Step USA

What has to be considered if you want to start as a German biotech company on the American market? What are the legal bases and challenges there? We got an insight at the “Step USA Virtual” from June 28th until July 1st, 2021.

The four-day startup boot camp took place in New York and, due to Corona, virtually for us. Step USA was launched in 2014 by the German American Chamber of Commerce New York (GACC NY) and is organised together with the Frankfurt Main Chamber of Industry and Commerce, the TechQuartier, the Hessian Ministry of Economics, Energy, Transport and Housing, the Start Hub Hessen, the Stiftung für Technologie, Innovation und Forschung Thüringen (STIFT) and the holding company of Thuringia, bm|t. Around 40 German companies from various sectors took part, 12 of them from Thuringia. In addition to Dynamic42 GmbH, c-LEcta GmbH and others, we were among the companies selected from the bm|t portfolio.

Business culture, legal situation, immigration: How does it work in the USA?

As part of this intensive program, we got to know numerous American industry experts, mentors and investors. They advised us on US business culture, corporate marketing, raising capital, and immigration policies. The legal and tax issues were particularly interesting for us, because they form the basis for our planned market entry.

In addition to theoretical workshops, we were trained in storytelling. The business language in Germany sometimes differs greatly from the American one. Considering investor pitches in particular, it is important to know how to communicate business models convincingly in the respective culture.

A special highlight was the session with Susan Lindner on the subject of “Powerful Messaging & Storytelling”. Susan explained in an interactive way that representation plays an important role in sales. Above all, the advantages for the buyer should be emphasised more than the advantages of one’s own product.

Our personal conclusion

The four days were very informative and we learned a lot about the American corporate culture, especially for our industry! We would like to thank Andrea Diewald and Irene Fuchs from the German-American Chamber of Commerce for organising this great program.

Nevertheless, of course, a digital trip does not replace the on-site event: In autumn, the Step USA program will take place in New York again – we hope we then can be there in reality.

 

Since the beginning of 2020, when early cervical cancer screening in Germany was supplemented by a routine HPV test for women over 35, more people have been confronted with a positive test result. First, it is important to mention: This is not a reason to panic. A positive HPV test result is not to be equated with a precancerous stage or even cancer. Rather, most sexually active people become infected with human papillomavirus (HPV) at least once in a lifetime. In 90 percent of all cases, the infections heal on their own. If an HPV test is positive, this does not directly require a complex treatment. At first, only the control rhythm changes: Instead of three years, another HPV smear is carried out after twelve months. The first thing to do is to keep calm. (We’ll discuss how to get certainty quickly at the end of the blog post).

What does HPV positive mean?

A positive HPV test indicates a clinically relevant HPV infection on the cervix. This is associated with an increased risk of developing a tissue modification. These changes develop very slowly and over the years. A one-time positive HPV test therefore says nothing about cancer – it only detects a virus infection1.

If a renewed HPV smear is also positive after one year, a so-called colposcopy follows within three months. A special magnifying glass is used to clarify whether there are any changes in the tissue2.

In around ten percent of those infected, the body cannot successfully fight HPV on its own. Accordingly, tissue changes may develop that correspond to precursors of cervical cancer or may develop in the course of cancer3. In numbers, in Germany this applies to 4,500 people out of up to 500,000 who receive a conspicuous test result every year. It is therefore important to take precautions.

Differentiation between high and low risk HPV types

Over 200 different HPV types are now known. Cervical cancer or genital warts are caused by around 40 HPV types. They are divided into two categories4:

  • The low-risk types can cause bothersome and recurring genital warts. These can be treated well with various treatment options (e.g. ointments, icing, laser therapy).
  • If one of the high-risk types is detected, regular follow-up checks for cell changes are essential. The high-risk HPV types can lead to cancer, especially on the cervix. In addition, they are a possible trigger for head-and-neck tumors.

In general, it should be noted that an HPV infection itself cannot be treated. However, the respective effects should be kept in mind and tissue changes should be treated.

