The need – who benefits from the idea?

The two company founders are aiming to play a part in improving oral health. After all, gum disease is an extremely widespread condition that affects a significant proportion of the population. “Just under 35 million people suffer from it in Germany,” Frey explains. Periodontitis, also known as gum disease, is a chronic inflammation of the periodontium, which ultimately destroys the tissue and bones responsible for holding the tooth. The number one cause of gum disease is plaque that builds up on the gumline and between the teeth. This plaque is made up of numerous bacteria whose metabolic products trigger inflammation and contribute to changes in the bacterial composition. Initially at least, this process is painless. Patients therefore don’t notice what is happening until their gums start to recede, the bone structure breaks down, and their teeth ultimately fall out. “Early diagnosis is vital if the teeth are to survive,” says Frey.

The Oralgenix test is suitable for every phase of treatment at the dentist. It could be that the doctor has already established that the patient has periodontitis and now wants to improve treatment by getting precise knowledge of the microbiome. This is especially true for cases of advanced periodontitis, where knowing which bacteria are triggering the inflammation will help dentists intervene quickly and decide on the correct antibiotic. Alternatively, it could be the patient is already suffering from very advanced periodontitis and no antibiotic has been effective thus far. In this case, the test can be used to check whether bacteria are actually to blame, or whether there could be a genetic cause, and antibiotics would be no help at all. Then, of course, there are also patients who have no symptoms but go for regular checkups – in these cases, preventive diagnostics help identify changes in the microbiome that could lead to gum disease in the near future. If the diagnosis is made early enough, periodontitis can be cured in most cases – the condition is only chronic in around ten percent of patients.

In actual fact, periodontitis is not a disease that is limited to the oral cavity. It has now been established that many other diseases can be associated with bacterial inflammation or the mouth microbiome. “There are numerous studies that seem to indicate a direct correlation between bacteria in the oral microbiome and arteriosclerosis. Some of these bacteria can also take hold in parts of the heart. Likewise, there is data that points to a link with the initial development and progression of Alzheimer’s disease,” Frey explains. The presumption could therefore be wrong that people who have Alzheimer’s – and are less careful with their oral hygiene as a result – go on to suffer from periodontitis. It could well be that patients who have periodontitis are more likely to develop Alzheimer’s.

The USP – what is the innovation?

“Our test is preventive. It is effective before the periodontitis is present – unlike most other tests, which are only effective once the disease presents,” says Frey, explaining the unique selling point of his product. It is important to the company founders that they are not providing a diagnosis with their method – that remains a task for the dentist. “We provide the medical professionals with information about the microbiome that correlates with periodontitis, enabling them to make their diagnosis earlier.”

The two scientists have succeeded in doing more than just interpret data. “We can identify the changes in full, and we complement our analysis with many customised parameters,” Frey explains. “We can detect resistance genes that would rule out the use of certain antibiotics. What’s more, there are some special cases where the periodontitis has genetic causes. This probably amounts to less than five percent of cases, but five percent is not nothing when there are 35 million patients.” Oralgenix can provide data to these patients, too, enabling the dentist to begin appropriate treatment. “Our preventive screening considers all the changes in the microbiome. This enables us to make individual assessments for each patient,” says Urban. Since so many parameters have to be taken into account, the algorithm used is extremely complex. The company founders view the interpretation of the data as their intellectual property, and they are certain that this is their unique selling point. Not only could the Oralgenix idea revolutionise preventive dental care for the better, it could also lead to a huge reduction in healthcare costs. “Every euro invested in preventing periodontitis achieves a more than 80-euro return,” Frey calculates. “It is a brilliant investment for private individuals and for the entire healthcare system.”

However, the idea the company founders had goes far beyond preventive care at the dentist. They would like to develop another test that will be readily available in chemist’s shops. This test would be able to investigate the causes of bad breath, white tongue, or a predisposition to cavities. Ultimately, they hope to make it as easy to use as a COVID test. Getting a periodontitis diagnosis at the dentist and determining the pathogen involved, on the other hand, is a much more complicated procedure. “It’s not just a cheek swab,” Urban explains. “Several small paper points must be introduced directly into the neck of the teeth to ensure samples are taken correctly.” The samples are then processed at Oralgenix, and the DNA is isolated and analysed.

Milestones – what happens next?

It goes without saying that the regulations here pose a huge challenge for the start-up. “That’s why we’re not just targeting German-speaking countries, but also the United States and Canada.” Their commitment to Germany as a location remains unchanged, however. “We feel comfortable here, and we intend to stay in the STERN BioRegion with its strong biotech scene. We get a lot of support here, not least from Tübingen and Reutlingen business development. On top of that, ‘Made in Germany’ still commands a lot of respect around the world.” The next step for the two scientists is to complete the test analytics and relevant validation. Currently, the company is still being supported in this by an external laboratory, but it has already rented rooms in the Reutlingen technology building to create space for its own laboratory equipment.