Incidence and mortality of gynecological cancers


Despite the many recent advances in cancer diagnosis and treatment, gynecological cancers are responsible for approximately 25.000 deaths per year and are the third leading cause of cancer-related mortality in women in the United States 1. Most of the deaths are caused by tumors that metastasize prior to the onset of symptoms, in part because there are no accurate screening methods for these cancers and they are often diagnosed at a late stage.


Worldwide, more than 200.000 deaths per year from gynecological cancers are expected 2,3.

The high mortality associated with undetected gynecologic malignancies has made the development of an effective screening tool a high priority.

More then 22.000 women with a positive diagnosis in the U.S.1
More then 14.000 deaths each year 1




ovarian cancer

Ovarian cancer is less common but more lethal. It is often diagnosed at a late stage, when the 5-year survival rate is less than 30%.

Ovarian and endometrium cancer
More then 62.000 new cases diagnosed in the U.S. each year 1
More then 11.000 women die each year from the disease 1


endometrium cancer

Endometrial cancer is the most common gynecologic malignancy.


1) Howlader et al. SEER Cancer Statistics Review, 1975–2014 (National Cancer Institute, 2017).
2) Bray et al.. Int. J. Cancer 10.1002/ijc.27711 (2012).
3) International Agency for Research on Cancer, GLOBOCAN 2008 v1.2, Cancer Incidence and Mortality Worldwide: IARC CancerBase
No. 10; http://globocan.iarc.fr.


A Pap-Based DNA Test for Early Detection of Endometrial and Ovarian Cancers

Cervical fluid samples gathered during routine Pap tests are the basis of a revolutionary screening test for gynecological cancers

Prevention and early detection remain essential to decreasing cancer mortality. For many years, researchers have strived to develop a feasible and reliable way to detect early-stage gynecological cancers.

The introduction of routine screening for cervical cancer with cytology (the Papanicolaou test, otherwise known as “Pap smear”) has dramatically decreased the incidence and mortality of cervical cancer in the screened population, by permitting the detection of early-stage, surgically curable cervical tumors and their precursors

Physician brochure


Unfortunately, the identification of malignant cells from endometrial and ovarian carcinomas in cervical cytology specimens is relatively uncommon. Microscopic examination cannot always distinguish them from cervical carcinomas, or from more benign conditions.


Screening DNA in Pap smears has the potential to increase the rate of early-stage detection of endometrial and ovarian cancers in women who do not have any symptoms. This DNA could be exploited to detect somatic mutations in tumor DNA released from endometrial and ovarian cancers shed cells accumulating in the cervix.

How the test works

A Groundbreaking technology allowing for a genetic analysis that is revolutionary


Sampling Procedure

Simple and fast procedure


Cancer cells are sampled during routine Pap tests with a brush (a “Pap brush”) that is inserted into the endocervical canal to scrape the surface of the cervix and then rinsed in a liquid-filled vial containing preservative fluid.

For the detection of cervical cancers, cells from the fluid are applied to a slide for cytologic examination (the classic Pap smear). From the remaining sample, somatic mutations could be detected in tumor DNA of women with ovarian or endometrial, ovarian and cervical cancers.
PAPNext Sampling Procedure

Indications

PAPNext test is meant for preventative surveillance of highrisk populations.
It may be beneficial for (but not limited to):

Genetic predisposition
Genetic predisposition

Patients with inherited predisposition to ovarian cancer, such as those with germline mutations in BRCA1 or BRCA2 gene or those with Lynch syndrome, caused by a germline mutation in MSH2 or MLH1 genes.

Risk factors
Risk factors

Patients who are at high risk for gynecologic cancers, e.g. because of hereditary factors, obesity, or symptoms such as postmenopausal or dysfunctional uterine bleeding.

Positive screen
Positive screen

Patients with positive conventional cytology screening test results.

Family History
Family History

Patients with a significant family history of endometrial and ovarian cancer.

Fattori di rischio
Early detection

Any patient wishing to undergo to preventative surveillance for endometrial, ovarian and cervical cancers.

Benefits

A new dimension of screening for gynecologic cancers

Early detection of endometrial and ovarian cancers based on genetic analyses of DNA recovered from the fluids obtained during a routine Papanicolaou (Pap) test



PAPNext is a screening test that identifies cancer-related alterations in DNA obtained from cervical fluids gathered during a routine Pap test

PAPNext test can detect endometrial and ovarian cancers at their early stage. Earlier detection of cancer could lead to earlier treatment and potentially better outcomes for patients.