HPV: Partnership not necessarily affected

The initial diagnosis of an HPV infection as part of the new preventive care system often raises questions. Since regular tests for HPV in men are not currently planned, infections are primarily detected by cancer screening in women. It is important to know that the infection may have been present for many years or decades. No test procedure can answer the question of when an infection occurred. It also plays no role in the course of the normally harmless infection. The question of who infected whom in a partnership is also difficult to clarify. This is because the virus is widespread in the population as a whole. Accordingly, HPV might be noticed despite a firm partnership.

In new partnerships, the risk of infection can be reduced, for example, by using condoms during sexual intercourse. Another preventive measure is to be vaccinated against various cancer-causing HPV types5.

Quick certainty through GynTect

Of course, the waiting time between the check-ups can be stressful. A study co-authored by our managing directors Dr. Alfred Hansel and Dr. Martina Schmitz showed that the psychological stress involved in cervical cancer screening can even lead to signs of post-traumatic stress disorder6.

In order to resolve these unclear situations as quickly as possible, we have developed GynTect. The molecular biological cervical cancer test is able to detect cancer in its preliminary stages. A smear at the gynecologist is sufficient for the test.

 

[1] Projektgruppe ZERVITA (Hrsg.): HPV-Test.

[2] Deutsches Krebsforschungszentrum (DKFZ) (2021): HPV-positiv: Was nun?

[3] bis [5] Dr. med. Katharina Anstett (2020): HPV-Nachweis (Positive Testung auf ein Humanes Papillomavirus).

[6] Jentschke, M., Lehmann, R., Drews, N., Hansel, A., Schmitz, M., Hillemanns, P. (2020): Psychological distress in cervical cancer screening: results from a German online survey. Archives of Gynecology and Obstetrics, 3/2020, 699-705.

 

Picture: Image Point Fr / Shutterstock.com

At the beginning of May, things were turbulent, because we moved into our new offices and laboratories. The new location in a business park in Jena enables us to create more opportunities for our company growth and to increase our (international) sales.

Neue Büroräume von oncgnostics

It was the first time we’ve moved since the company was founded in 2012. Now, we have more space for our steadily growing team. This would not have been possible in the previous premises of the Bio-Instrumentation center (Bio-Instrumentezentrum BIZ) Jena.

We also needed better laboratory conditions to make research and production more efficient. Now we can better manage the increasing international interest in GynTect, which is reflected e.g. in the cooperation with Euroimmun and the cooperation with our Chinese partners, GeneoDx. With 352m², our new location is twice as large as the area in the BIZ. With two spacious offices and a conference room, nobody has to sit close to loud devices in the laboratory.

Extended laboratories and new break areas

Particularly practical is the new division of our laboratories. In particular, we can now coordinate the areas of responsibility even better thanks to an additional, fourth laboratory. While the laboratories for research & development and for PCR testing are located on the second floor, like our offices, the laboratories for our production are in the basement. The daily sports unit is thus integrated into everyday work. Now we finally have more space for our laboratory equipment and further developments and projects.

Neuer Aufenthaltsraum mit Blick auf den JenTower

In general, the rooms have felt homely after just a few days, also thanks to the smell of fresh paint and the new furniture. The cozy lounge has immediately become our new favorite place. Here we take a relaxed break together and can also exchange ideas apart from work topics.

In good weather, we get outside at lunchtime in our own “forest tavern” in the backyard. It stands right next to that of our neighbor 3di. The company has also just moved into the building. The team produces implants, i.e. medical products. They are therefore also active in the medical technology industry and work in a similar way in terms of regulatory requirements.

The new location brings further advantages to our company and our employees: In addition to the proximity to the city center and better parking facilities, it also guarantees sufficient work space for everyone at the same time, even in the current Corona period.

Thus, we are optimally equipped and motivated to tackle new stages in our company’s history.

