifying that a sample is present8
        • Targeting the E6/E7 region of the HPV viral genome rather than the L1 region, which can be deleted during HPV DNA integration8
        • The BD Onclarity™ HPV assay is designed to minimize the risk of false-positive results by lacking cross-reactivity with low-risk HPV types8
        • The BD Onclarity™ HPV assay with extended genotyping enables you to stratify patients according to risk10
        • Make more informed decisions with the extended genotyping information you need to assess each patient’s risk for confident follow-up decisions10-14

        References

        1. World Health Organization, Department of Reproductive Health and Research. Cervical cancer, human papillomavirus (HPV), and HPV vaccines—key points for policy-makers and health professionals. 2007. 
        2. Oliver SE et al. J Infect Dis. 2017;216(5):594–603.  
        3. Drolet M et al. Lancet Infect Dis. 2015;15(5):565–580.  
        4. Garland SM et al. Clin Infect Dis. 2016;63(4):519–527. 
        5.  Stoler et al. Clin Infect Dis. 2019 ;153(2) :259-265.  
        6. Schiffman M et al. Gynecol Oncol. 2015;138(3):573–578.  
        7. Schiffman M et al. Int J Cancer. 2016;139(11):2606–2615.  
        8. BD Onclarity HPV Assay US Package Insert [8089894]  
        9. Osbourne et al. Vaccine. 33(2015)201-208.  
        10. Stoler MH et al. Gynecol Oncol. 2019;153(1):26–33.  
        11. Bonde J et al. Int J Cancer. 2019; doi:10.1002/ijc.32291.  
        12. Elfgren K et al. Am J Obstet Gynecol. 2017;216(3):264.e1–264.e7. 
        13.  Radley D et al. Hum Vaccin Immunother. 2016;12(3):768–772. 
        14. Bottari F et al. J Low Genit Tract Dis. 2019;23(1):39–42.  
        15. Perkins RB, Fuzzell LN, Lake P, McIntyre M, Nayar R, Saraiya M, Loukissas J, Felder T, Guido RS, Vadaparampil ST. Incorporating Stakeholder Feedback in Guidelines Development for the Management of Abnormal Cervical Cancer Screening Tests. J Low Genit Tract Dis. 2020 Apr;24(2):167-177. doi: 10.1097/LGT.0000000000000524. PMID: 32243312; PMCID: PMC7147423.  
        16. 16. Gage JC, Schiffman M, Katki HA, Castle PE, Fetterman B, Wentzensen N, Poitras NE, Lorey T, Cheung LC, Kinney WK. Reassurance against future risk of precancer and cancer conferred by a negative human papillomavirus test. J Natl Cancer Inst. 2014 Jul 18;106(8):dju153. doi: 10.1093/jnci/dju153. PMID: 25038467; PMCID: PMC4111283.  
        17. Wright TC Jr, Stoler MH, Parvu V, Yanson K, Cooper C, Andrews J. Risk detection for high-grade cervical disease using Onclarity HPV extended genotyping in women, ≥21 years of age, with ASC-US or LSIL cytology. Gynecol Oncol. 2019 Aug;154(2):360-367. doi: 10.1016/j.ygyno.2019.05.012. Epub 2019 May 31. PMID: 31160073.

         

        ASSAYS

        BD SurePath™ Liquid-based Pap Test

        Learn more about the BD SurePath™ collection vial and the BD SurePath™ Liquid-based Pap Test

        Offering accuracy from collection to result

        The BD SurePath™ Liquid-based Pap Test is your trusted partner for reliable sample collection and accurate result reporting

        • The BD SurePath™ collection vial is designed to improve patient care over conventional pap by providing physicians with the convenience of a single-source collection Pap screening and molecular diagnostic testing
        • The BD SurePath™ Liquid-based Pap Test and the BD Onclarity™ HPV Assay provide HPV primary screening, co-testing and cytology primary with ASCUS reflex
        • When used with the BD Totalys™ MultiProcessor, the BD SurePath™ collection vial 2D barcodes allow Positive Sample Identification from collection through cytological and molecular testing, providing confidence in the results
        • The BD SurePath™ Liquid-based Pap Test can be processed according to the throughput and the automation levels needed. BD Totalys™ MultiProcessor or BD PrepMate™ (sample preparation, including cell enrichment), BD Totalys™ SlidePrep (slide preparation and staining) and BD FocalPoint™ GS Imaging System (slide analysis)

         

        References

        * Results from a comprehensive, independent study representing nearly 6 million samples from over 13 years of data taken from a national screening program4

        ASCUS, atypical squamous cells of undetermined significance; HSIL, high grade squamous intraepithelial lesions

        1. Moriarty AT et al. Arch Patho Lab Med. 2009;133(12):1912–1916.  
        2. Fontaine D et al. BMJ Open. 2012;2(2):e000847.  
        3. Fremont-Smith M et al. Cancer. 2004; 102(5):269–279.  
        4. Rozemeijer K et al. BMJ. 2017;356:j504.  
        5. Bigras G et al. J Low Genit Tract Dis. 2003;7(3):168–174.  
        6. Nance KV. Diagn Cytopathol. 2007;35(3):148–153.  
        7. Sweeney B et al. Cancer. 2006 ;108(1) :27-31

        Standardize and simplify your medication management process

        Your medication management solution should be a reliable source for the information and medications needed as patient conditions evolve. Our solutions standardize and simplify your medication management process, reducing the risk for error and inefficiency. BD connected technologies work together with your EMR to provide added safety for your patients and confidence for your clinicians.

        Beyond the EHR:  Best Practices in Enterprise Medication Management

        Streamline operations with actionable insights

        Delivering industry-leading patient care doesn’t need to strain financial resources and put undue pressure on your staff. Connected Medication Management brings together disparate systems so you can achieve a consistent view across your sites of care. You can free your staff to get back to working at the top of their licenses, allowing them to focus on what matters most—delivering outstanding patient care.

        Increased connectivity means bigger gains in process efficiencies

        Unite disparate systems and gain visibility

        When your data is scattered, your operations can be too. Connected Medication Management leverages your EMR to create a comprehensive view of inventory on hand. That means managing fewer databases and gaining visibility so you can make valuable impacts on workflows across your organization and minimize medication diversion and adverse drug events. By having connected systems and bidirectional data exchange, predictive analytics can inform critical decision-making about care needs, help control carrying costs and avoid wasted inventory.

        Webinar: From big data to results: Accelerating and sustaining medication inventory optimization

        Leveraging IT investments with BD Connected Medication Management Solutions

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              Evolving methods, one goal: the prevention of cervical cancer