Delphi Screener

Self-sampling with the Delphi Screener further increases participation in the Finnish Cervical Cancer Screening Program

Martine — Thu, 06 Jun 2013 19:07:03 +0000

In 2011 researchers of the Mass Screening Registry at the Finnish Cancer Registry started a study among non-attendees of the cervical screening program in urban, semi-urban and rural areas of the country. Earlier, a successful pilot study in the urban municipality Espoo had shown that the Delphi Screener was a feasible option in enhancing attendance to the cervical cancer screening program*. In this new study non-attendees of the screening program residing in 22 municipalities receive a reminder letter. Women not responding to the reminder letter are offered the Delphi Screener. Anni Virtanen et al. recently submitted a manuscript to a Finnish medical journal ”Duodecim” with interim results. These first results confirm that self-sampling with the Delphi Screener improves screening attendance, particularly when used in addition to a reminder letter. Offering self-sampling to this group of women provides the opportunity to further improve the outstanding Finnish screening program. The Hybric Capture 2 high risk type Human Papilloma Virus DNA screening test of Qiagen is used as a validated test for the Delphi Screener.

* Self-sampling versus reminder letter: effects on cervical cancer screening attendance and coverage in Finland. Anni Virtanen et al – International Journal of Cancer 2011, 128 (11); 2681–2687.
Self-sample HPV test as an intervention for nonattendees of cervical cancer screening in Finland: a randomized trial.Anni Virtanen et al – Cancer Epidemiol Biomarkers Prev 2011, 20(9):1960-1969.

Robert Koch-Institute researchers presented results self-sampling study

Martine — Tue, 21 May 2013 09:24:08 +0000

Researchers from the Robert Koch-Institute, in cooperation with the Charité University clinic in Berlin, have presented additional results of the self-sampling study with the Delphi Screener amongst German women between the age of 20 and 25. At the ECCMID (European Congress of Clinical Microbiology and Infectious Diseases) 2013 in Berlin, Yvonne Deleré and Cornelis Remschmidt presented two posters. One poster discussed the risk factors of Human Papilloma Virus (HPV) infections for young women. The other poster reported HPV prevalence. The outcome of the analysis confirms the validity of the samples obtained with the Delphi Screener in the field of cervical cancer screening.

Earlier results of the pilot study have been published in 2011 by Dr. Deleré et al (Cervicovaginal Self-Sampling Is a Reliable Method for Determination of Prevalence of Human Papillomavirus Genotypes in Women Aged 20 to 30 Years (J. Clin. Microbiol. 2011, 49(10):3519)).

Thai Authorities launch dedicated website for cervical cancer screening with the Delphi Screener

Martine — Mon, 15 Apr 2013 08:23:04 +0000

On January 15, 2013, the novel cervical cancer screening method Delphi Screener was launched in Thailand. Thai authorities recognized the importance of the Delphi Screener as an additional way to provide screening for cervical cancer in a reliable and trusted way, especially for Thai women who do not regularly take Pap smears. Thai authorities recently launched a dedicated website to provide more information about the Delphi Screener to women: www.delphithai.com. Also, several broadcast channels discussed this new offering for doctors and patients extensively in television shows.

The Delphi Screener is a non-invasive, a-traumatic instrument with a unique lavage technique to collect cervico-vaginal specimen. The samples can be collected either by doctors or by women themselves (self-sampling). The samples are tested in the laboratory with the validated high risk Human Papilloma Virus DiAssay test (HPV).

For questions you can contact:

Delphi Bioscience (Netherlands)
Marlisa Meijerink
mm@delphi-bioscience.com

Cancer Society of the Ardennes includes Delphi Screener self-sampling method in French CervicalCancer screening pilot study

Martine — Fri, 22 Mar 2013 12:18:05 +0000

The National Cancer Institute in France (INCa) has asked the Cancer Society of the Ardennes Region (SAC08) to initiate a pilot study for population based cervical cancer screening. In this study, the Delphi Screener will be used as self-sampling method.