The biotechnology company oncgnostics GmbH is researching a method for diagnosing Head-and-Neck tumors together with the clinical department for general ENT at the Medical University of Graz as part of the “OroCa-Graz” study. 550,000 people worldwide develop carcinomas of this type every year. As only advanced stages of tumours are often diagnosed, more than 300,000 of those affected die each year. The study aims to demonstrate that the diagnostic method developed for Head-and-Neck tumors and especially mouth and throat cancer (= oropharyngeal cancer) can reliably and early detect malignant tumors using non-invasive saliva samples.

Excessive alcohol and tobacco consumption are among the main risk factors for Head-and-Neck cancer. In addition, there has been an increase in cases of carcinoma in the mouth and throat area in recent years, in which infection with the human papillomavirus (HPV) was found. The rate of these HPV-associated cancers increases by 2.1 percent annually. Non-HPV-associated Head-and-Neck cancers decreased slightly by 0.4 percent over the same period[1]. In Germany, a current proportion of 40 percent of HPV-induced diseases is assumed, and the trend is rising[2].

The “OroCa-Graz” study is led by Prof. Dr. Dietmar Thurnher, Head of the General ENT Department at the Medical University of Graz. He explains: “Despite increasing cases, the treatment of Head-and-Neck cancer has not made any significant progress in the last 20 years. Beside new diseases, half of the patients return as so-called tumor recurrence within the two years after completing therapy. Furthermore, no early diagnosis has yet been established for Head-and-Neck tumors. Our goal is to change that. By examining the relationship between oropharyngeal carcinomas, HPV infections and DNA methylation markers, new ways of early diagnosis as well as secondary and tertiary prevention are emerging.”

Secondary prevention is aimed at people with an increased risk of disease, for example smokers. With preventive examinations, clarification as well as screening tests, malignant diseases, especially in risk groups, could be diagnosed at an early stage or abnormalities could be clarified. Until now, the throat is inspected when symptoms arise. Tertiary prevention measures are aimed at tumor patients who are in regular clinical follow-up after treatment.

“OroCa-Graz”: Course of study

As part of the “OroCa-Graz” study, tissue and saliva samples from patients with oropharyngeal cancer are examined comparatively. By submitting a simple saliva sample, complaints in the head and neck area should be clarified later. The detection of a malignant disease is carried out via the detection of tumor-specific DNA methylation markers, which were developed by oncgnostics. The HPV status of all samples is also determined. Based on these results, the scientists analyse how sensitive the tumor detection by the methylation markers is and whether there is a connection between the occurrence of the tumor markers and an HPV infection.

Additional saliva samples are taken during follow-up. The idea is that tumor markers that have already been detected in the primary tumor return in the development of recurrences. If the tumor markers are detected in the follow-up, action can be taken at an early stage.

Research on DNA methylation markers since 2012

Since its foundation in 2012, oncgnostics GmbH has been specifically engaged in the search for DNA methylation markers, including Head-and-neck tumors. So far, a set of potential tumor markers based on tissue and swab samples has been established for the disease. One of these tumor markers is already used in the diagnosis of cervical cancer in the GynTect® test.

“Changes in the DNA methylation pattern occur early in tumor development. By detecting our cancer-specific biomarkers, we can check, for example, if cancer precursors are present. In the future, the application could be a powerful tool for early detection in the context of cancer screening and as part of the follow-up examinations for oropharyngeal carcinomas,” said Dr. Martina Schmitz, CEO of oncgnostics GmbH.

[1] Universität Leipzig (2020): Oropharynxkarzinom: Gute Prognose – aber nicht für alle Patienten. Online available: https://www.quintessence-publishing.com/deu/de/news/nachrichten/bunte-welt/oropharynxkarzinom-gute-prognose-aber-nicht-fuer-alle-patienten

[2] Wagner S. et al. (2018): Das HPV-getriebene Oropharynxkarzinom – Inzidenz, Trends, Diagnose und Therapie. In: Der Urologe 57:1457–1463. Online available: https://pubmed.ncbi.nlm.nih.gov/28713770/

Anwendung der PCR-Methode im oncgnostics-Labor

The method of the PCR stands for the polymerase chain reaction. The underlying process has fundamentally changed medical and biotechnological research. It is now considered the most important laboratory method for investigating the molecular structure of our genetic material (= DNA). This is partly due to the fact that the PCR analysis is versatile. It is used in all oncgnostics projects and is an elementary part of our GynTect test for cervical cancer. However, the PCR test recently gained publicity through its use in the current worldwide testing of Corona.

