Question 1

What does the DNA test show?

Accepted Answer

The Bsure DNA test for filler treatments shows whether you have a genetic predisposition to severe rejection reactions after a filler treatment.

The scientific research and the research population on which the Bsure DNA test is based shows that if you have a certain genetic predisposition there is an 84% chance of these severe rejection reactions.

Question 2

What exactly is a genetic predisposition to get a disease or medical complication?

Accepted Answer

It is the predisposition that you have from birth, which is stored in your DNA, to suffer from a physical characteristic or a disease.

Question 3

What are the chances of having the extreme immune reactions to fillers?

Accepted Answer

There are people who have a genetic predisposition that causes that their own immune system reacts extremely to fillers. The fillers are then rejected by the body. Medical complications that can occur include chronic and/or localized inflammation that may require months or years of medical treatment and can have lifelong consequences.

The chance of these serious rejection reactions occurring is small. However, if they occur, the consequences can be serious. Several studies have been done on the risk of these serious complications. The risk of rejection phenomena varies in these studies from 0.4% to 4% of the cases . The medical-scientific team involved in the Bsure study estimates the chance, based on their own experience and research, at 1 to 3% of the cases.

Question 4

What kind of complications in filler treatments is the Bsure DNA test for?

Accepted Answer

Dermal fillers can cause mild, temporary complications, such as localized inflammation or irritation. These complications usually disappear after a few weeks or are treatable.

The Bsure DNA test is aimed at determining your risk for serious complications caused by a genetic predisposition that makes the own immune system react extremely violently to fillers. These serious complications can manifest themselves in the first 3 to 6 months after treatment, but also after 5 to 8 years.

These are the so-called late immune-mediated adverse reactions to fillers. The chance of these reactions is small (0.4 to 4%), but the consequences are complex and serious. They can become chronic complaints that require months, years, or in some cases lifelong monitoring and treatment.

Our medical-scientific team is specialized in complications and can therefore provide excellent advice on the treatment of these cases.

Question 5

Is the DNA test based on scientific research?

Accepted Answer

The DNA test is based on scientific research, performed by a world-renowned medical scientific team of doctors and experts in this field. They work at Amsterdam UMC, Erasmus MC in the Netherlands and the Vall d'Hebron Barcelona Hospital in Spain. In this link you will find a scientific article about this research.

Question 6

Will I know for sure after the test whether I have an increased risk of serious rejection reactions after a filler treatment?

Accepted Answer

The Bsure DNA test has a positive predictive value of 84%, in the study population from the scientific article.

The specificity is 95%. This means that when the test is negative, 1 in 20 patients has falsely tested negative.

So: with a positive result of the test there is a high risk of complications. If the test is negative, this means that the risk is very low, but not completely excluded.

Question 7

What do I do when the DNA test result is positive?

Accepted Answer

If the DNA test result is positive, this means you have a genetic predisposition of having a high risk for filler complications. Therefore, it is highly recommended not to proceed with filler treatments. Botox and PRP treatments can be used in case of a positive test result and have not shown cases of late onset immune mediated adverse reactions, according to our expertise and literature. There always exists a low risk they could cause general complications. You can ask your doctor for further advice, possibly in collaboration with out medical-scientific advisory team. The alternative for fillers, to give volume, is lipofilling, with you own bodyfat.

Question 8

Is it necessary to take the test if I have had a filler treatment before?

Accepted Answer

Yes, it is a possibility that even if you have not had any complications before, you can still develop one. The Bsure DNA test detects the risk of late-onset immune mediated complications; these are reactions that can only manifest themselves months or even years after treatment with fillers. After several filler treatments, the risk and especially the severity of the reaction of your immune system increase. The possible different types of fillers that are used also have an influence.

Question 9

I've already had filler treatments. What should I do if the DNA test result is positive?

Accepted Answer

Your chosen doctor, who is a member of the Bsure network, will discuss the results with you. This doctor will provide appropriate advice, possibly in collaboration with our medical-scientific advisory team.

Question 10

What does the test exactly analyse of my DNA?

Accepted Answer

Everyone has specific immune cell receptors on the outside of the cells. These are so-called HLAs: Human Leukocyte Antigens. These are part of the human immune system. The HLAs can recognize whether something is natural or foreign. They ensure that your body recognizes and attacks a bacteria or virus, so that your body remains healthy.

The Bsure DNA test for fillers is aimed at finding out which genetic predisposition you have for the HLAs. The scientific study on which the Bsure DNA test fillers is based[1], showed that the combination of the HLAs DRB1*03 and B*08 causes an increased risk of immune-mediated rejection reactions to fillers. The Bsure test determines whether someone has this combination of HLAs.

These HLAs are located on the short arm of chromosome 6. There are more than a million combinations and thus different HLA typologies. Analysing and detecting a specific combination of HLAs is therefore a complex and expensive process.

[1] Tom S. Decates,Peter J. Velthuis,Leonie W. Schelke,Neubury Lardy,Eduard Palou,Simo Schwartz,Yara Bachour,Frank B. Niessen,Tamar Nijsten,Jaume Alijotas-Reig. Increased risk of late-onset, immune-mediated, adverse reactions related to dermal fillers in patients bearing HLA-B*08 and DRB1*03 haplotypes;

Dermathology Therapy, January/February 2021, e14644

Question 11

What is the chance of having the HLA combination?

Accepted Answer

According to general statistics 1,6% of the EU population has the combination of the HLAs DRB1*03 and HLA B*08. (source: http://www.allelefrequencies.net/hla.asp)

Question 12

Where and by whom will my DNA sample be analyzed?

Accepted Answer

Your DNA sample will be sent to the Fagron Genomics laboratory in Terassa, Barcelona (Spain). Fagron Genomics (https://www.fagrongenomics.com/) is part of the multinational FAGRON B.V., a pharmaceutical company headquartered in Rotterdam, the Netherlands.

The Fagron Genomics laboratory does not have your personal data and only uses the barcode of your DNA sample. We have an extensive quality agreement with Fagron Genomics, which complies with all European regulations and quality requirements.

Question 13

Is it painful to take the test? How is the test taken?

Accepted Answer

No, it's a simple saliva sample with a cotton swab and completely painless.

Move the swab between cheek and gums on both sides of the mouth. Helping yourself with your other hand, press down lightly on the cheek and rub the swab forcefully back and forth ten times.

Question 14

Can I also receive the results of the test at home?

Accepted Answer

No, the results are provided by a physician from a clinic affiliated with the Bsure network of quality physicians. When purchasing the test, you must make a choice for one of these doctors and/or clinics. A doctor will contact you and give you the results of the test by phone or e-mail or during a personal meeting in the clinic.

Question 15

Is my data kept safe and not shared with third parties?

Accepted Answer

The security of your personal data is very important to us. Our platform fully complies with the GDPR requirements. Your data is kept safe and is not shared with third parties apart from the laboratory that executes the DNA analysis. However, the laboratory only will have access to your anonym barcode which identifies your sample. The only person who can see your data is the doctor who informs you of the result of the test. We have strict agreements with the doctors that guarantee that they adhere to our privacy policy and they also have their own GDPR compliance. When the results of your DNA test are known and discussed with the doctor, you can have your data and the DNA sample removed.

Question 16

Bsure Medical is a social enterprise, what does that mean?

Accepted Answer

A social enterprise aims to make a sustainable contribution to society. The focus is not solely on generating shareholder value and the mission consists of a higher purpose that can benefit society as a whole. Bsure's mission is to promote the safe and responsible use of foreign body implants. Part of the revenues will be used to enable future scientific research in the field of foreign body implant rejection phenomena and genetic predisposition.