The SAC08 (Dr. E Rousselot-Marche and Mrs. B Charlier), CHU Reims (Pr. C Clavel and Dr. V Dalstein), Réseau ONCOCHA, pathologists, gynecologists and the general practitioners cooperate to start the population based trial in which the introduction of an invitation-based screening program will be evaluated.

Fifty thousand women between 25 and 65 years old who have not had a Pap smear in the past 3 years, will receive a letter inviting them to visit their general practitioner or gynecologist for a smear. Women who do not respond to this invitation will receive a second invitation after 4 months. A third invitation will be sent after 8 months to women who still do not respond, in which self-sampling is offered with the Delphi Screener.

Previous trials in several countries have shown that many women do not respond to an invitation for a smear at the clinic due to barriers like embarrassment, culture, lack of time and fear. The Delphi Screener can take away these barriers, resulting in an increase of the screening coverage.

In this trial the Hybrid Capture 2 assay of Qiagen will be used for HPV testing. The goal of the study is to evaluate in a general population, the feasibility of primary HPV testing with cytological triage in women 31-65 years. Evaluation of responses to the invitations, follow-up management, large screening intervals (5 years) for women with a negative HPV test and ownership of HPV testing by the physicians and women will be also analyzed. The study started in May 2012 and is expected to run for the next 2 years. The population studied is refractory to screening, offering the Delphi Screener method to women aims to increase participation to cervical cancer screening in this population.

The Delphi Screener is the most widely validated primary cervical cancer screening method besides the traditional Pap smear. Screening is based on the unique lavage-based, soft, a-traumatic sampling method and a validated high risk Human Papilloma Virus test for this sampling platform. The Delphi Screener is more sensitive to detect women at risk than traditional Pap smear and as reliable as an HPV-test on a doctor’s collected sample.

Delphi Screener used in unique high-risk HPV prevalence study amongst pregnant women in Ethiopia

Martine — Tue, 29 Jan 2013 12:49:59 +0000

Ethiopia is facing high numbers of cervical cancer, caused by the high risk HPV (hrHPV). A better understanding of the burden of the virus types provides the opportunity to work on vaccination and screening initiatives. To obtain insight in the prevalence of hrHPV in women, a unique study on cervical cancer will be conducted amongst pregnant Ethiopian women in 2013. The Delphi Screener will be used to collect lavage samples from pregnant women.

Five years ago, a strong collaboration platform on gynecological cancer has been established between the Department of Gynecology (Dr. Kantelhardt and Prof. Thomssen) and Clinical Epidemiology (Prof. Stang) of the Martin Luther University, Halle (Saale), Germany and the School of Public Health (Dr. Adamu) and Radiotherapy Center (Dr. Mathewos) at Addis Abeba University, Ethiopia. The international Women´s Health working group from the German Society of Obstetrics and Gynecology (DGGG) is also involved.

The study team will collect 500 specimens of women between the age of 20 and 40 for high risk HPV testing. Women from different ethical backgrounds and from across the whole country will be invited. In Ethiopia women do not frequently visit the health care system. Therefore the team decided to focus on pregnant women as most of them do visit a health care worker once during pregnancy. During this visit the women will be asked to take a vaginal-cervical specimen by herself under supervision of a study team member from Germany. The specimens will be tested by the Deutsche Krebsforschungszentrum (German Cancer Research Institute DKFZ) in Heidelberg, Germany. The team of Markus Schmitt, under supervision of Dr. Michael Pawlita, has a high reputation in molecular testing.

Traditional sampling techniques like brushes and swabs, do actually scrape the vaginal wall and may cause lesions or induce labor. The Delphi Screener is a smooth, a-traumatic lavage sampling method. The Delphi Screener is reliable, user friendly and atraumatic, reasons for the study team to use the Delphi Screener in pregnant women.

The Delphi Screener is prefilled with a small amount (teaspoon) of saline, which is released into the cervix area and then returns inside the device with a high yield of cells. The Delphi Screener has been used by more then 30.000 women in clinical studies and has shown to collect reliable specimens in the field of hrHPV testing¹. Either a doctor or the woman herself (self-sampling) can use the Screener to collect a specimen.