PAPNext test leverages the existing cervical screening strategy with an advanced sequencing technology to assess for DNA mutations in 30 genes that are commonly mutated in endometrial, ovarian and cervical cancers, providing a cost-effective screening approach for these gynaecologic malignancies.

PapNext

Science behind the test


A recent study4 demonstrated the ability to detect endometrial and ovarian cancer based on genetic analysis of DNA recovered from cervical fluids obtained during a routine Papanicolaou (Pap) test. When an advanced sequencing technology was used to screen Pap test samples, gathered from women endometrial and ovarian cancer, for somatic mutations in DNA, the assay identified cancer-related alterations.

sensibilità tecniche sequenziamento

In addition, no cancer-related alterations were detected in samples collected from bwomen without cancer, yielding a very high specificity (>99.9%)5.

4) Kinde et alSci Transl Med. 2013 Jan 9;5(167):167ra45)
5) Wang et al. Sci Transl Med. 2018 Mar 21;10(433). pii: eaap8793.

Methodology

In-depth analysis of genes with advanced technology

PAPNext test is performed using highly advances Next Generation Sequencing (NGS) technology to screen for tumor DNA mutation in 30 genes that are commonly mutated in endometrial and ovarian cancers.

The technology is based on full exon sequences, at high sequence dept, of all genes included in the panel, which allow a more comprehensive analysis of each gene investigated.


Next Generation Sequencing (NGS)

Advanced bioinformatic analysis for variant interpretation to deliver the greater accuracy.

Analysis of NGS data is a complex process, imposing challenging requirements both in terms of computing resources and software.

PAPNext test uses powerful custom-built bioinformatics solutions to support variant analysis that enables fast, reliable and highly accurate results. When a variant is detected during the sequencing process, its pathogenicity will be investigated using a sophisticated software. A team of board-certified geneticists provide expert interpretation and clearly explained reports.

Endometriome



advanced molecular diagnostics solutions in reproductive genetics using state-of-the art technologies

Test performed in Italy
(Rome or Milan)

Fast TAT:
10 days

20 years
experience

Personalized genetic counseling

Laboratories ISO 17025 accredited

Test available
worldwide

Over 200.000
genetic tests/year.

Dedicated R&D team

Results

Understanding PAPNext™ results
POSITIVE RESULT

POSITIVE RESULT

This result shows that the test identified clinically relevant somatic mutation(s) in tumor DNA, in one or more of the targeted genes screened. A patient with a positive test result should be referred for genetic counselling before any medical decisions are made.

Consulenza geneticaGenetic counselling
Genetic counselling is essential for any patient. Genoma will provide a genetic counselling session for those patients that screen positive, and the service is included in the cost of the test. It aids the patients in medical comprehension and enhances patient satisfaction by providing access to experts who are skilled at explaining genetics risk in terms patients can understand.

NEGATIVE RESULT

NEGATIVE RESULT

This result shows the test has not detected any clinical relevant mutation in the targeted genes screened. A single test cannot always detect all possible genetic changes that cause a particolar cancer condition, hence a negative results do not completely rule out the presence of malignancies screened.


PAPNext Technical Report
PAPNext

5 easy STEPS

Order PAPNext shipping kit

Fill in all requires TRF information

Collect the sample using the Pap brush

Ship the sample to Genoma Lab

Receive results in as little as 10 days

CONTACT US

Information request for PAPNext test

Contact us by calling the Contact Center 06.164161500 (12 lines PBX) to discover how you can perform PAPNext test or fill out the form below. Your personal information will be used exclusively to satisfy your request, in the absolute respect of your privacy.

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ROME
Labs and Genetic Counselling
R&D Laboratory
Via Castel Giubileo, 11 - 00138 Rome
Diagnostic Lab and Genetic Counselling
Via Castel Giubileo, 62 - 00138 Rome (RM)
Contact Center: + (39) 06.164161500 (12 lines PBX)
Fax : +(39) 06.64492025

MILAN
Diagnostic Lab and Genetic Counselling
Via Enrico Cialdini, 16 (Affori Centre)
20161 Milan (MI)
Contact Center: + (39) 06.164161500 (12 lines PBX) (12 linee PBX)
Fax : + (39) 02 39297627

E-mail
info@laboratoriogenoma.eu

Website
http://www.laboratoriogenoma.eu

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