A Malta-developed vaginal microbiome test promising to detect all infections in a single swab – including HPV, Candida, parasites and STIs – is set to be available locally, following three years of research and trials.  

Created and produced in San Ġwann laboratory BioArte, the test provides a snapshot of a woman’s vaginal microenvironment.

Microbiologist and nutritionist Manuele Biazzo, who is BioArte’s scientific director and CEO, said the test aims to help women understand their “microbial self” and make changes if the balance is disrupted. 

Issues like infertility, recurrent infection or pre-menopausal disorders can be helped by altering the microbiome, he said.

The test has been carried out in the lab’s satellite companies in Greece and Italy for a year now, but this is its first rollout in Malta, where it will be available in selected chemists for between €250 and €300. 

“Many tests are outsourced because of a lack of technology or an insufficient volume of samples to justify the complex machinery. But this one is all done here, including the bioinformatics software, which has been produced and installed in Malta,” he said.

Microbiologist Manuele BiazzoMicrobiologist Manuele Biazzo

The women’s microbiome swab “allows you to see everything” – from the human papillomavirus (HPV) to parasites and Candida – instead of checking for each one individually and ramping up the costs. It picks up on all pathogens, whether a virus, bacteria or fungus, and catches all sexually transmitted infections (STIs), Biazzo explained.

Normally, these infections would be identified through separate tests, which isolate and grow bacteria. 

But Biazzo says the new test conducts a genetic analysis, extracting the DNA sequence with next-generation technology, decoding all the information to understand whether it belongs to a virus, bacteria, parasite, or fungus.

Biazzo is enthusiastic about the test’s ability to assess the overall vaginal and gut ecosystem and help tackle various women’s health issues. This can be achieved by rebalancing it, possibly through the right diet and personalised probiotic treatment, he said.

Many suffer from recurrent cystitis, for example, and undergo antibiotic treatment. But often it is the environment that is not right for protection and this is what needs to be treated, Biazzo explained. 

These patients need to balance the microbial population, otherwise they will be taking antibiotics regularly.

In menopause, hormonal changes can drive the disbalance of the microbiome.

If this is fully populated by lactobacilli, which produce lactic acid, an acidic environment is created, preventing any fungus from growing. But if there are not enough lactobacilli, the pH is changed, giving other pathogens the opportunity to proliferate.

“Candida is not contracted from using a dirty toilet at an airport. It is an intestinal fungus that we all have,” said Biazzo. “But if the pH is not right and the microbiome is disbalanced, it can grow.”

In the case of pregnancy, success – in particular when it comes to IVF – is also linked to the microbiome, he said. If there is inflammation, it is difficult for the embryo to implant and start cell division.

“This is not just about determining whether you have Candida, or HPV, or not – it is about how much of it. Results reflect the percentage abundance of microorganisms present. If it is very high, you need to be worried. Antibiotics are prescribed, but sometimes, a simple change in diet can solve the situation.”

Gynaecologists are not properly trained on new microbiome test

Asked why such a test was not yet more widespread, Biazzo explained the concept of the microbiome was still relatively new and gynaecologists were not properly trained on it.

Now, for the first time, it will be introduced in a local pharmacy chain in the coming weeks, but Biazzo wants to carry out information sessions for gynaecologists too. 

He believed it should be used as routine screening – like a blood test – to check and discover anything and everything and change habits. 

The swab can be carried out by patients themselves, but Biazzo acknowledged the limitations of this, and the cultural change needed for them to check themselves out.

“When it comes to prevention and routine check-ups, it can be done alone. But if there is an issue, patients should go to a gynae to undergo the test.”