January 2013

¹ Deleré Y et al. Cervicovaginal self-sampling is a reliable method for determination of prevalence of human papillomavirus genotypes in women aged 20 to 30 years; J Clin Microbiol. 2011 Oct;49(10):3519-22. doi: 10.1128/JCM.01026-11. Epub 2011 Aug 3

Thailand-Dutch collaboration launches unique self-Screening device to boost cervical cancer screening

Martine — Tue, 15 Jan 2013 13:40:32 +0000

On March 26 the launch of the Delphi Screener in Thailand has been taken place.
- Use-at-home Delphi Screener targets one-third of women in Thailand who are averse to Pap Smear
- Cervical cancer still leading cause of death at Thai women aged 25-65 years old
- Delphi Screener launch in Thailand leads roll-out to developing countries in Asia where rate of cervical cancer screening is low and incidence is high

Bangkok January 15, 2013 – For the first time, women in Thailand who are averse to Pap smear will be able to self-screen against cervical cancer in the privacy of their own homes. The Delphi Screener could reduce the chances of cancer as women would be able to conduct the test regularly.

During the launch symposium held in Bangkok, associated Professor Doctor Wichai Termrungruanglert (M.D.), head of Gynecologic Oncology Division at the Chulalongkorn University in Bangkok, shared with the audience that cervical cancer was responsible for the highest number of cancer-related deaths among Thai women. In Thailand there are approximately 10.000 new cases of cervical cancer per year with a death rate of 5.000 cases/year (50%), which means 14 deaths per day. Women at risk refrain from screening at clinics or hospitals because of shyness and concerns about pain with the Pap test .

With the Delphi Screener these constraints are taken away. The Delphi Screener allows for a completely new way of obtaining a cervical sample. The woman herself can take a sample with the Delphi Screener in an a-traumatic way by using a soft lavage technique. The Delphi Screener can be easily inserted into the vagina by the user to the top of the cervix to collect cervical and vaginal cells with a sterile, saline liquid. This specimen is then sent to an authorized laboratory for testing for high-risk Human Papilloma Virus (hrHPV) with a clinically validated highly sensitive DNA-test. In contrast to the Delphi Screener method, a Pap smear test uses cells that are scraped from the cervix, stained and then examined under a microscope for changes or abnormalities, a process known as a cytology test. This test however is much less sensitive for detecting signs of cervical cancer.

Worldwide, cervical cancer is the third most common type of cancer among women, according to the World Health Organisation. Although Thailand has launched many programs to prevent and screen for cervical cancer, a huge number of Thai women still cannot gain access to the screening due to certain restrictions. The Delphi Screener overcomes these restrictions.

Head of the HPV Research Group at the VU University Medical Center, Amsterdam, The Netherlands, Professor Chris Meijer, said: “Studies that we have conducted, as well as studies by other leading research groups have shown that HPV tests can result in earlier detection of clinically relevant pre-cancerous lesions compared to cytology tests. This means that more cervical cancers can be prevented.”

Prof. Meijer is one of Europe’s leading pathologists with a special interest in the relationship between HPV and cervical cancer.

He added: “In Europe, we have found that sending home testing kits to target women who do not participate in the cervical cancer screening program, resulted in twice as many cases of cervical cancer being diagnosed compared with the regular screening program.”

The Delphi Screener is being brought into Thailand by Delphi Bioscience Asia Pte

Ltd, a joint-venture between Dr Tay, gynecological oncologist in Singapore and his partners, and Delphi Bioscience BV of the Netherlands.

For more information, please refer to www.delphiscreener.asia.

For media queries, please contact:
Ms Art Medical Support in Bangkok

+66 2 158 9707 or +66 2 158 9522

Press Releases Launch Delphi Screener Thailand

Martine — Tue, 15 Jan 2013 09:06:27 +0000

On January 15 the launch of the Delphi Screener inThailand has been taken place.