What is PCR used for?

Laboratories use the methodology for amplifying DNA in the shortest possible time. Quick runs, so-called Fast-PCRs, take place within 10 minutes. Others last between one and two hours.

Take our cervical cancer test GynTect: The aim of the PCR is to find out whether certain, epigenetically modified gene sequences that only occur in cancer cells, are present. These are known as methylation of DNA.

In order to clarify this question via PCR based diagnosis, you need the following:

  • DNA from the sample to be examined. The sample is taken at the gynecological practice where the affected woman is cared for.
  • Nucleotides: These are the basic chemical building blocks of DNA which are needed to make copies of the given DNA strand.
  • Polymerases: This is a class of enzymes that is essential for the replication of DNA.
  • Specific primers: The artificially generated, short oligonucleotide chains serve as starting molecules for the polymerase. They dock on the DNA strand, marking the point at which the polymerase begins its work. Depending on which regions (= biomarkers) of the DNA are to be detected, other primers serve as keys for the PCR method.
  • Finally, a buffer solution is needed in which the reaction runs and which keeps the pH during the reaction stable.

Polymerase chain reaction: Process in the thermal cycler

The replication of the DNA usually takes place in three steps in a so-called thermal cycler. This laboratory device regulates the exact temperatures during the biochemical reaction.

  1. The first step is denaturation. The sample is heated to 94-96 °C. This causes the two strands of the double-stranded DNA to separate from one another.
  2. For the second phase of primer hybridization, the sample is rapidly cooled down to 50-65 °C. The respective temperature depends on the primers used, which serve as specific keys as described above. The primers now dock at the suitable points on the two single strands of the DNA.
  3. In the final step of elongation, also called extension, the single strands of the DNA become double strands again. The temperature is increased again to 68-72 °C. The polymerase attaches to the small areas of double-stranded DNA that were created by the primers. With the help of the loose nucleotides, it completes the double strand.

In the last phase, around 500 base pairs are formed within 30 seconds. The length of the third step depends on the length of the DNA sequence to be examined. Once the third step is completed, a new PCR cycle starts. As a result, the DNA amount in the areas of the markers to be detected increases exponentially. More than one billion copies can be available after just 30 cycles. The entire process usually takes one hour.

Important: The DNA sample is only duplicated if it contains the gene sequence you are looking for. In the case of GynTect or Corona, the DNA sample would be positive in this case.

PCR for diagnostics: What happens when using GynTect?

When performing GynTect, we use the described procedure. If there is a methylation of DNA for the corresponding gene sequence, which occurs exclusively in cancer cells and cancer precursor cells, the DNA can be replicated using specific GynTect primers. The result is positive. In this case, the sample lights up.

A specific fluorescent dye is applied for the optical signal. In successive cycles, this is repeatedly stored in double-stranded pieces of DNA that the PCR generates. The more duplicated DNA there is, the stronger the light signal. The cycle from which the resulting luminous signal significantly exceeds the background light is called the Cycle threshold, also known as Ct. For the GynTect test, a certain amount of DNA methylation data is at least necessary for a sample to be recognized as positive. However, the proportion is less than one percent. For Corona PCR tests, some few viruses in a sample are required to yield a positive result. The lower the Ct value, the more viruses were present in the original sample.

If the sample is negative, no methylation of DNA is detected. In this case, the PCR does not generate any DNA fragments and the dye is not stored anywhere. Accordingly, the sample does not emit a light signal.

You can see the preparation of the PCR for GynTect in this video.

