Self-screen BV

Self-screen BV is a Dutch molecular diagnostics company based in Amsterdam, The Netherlands, that describes itself as "the company for innovative screening and diagnostic assays." Its work is built on translational science: it converts molecular research findings on human papillomavirus (HPV) and DNA methylation into laboratory tests that can be used in cervical cancer screening programmes and in the follow-up of women who test HPV-positive. The company's commercial focus is cervical cancer prevention. Self-screen states that cervical cancer develops from a persistent HPV infection and is the fourth most common cancer in women, with an estimated 660,000 women diagnosed worldwide in 2022 and about 350,000 deaths that year. Its stated solution is a set of molecular tests that identify women at risk of cervical cancer and its precursor lesions, and that can distinguish women with progressing premalignant lesions or early-stage cancer who need treatment. Self-screen's product portfolio centres on two complementary molecular technologies. The HPV-Risk Assay is an in vitro real-time PCR test for the qualitative detection of HPV DNA, targeting the E7 region of 15 (probably) high-risk HPV genotypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 67 and 68. The QIAsure Methylation Test (also referred to as the PreCursor-M+/QIAsure Methylation Test) is a real-time PCR-based molecular assay that detects women with a cancer-like methylation profile who have a short-term high risk of progression to cervical cancer. The company also offers the PreCursor-M AnoGYN Methylation Assay (RUO), which identifies hypermethylation levels of two genes, and lists PreCursor-M Gold among its offerings. According to the company, combining the HPV-Risk Assay and the QIAsure Methylation Test makes full-molecular automated cervical screening possible, bringing together the objectivity, reproducibility and high-throughput characteristics of both assays. Self-screen presents itself as a science-driven diagnostics provider rather than a consumer brand. Its website includes sections on its science, its laboratory, its management team, publications and vacancies, and it maintains a body of peer-reviewed publications on FAM19A4/mir124-2 methylation analysis, including studies on long-term CIN3+ risk, self-sampling, hrHPV genotyping and intra- and inter-laboratory agreement of the methylation test. The company is headquartered in Amsterdam and operates in the clinical diagnostics and screening market, serving laboratories and screening organisations in the Netherlands and internationally.

Self-screen BV is a Dutch molecular diagnostics company headquartered in Amsterdam, The Netherlands. Public information about the company describes it as a company in Amsterdam, and its own website frames its history as "a track record of translational science" — that is, a history of moving discoveries from molecular research into practical screening and diagnostic assays. The scientific foundation of the company lies in research on human papillomavirus (HPV) and on DNA methylation markers as indicators of cervical cancer risk. Self-screen's website lists a substantial body of publications on FAM19A4/mir124-2 methylation analysis, including studies on the long-term CIN3+ risk of HPV-positive women after triage with FAM19A4/mir124-2 methylation analysis; comparisons of FAM19A4 methylation analysis in self-samples versus cervical scrapes for detecting cervical (pre)cancer in HPV-positive women; reliable identification of women with CIN3+ using hrHPV genotyping and methylation markers in a cytology-screened referral population; defining hrHPV genotypes in cervical intraepithelial neoplasia by laser capture microdissection to support reflex triage of self-samples using HPV16/18 and FAM19A4/mir124-2 methylation; intra- and inter-laboratory agreement of the FAM19A4/mir124-2 methylation test in an international study; cervical cancer risk in HPV-positive women after a negative FAM19A4/mir124-2 methylation test in a post hoc analysis of the POBASCAM trial with 14-year follow-up; and validation of the FAM19A4/mir124-2 DNA methylation test. This publication record indicates that the company's assays emerged from and remain tied to clinical research on molecular triage of HPV-positive women. Commercially, Self-screen has built its offering around two complementary molecular test families. The first is HPV testing: the HPV-Risk Assay, an in vitro real-time PCR-based assay for the qualitative detection of HPV DNA, targeting the E7 region of 15 (probably) high-risk HPV genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 67 and 68). The second is methylation-based triage: the QIAsure Methylation Test, a real-time PCR-based molecular assay that distinguishes women with cervical (pre)cancer by detecting a cancer-like methylation profile associated with a short-term high risk of progression to cervical cancer. The company also developed the PreCursor-M AnoGYN Methylation Assay (RUO), which identifies hypermethylation levels of two genes, and lists PreCursor-M Gold and methylated DNA among its offerings. A key strategic message on the company's website is that full-molecular automated cervical screening is now possible by combining the objectivity, reproducibility and high-throughput aspects of both the HPV-Risk Assay and the QIAsure Methylation Test. This positions Self-screen within the broader shift of cervical screening programmes from cytology toward molecular testing, in which HPV testing is used as a primary screen and methylation markers are used to triage HPV-positive women and reduce unnecessary referrals and overtreatment. The company's stated motivation is the burden of cervical cancer: it notes that every year over 350,000 women worldwide die unnecessarily from cervical cancer, that the disease develops from a persistent HPV infection, that it is the fourth most common cancer in women, and that in 2022 an estimated 660,000 women were diagnosed and about 350,000 died. Self-screen argues that cervical cancer can be effectively prevented by prophylactic HPV vaccination and cervical screening, and that early-detected cervical cancer is one of the most successfully treatable forms of cancer. Its assays are presented as tools to identify women at risk for cervical cancer and its precursor lesions, and to identify women with progressing premalignant lesions or early-stage cancer who need treatment. Self-screen operates as a private company based in Amsterdam, serving the clinical diagnostics and screening market. Its website provides sections on its company, what it does, what it offers, its laboratory, its team, vacancies, contact details, its science, its products and offering, and news, indicating an active commercial organisation with in-house laboratory capabilities and ongoing scientific communication. Specific founding dates, ownership structure and financial details are not provided in the available evidence.

Science-driven molecular diagnostics provider offering best-in-class HPV screening and methylation-based triage assays for cervical cancer prevention.

• HPV-Risk Assay

  In vitro real-time PCR-based assay for the qualitative detection of HPV DNA, targeting the E7 region of 15 (probably) high-risk HPV genotypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 67 and 68.

• QIAsure Methylation Test (PreCursor-M+/QIAsure Methylation Test)

  Real-time PCR-based molecular assay to distinguish women with cervical (pre)cancer; specifically detects women with a cancer-like methylation profile who have a short-term high risk for progression to cervical cancer.

• PreCursor-M AnoGYN Methylation Assay (RUO)

  Methylation assay developed by Self-screen that identifies the hypermethylation levels of two genes; offered for research use only (RUO).

• PreCursor-M Gold

  Listed among Self-screen's products and offering.

• Methylated DNA

  Listed among Self-screen's products and offering.

1. 1Home - Self-screenself-screen.nl
2. 2Our company – Self-Screenself-screen.nl
3. 3Discover our products - Self-screenself-screen.nl
4. 4Self-screen BV (Netherlands) - Wikidatawikidata.org