Please find more information in the press releases below.

http://www.thaipr.net/health/454023 or http://www.thaipost.net/x-cite/170113/68168

Delphi Screener highly rated by women during acceptance study in Rwanda

The Church — Thu, 23 Aug 2012 11:42:12 +0000

Delphi Bioscience partnered with a network of European and African university scientists in a study entitled: “Characterization of novel microbicide safety biomarkers in East and South Africa”. The Delphi Screener, an innovative medical device to collect vaginal samples, was made available for use within this study. A total of 60 Rwandan women used the Screener on two different occasions. The study demonstrated that the Delphi Screener is highly appreciated by women to collect vaginal samples themselves. The results of the study were recently presented in Sydney, Australia, at the Microbicides 2012 conference.

Dr. Janneke van de Wijgert, Associate Professor at the Academic Medical Centre of the University of Amsterdam, explains: “We have recruited women who are regularly tested for vaginal infections to participate in the study. It was the first time that the Delphi Screener was introduced to these women to enable them to take vaginal samples themselves. As the women had never done this before, they obviously felt unaccustomed to the process and had to get used to it. The results of the study show that the women are more then willing to practice self-testing. Moreover, the women find the Delphi Screener easy to use.”

The participants were also asked whether they prefer a system of self-sampling to having the traditional cervical smear taken with a speculum. A large majority of the women indicated that they prefer using the Delphi Screener. With that, the Delphi Screener seems to be the perfect, female friendly alternative for both doctors and women to take samples.

Dr Maarten Wiegerinck, Chief Scientific Officer at Delphi Bioscience, is enthusiastic about the results and the fact that women in Africa are positive about the convenience offered by the Delphi Screener. Dr. Wiegerinck:

“The results in Rwanda coincide with the excellent results obtained through acceptance studies conducted for the Delphi Screener in the Netherlands, Germany, Singapore and the US”

For questions concerning this press release please contact:

Marlisa Meijerink, Delphi Bioscience,

by e-mail: mm@delphi-bioscience.com

or by telephone: +31(0)6-52386460

Detlef-Petzoldt-price with a study among German women with the Delphi Screener

Martine — Tue, 05 Jun 2012 13:23:29 +0000

German Robert Koch-Institut’s Dr. Yvonne Deleré has won the recognized Detlef-Petzoldt-price with a study among German women with the Delphi Screener. The prevalence of high risk Human Papilloma Virus in women between 20 and 25 years old has been investigated.”

For more information http://dstig.de/index.php/aktuellespressekalender/87-and-the-winners-are

Delphi Screener successfully applied in clinical study

The Church — Tue, 29 May 2012 04:13:12 +0000

The Delphi Screener was successfully applied during a major clinical study conducted among 27,792 women. It appeared from the study that 30% of all women who do not have cervical smears taken by their doctors are willing to participate in tracing the human Papillomavirus (HPV) by means of home testing. HPV home testing is a highly effective means of detecting (precursory) cervical cancer.

Women who had never taken part in a medical population examination did however choose to do the home test. These women indicated that convenience and privacy in particular were the reasons why they were willing to try home testing.
The participation of these women is specifically important due to the fact that they are three times more susceptible to cervical cancer than women taking part in medical popular examinations.

Women in the age group of 30-60 are called on once every five years to have a cervical smear taken by the doctor within the framework of medical population examination for cervical cancer (BVO BMHK). Only 67% of all women actually respond to these calls to participate. Approximately 630 women are diagnosed with cervical cancer each year, of whom approximately 230 succumb to the disease. Half of these cancer cases occur among women who do not participate in the medical population examination.

Murat Gök has studied the possibilities of increasing participation in the BVO BMHK by offering home testing. Gök concludes that HPV home testing can reduce the number of cases of cervical cancer and that home testing can also improve the effectiveness of cervical cancer research.

The results of his research have been published in the March 2010 edition of the British Medical Journal.

Murat Gök obtained his doctorate at the VU Medical Centre on May 15 last.

For questions concerning this press release please contact:

Marlisa Meijerink, Delphi Bioscience,
by e-mail: mm@delphi-bioscience.com
or by telephone: +31(0)6-52386460