Advantage and history of the PCR analysis

The advantage clearly lies in its ease of use. The tool proves specific genetic information in an uncomplicated and targeted manner. Here it is key that the primers specifically recognize the target sequence. In the example of GynTect, we apply primers that only fit certain, in this case six different, gene regions, and the primers only fit if the regions were previously methylated.

Research into the diagnostic method dates back to the 1950s. In its present sense, it was invented in 1983 and only 10 years later, in 1993, it was awarded the Nobel Prize for Chemistry. Today, many different PCR thermal cyclers are used in most laboratories.

2020 was a challenging year – also for our company. Nevertheless, we look back on successful achievements.

GynTect® convinces in test comparison

In November, the journal Clinical Epigenetics published a comparative study on cervical cancer diagnostics tests. Two tests based on epigenetic markers, oncgnostics’ GynTect® and QIAGEN’s QIAsure, were tested on a selection of patient samples. Both tests may be used to identify clinically relevant, HPV-induced cervical disease that may develop into cancer. The aim of the study was to determine not only the sensitivity but also the specificity of the tests, which means how frequently a test delivers a false-positive result. Both tests demonstrated a very good sensitivity for high-grade lesions, especially for cancer cases. However, for GynTect®, the specificity was significantly higher, which means that the rate of false-positive results among healthy HPV-positive women was much lower. Thus, GynTect® may be preferable, due to its higher specificity for CIN2+ or CIN3+.

Achievements: active in research despite Corona

In August 2020, a study on psychological stress in connection to abnormalities found in cervical cancer screening was published, with our contribution. More than 3700 women participated in this scientifically supported online survey. Women with abnormal Pap smear findings or with an HPV infection stated, among other concerns, that they are worried about developing cancer. Even though neither an abnormal Pap smear finding nor an HPV infection does provide a reliable indication of cancer. Nearly half of those affected even expressed fears of dying from cervical cancer. The results were published in the journal Archives of Gynecology and Obstetrics.

Furthermore, we have made significant progress in the diagnostics of Head-and-Neck tumors: Since 2019, we have developed a test based on proprietary DNA methylation markers that may be used in Head-and-Neck cancer diagnostics. In 2020, the corresponding study “OncSaliva” started in the University Hospital Jena. Four more centers will be added by the end of the first quarter of 2021. A total of 150 patients provide saliva and blood samples at the time of their cancer surgery. In addition, we obtain tissue samples from the tumor for analysis. The samples are tested for the methylation markers. 150 healthy subjects are also included, from whom tissue and saliva samples are collected. During the subsequent post-surgical follow-up care, the patients enrolled in the study regularly provide saliva samples for recurrence detection for up to two years. Our scientists analyze the methylation markers in the saliva. This non-invasive method may enable a timely detection of recurrences in the follow-up. The study will run until the end of 2023.

Outlook for 2021: New cooperation and appearance at Eurogin

The results of the GynTect®-PRO study will be available in May. Our company started a three-year follow-up study with the GynTect® test procedure in 2017. For this trial, patients from ten study centers in Germany were enrolled. It is intended to show that young patients with a negative GynTect® result do not develop cervical cancer despite conspicuous changes observed at the cervix uteri. Instead, the cell changes heal by themselves.

In 2021, we will reach another milestone in our international sales activities. Our company recently negotiated a partnership with the international diagnostics group EUROIMMUN, a PerkinElmer company.

Save the Date: We will participate at the international, multidisciplinary HPV congress Eurogin from May 30th to June 1st 2021.

 

Picture: Pharmaceutical biotechnologist Theresa Erler in the oncgnostics laboratory / © Eberhard Schorr

The World Health Organization (WHO) sees an increasing HPV vaccination worldwide as a great opportunity in the fight against various types of cancer. At the organization’s annual meeting, WHO director Tedros Adhanom Ghebreyesus declared that he wanted to use the HPV vaccine more widely. The aim is to act against the globally increasing cases of cervical cancer. With additional treatments and new tests, five million deaths could be avoided by 2050 and many lives could be saved, said Ghebreyesus[1].

