CC Diagnostics with new cervical cancer test on the way to European certification

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Why we write about this topic:

Every year around 800 people in the Netherlands are diagnosed with cervical cancer. Women have regular check-ups, but many find the accompanying check-ups uncomfortable. High time for innovations in this area.

Things are going well for CC Diagnostics. The start-up from Groningen in the Netherlands is developing a new test for cervical cancer that works more efficiently and is said to be more user-friendly for female recipients. The company is currently conducting a large-scale study in order to obtain CE certification and thus be able to conquer the European market. “We can be proud of where we are today,” says co-founder Nutte van Belzen.

Women over 30 are regularly screened for cervical cancer in the Netherlands. These include painful tests like pap smears and occasionally biopsies. CC Diagnostics’ new test can now replace the current PAP test currently used in population screening. The new so-called Methica test enables women to take their own test samples at home with a self-test kit, thereby fully participating in population screening. This allows early detection of cervical cancer and possibly other diseases caused by the cancer in the future Human papillomavirus (HPV), such as ovarian cancer.

How does the CC Diagnostics test work?

The origin of cancer lies in the DNA of cells. CC Diagnostics examines three specific genes that protect a cell against cancer. However, this protective function can be gradually lost, leading to early-stage cancer. The so-called Methica test examines DNA damage in order to detect changes at an early stage. According to the startup, the test is more accurate than the PAP test.

CE marking

Over the past few years, CC Diagnostics has pulled out all the stops to show the outside world that the new test is valuable to the medical world. Several studies with relatively small sample sizes have already demonstrated the added value of the test kit. Now it’s time for the next step.

“We are very happy with the steps we have been able to take recently,” says Van Belzen, who is not only an entrepreneur but also works as a doctor at Leeuwarden Medical Center. “At the moment we have our product ready so that we can start supplying laboratories. You have access to biological material. These collaborations allow us to validate our test kit with material that would otherwise end up in the trash. We are conducting a very extensive study. We need this data in order to be able to obtain the CE marking.” In short: “This is an important time for us and I am so glad that we are now at this point.”

Hooker van Belzen

The start-up supplies test kits to three leading medical laboratories in the Netherlands, including the University Medical Center Groningen (UMCG). “Our technology was also developed at the UMCG. Before we started our company, researchers studied this technology for the last 14 years. They help us build studies, evidence-based research, and therefore the research we are currently focusing on.”

screening at home

In addition, women can now opt for a self-test kit to detect HPV, which is then sent to a laboratory. However, the lab is unable to test for abnormal cells in the body caused by the virus. Therefore, whenever HPV is detected, women must have a Pap smear at their GP’s office.

“One of the key benefits of our test kit is that if you test positive for HPV, you don’t have to go to your doctor’s office for a Pap smear, the PAP test,” explains Van Belzen. “Because our test can be applied to materials from our own tests. This saves you an additional visit to the doctor and waiting times. Lowering the threshold for an HPV test is crucial. About 15 percent of women who are diagnosed with HPV do not even dare to visit their family doctor. “I hope that we can do something about this and I expect that self-test kits will eventually become more and more of the future.”

“Like a Trial”

However, the process of obtaining the European CE mark is not usually without setbacks. A major obstacle, according to Van Belzen, is the long period of uncertainty that a company faces during the process, even if the product could still be rejected late in the process. “Sometimes it’s like having to defend yourself in court. You are dealing with laws, regulations and people who have to make a decision about our product based on legal requirements. We have to build up an extensive file in which we have to present more and more evidence, all of which must be reproducible.”

Sometimes part of the process has to be repeated. “Of course, this has a huge impact on the throughput time of your company,” continues Van Belzen. “If you need to repeat research, it can take up to a year longer.” Carrying out extensive research for CE marking will take CC Diagnostics about a year and a half, predicts Van Belzen. “Let’s hope our process goes as quickly as possible.”

team extension

Now that the company is growing rapidly, it also faces another major challenge: it’s time to expand the team. “During the Corona period, we mostly worked remotely. But at the moment we work closely together as a team in our office. In this growth phase that we are going through, we are looking very intensively for employees and interns.” For Van Belzen, there is no question that the company can offer new employees a good place. “In this way we can give back to the Groningen ecosystem something that has meant a lot to us in the past and continues to be very important,” he concludes.

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