What is the strategy of WHO? In the following, we will take a closer look at the dangers coming from a human papillomavirus infection (HPV). We will also discuss the opportunities that vaccination offers against HPV.

What happens with an HPV infection?

HPV infection is primarily a sexually transmitted infection. In fact, most sexually active people become infected with the virus at least once in their lives[2]. However, most HPV infections have no apparent symptoms. They heal on their own. They can no longer be detected after just one or two years.

Regardless of the inconspicuous course, a distinction is made between low-risk HPV types and high-risk HPV types. The former is, for instance, responsible for HPV genital warts that require medical treatment. If an infection with high-risk HPV does not heal by itself, it can develop into cancer through various preliminary stages. This lasts on average 10 to 15 years[3].

According to the Center for Cancer Registry Data, around 6,250 women and 1,600 men develop HPV-related cancers in Germany every year[4].

Types of cancer caused by HPV include:

  • Cervical cancer
  • Carcinomas in the genital area: vagina, vulva, penis and in the anus
  • Head-and-Neck tumors in the area of ​​the throat, tonsils and the base of the tongue

What diseases does HPV vaccination protect against?

Vaccines against the main high-risk types of HPV have been around for several years[5]. The human papillomavirus vaccine has been used in Europe and the USA since 2006. In 2020, a first study from Sweden demonstrated the success of vaccinating against cervical cancer. According to the study results, women who were vaccinated against HPV up to the age of 17 had an 88 percent lower risk of cervical cancer than unvaccinated women[6].

Furthermore, the vaccine is used as a preventive measure for Head-and-Neck malignancies. Anna-Bawany Hums works as a molecular biologist in the research and development department of oncgnostics GmbH: “Head-and-Neck tumors that are traced back to papillomavirus develop over even longer periods of time than cervical cancer. Therefore, there are no current studies that show the effects of HPV vaccinations on these cancers[6]. This makes it all the more important to improve the diagnosis for this disease at the same time. We at oncgnostics are researching how to detect Head-and-Neck tumors in their early stages using non-invasive diagnostic methods. In this way we want to increase the chance of a therapeutic success. The earlier cancer is detected, the better the prospects of a cure are for those who are affected”.

Who should be vaccinated?

The German Standing Committee on Vaccination (STIKO) states that the most effective HPV vaccine age, both for boys and girls, should be between 9 and 14. Child vaccinations should be executed due to several reasons:

  • Protection against individual HPV types can no longer be established if there is a permanent infection or even a precancerous stage. The HPV vaccination is therefore ideally carried out before the first sexual contact is made. Missed vaccinations should be made up as soon as possible. This can be done up to the age of 17 years.
  • Studies show that younger girls have a better immune response to the HPV vaccine than older girls. Correspondingly, vaccination for kids only requires two doses of vaccine.

Whether you are vaccinated or not: HPV Prevention is central

HPV-induced cancers develop over many years and precursors. Even after the HPV vaccination, a residual risk remains. Regular preventive examinations are therefore of crucial importance. In Germany, for instance, a new program for early detection of cervical cancer has been in place since 2020. The program includes co-testings with Pap smear and HPV test for women aged 35 and over.

At its annual meeting, the WHO urged the 194 member countries that at least 70 percent of women should be tested for cervical cancer by the age of 35. In addition, by 2030 at least 90 percent of girls should be fully vaccinated against HPV before they turn 15 years old.

There are still no standardized rules worldwide on systematic preventive examinations for Head-and-Neck tumors. Therefore, it is important to consult a doctor soon in order to clarify complaints in the mouth and throat area at an early stage.

 

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[1] WHO stellt Strategie zur Bekämpfung von Gebärmutterhalskrebs vor. In: Ärzteblatt, 17. November 2020. Online:  www.aerzteblatt.de/nachrichten/118411/WHO-stellt-Strategie-zur-Bekaempfung-von-Gebaermutterhalskrebs-vor

[2] Robert Koch Institut (2020): HPV (Humane Papillomviren): Antworten auf häufig gestellte Fragen (FAQ) zu Erreger und Impfung. Online:  www.rki.de/SharedDocs/FAQ/Impfen/HPV/FAQ-Liste_HPV_Impfen.html;jsessionid=3F10B057E8CD109E0C8EF04167FB32E6.internet072?nn=2375548

[3] Bundesgesundheitsministerium (2020): Verbesserte Früherkennung von Gebärmutterhalskrebs seit Januar 2020. Online: www.bundesgesundheitsministerium.de/themen/praevention/frueherkennung-vorsorge/frueherkennung-von-gebaermutterhalskrebs.html

[4] Robert Koch Institut (2018): RKI-Ratgeber. Humane Papillomviren. Online: www.rki.de/DE/Content/Infekt/EpidBull/Merkblaetter/Ratgeber_HPV.html

[5] Krebsinformationsdienst: Humane Papillomviren und Krebs. Online: www.krebsinformationsdienst.de/vorbeugung/risiken/hpv.php

[6] Robert Koch Institut (2020): HPV (Humane Papillomviren): Antworten auf häufig gestellte Fragen (FAQ) zu Erreger und Impfung. Online: www.rki.de/SharedDocs/FAQ/Impfen/HPV/FAQ-Liste_HPV_Impfen.html;jsessionid=3F10B057E8CD109E0C8EF04167FB32E6.internet072?nn=2375548

 

Almost half of mankind owns this organ and every human life starts in it: the uterus. At the latest, with the first menstruation every woman becomes aware of her own uterus. But how exactly does the female reproductive organ look and what functions does it fulfil?

The uterus is one of the female internal reproductive organs. It consists of muscles whose shape resembles an inverted pear and is located slightly above the pubic bone. In an adult woman, the womb is 7-10 cm and weighs 50-60 g. It is supported by the pelvic floor muscles.

The uterus consists of two parts

Uterus Womb

The upper, thicker part of the uterus is called the body (Corpus Uteri), whilst the lower, narrower section forms the cervix (Cervix Uteri).

In the upper part of the uterine body, the fallopian tubes are located on both sides and transport the mature egg into the uterine cavity, where a fertilised egg may implant itself and develop into an embryo, in other words, a baby. However, this requires a well-built endometrium. Hormonal factors cause the endometrium to regenerate cyclically. If no pregnancy occurs, it is shed and menstruation occurs.

The connection between the uterus and the vagina is the cervix; while the cervical canal opens into the womb, the external orifice of the uterus leads to the vagina.

The uterus during pregnancy

When a baby is developing in the womb, the uterus does amazing things: it expands, stretches and thickens to accommodate the developing baby, the placenta and the amniotic fluid. The womb alone can weigh about one kilo during pregnancy. During birth, the muscles of the womb contract and different contractions eventually help to give birth to the baby.

Uterus diseases

If the pelvic floor is weak, the uterus may sag. Besides, benign tumours, so-called myomas, may form in the musculature of the uterus. A very common gynaecological disorder is endometriosis. The endometrium is mislocated outside the womb, which often is very painful for women and frequently leads to failure to conceive.

Uterine cancer affects the uterine body and is usually caused by hormones, but sometimes also by genetic predisposition. Unusual bleeding may be a symptom of cancer and should be checked.

For example, if a woman becomes infected with HPV (Human Papillomavirus) during sexual intercourse, in most cases, the HPV infection heals on its own. However, in rare cases, the infection persists and changes the tissue around the cervix. These changes (dysplasias) may also regress. However, precancerous stages up to and including cervical cancer may develop. For this reason, it is important to regularly visit the gynaecologist for a cancer screening, to detect cervical cancer early. If possible, in its preliminary stages.

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Cover Foto: GoodStudio/Shutterstock.com
Graphic: Blamb/Shutterstock.com

During the first days of March, Dr. Alfred Hansel took a close look at the healthcare system of Cuba. The Managing Director of oncgnostics GmbH participated in the Cuban-German Healthtech Summit in Havana. Cervical cancer and its early detection is a big issue in Cuba.

Dr. Alfred Hansel, Managing Director of oncgnostics GmbH, attended the event to get a first-hand impression of the Cuban health-care system and the corresponding market. During a delegation trip organised by the German Federal Ministry for Economic Affairs and Energy, representatives of 10 German companies from the medical sector met with representatives of the Cuban health-care industry. The latter gave an insight into their work and the Cuban health care system, while the German companies gave short presentations to the Cuban audience. Opportunities for cooperation were discussed in subsequent bilateral talks. Dr. Hansel had a particularly thorough exchange with representatives of the Hermanos Ameijeiras Clinical-Surgical Hospital, who was very interested in GynTect, the cervical cancer screening test developed by oncgnostics GmbH, and who invited Dr. Hansel for a visit at the hospital’s lab.

Early detection of cervical cancer

The Cuban health-care system is progressive. Pap smears have been used for cervical cancer screening since the late 1960s. Cuban women can undergo the test once every three years. And it was successful! The number of new cases as well as the death rate fell steadily. But since the 1990s the trend has reversed, with more and more women suffering from cervical cancer and even more women dying of it. The reasons are yet unknown. An examination every three years may not be enough. Moreover, only about 70% of women actually go for the regular cervical cancer screening.

Cooperation on a study

The Hermanos Ameijeiras Clinical-Surgical Hospital, the largest hospital in Cuba and a reference centre for research and education, would like to contribute to improving cervical cancer prevention in Cuba by means of a clinical trial in the near future.

‘Representatives of the hospital showed great interest in GynTect, our test for the detection of cervical cancer, and are currently in the starting phase of a study that will demonstrate the advantage of the HPV test over the Pap smear. We have talked intensively about using GynTect to complement the study. In the next few days, we will develop the ideas raised in Cuba in order to possibly implement them soon’, says Dr. Alfred Hansel

Human papillomaviruses are a group of widespread viruses. In most cases, people affected by the virus are unaware of the infection. However, certain types of HPV are responsible for the development of tumours, such as cervical cancer.

Almost everyone gets infected with HPV at some point in their lives. HP viruses are mainly transmitted by skin-to-skin contact, but also by sexual intercourse. The infection often remains undetected because no symptoms are noticed and the infection heals by itself. However, harmless or unpleasant warts, such as genital warts, can occur. In a few cases and with certain types of HPV, chronic HPV infection occurs, which can last for several years. This can lead to malignant cell changes. The consequence may be precancerous lesions or cancer. In particular, HP viruses are responsible for the development of cervical cancer. However, tumours in the mouth, vagina, penis and anal area can also be caused by human papillomaviruses.

High-risk HPV types

Not all HP viruses are causing cancer. To date, more than 200 HPV types have been conclusively identified, according to the Robert Koch Institute. They can be classified into five different groups: Alpha, beta, gamma, mu and nu HPV. Only the alpha-HPV group can infect the skin and mucousal cells in humans.

In general, these types can be subdivided into high- and low-risk types. The low-risk types (“low risk” viruses) can cause warts in the genital area. However, a life-threatening disease can be rarely feared when infected with low-risk HPV types. In contrast, high-risk types (high-risk viruses) can cause malignant cell changes, i.e. cancer.

Protection against HPV infection

Vaccination against HPV is the most effective protection against an HPV infection. Not even condoms provide sufficient protection during intercourse. Children aged nine and older can be vaccinated against certain high-risk HPV types. In general, vaccination should preferably be applied before the first sexual intercourse. This is true for both boys and girls alike, because vaccination not only protects against cervical cancer. There are also other types of cancer associated with HPV, as mentioned above. In addition to vaccination, women should visit their gynaecologist regularly for cancer screening.