Every little gene helps. What the future holds in store for Ukrainian DNA tests abroad

Myhelix

Ukrainian startup Myhelix, that provides personal recommendations as to the nutrition based on genome analysis, gears up for world expansion. Innovation House found out what challenges may face Ukrainians in the world “amused” with genetic tests.

In late summer Ukrainian startup Myhelix introduced nutrient test “My Care”, with which it is going to come into the markets of other countries.

The test analyzes 40 gene variants for the tendency to celiac disease (negative reaction to gluten) and to being low on vitamin D, tendency to dairy products intolerance and to low-density and high-density fats accumulation. Moreover, it also analyzes how the body absorbs vitamin E, and whether it has tendency to enhanced concentration of homocysteine – amino acid that is accumulated with the increase of years and is the marker of various disorders. For instance, disease establishment risk, Alzheimer’s disease, senile dementia, atherosclerosis, and thrombosis.

The test itself is a small box with the container for material collection. You shall place saliva sample in it and, as prescribed by the instruction, send it via “Nova Poshta” (postal operator). Instruction contains unique code that shall be registered by you on Myhelix website. Test results will be available in user’s Dashboard on the website within 20 business days.

DNA analysis is conducted by Finnish laboratory Woble Helsinki, with which Myhelix entered into a contract.

Bioinformaticians handle the genetic data catalog called Genome Wide Association Studies (GWAS Catalog).

In addition to the result of molecular-laboratory analysis of genes, users are advised as to the nutrition and lifestyle, namely: the list of products in accordance with the variants of the genes, examples of different dishes from these products for each day, advices of dieticians considering the age and physical activity level of customer.

Three versions of test are available: for men, for women and for children. Its costs 6,500 UAH (approx. $250).

Expansion beginning

When the new test was introduced, Myhelix started to prepare for global expansion and connection establishment. Daria Loseva, founder of Myhelix startup, in her interview to Innovation House told that negotiations with potential partners that may sell “My Care” test in Czech Republic and Germany are currently in progress. Though there are no executed partnership agreements with them yet. “For now, we are studying some aspects of doing business there and drafting partners selection criteria,” – said Daria Loseva.

Founders of Myhelix Ruslana Shadrina, Daria Loseva, Oleksandra Alokhina with project investor Gennadiy Kurochka

Founders of Myhelix Ruslana Shadrina, Daria Loseva, Oleksandra Alokhina with project investor Gennadiy Kurochka

In late September Myhelix, will be among 15 projects from Ukraine, who will go to San Francisco for the largest startups conference TechCrunch Disrupt, where they plan to establish contacts. Myhelix team hopes to meet investors and foundations investing in biotech startups – project at the confluence of biology, chemistry and engineering. Meeting with such scientific representatives of other genetic services and companies, as 23andme, Color, Grail, are being planned. “Like any other startup participating in this conference, we want to get acquainted with highest possible number of persons. We have already decided that every day we will give 50 business cards or more,” – said Daria Loseva.

At the same time, Christina Shevchenko, Myhelix dietician will participate in the scientific conference on nutrigenetics 11th Congress of the International Society of Nutrigenetics and Nutrigenomics. “Purpose of the trip is to learn more about the possibilities of DNA test services in USA, to get deeper into the knowledge of nutrigenetics, to get as much as possible feedbacks about the project, to tell about ourselves,” – explained Daria Loseva.

There were others

Myhelix is ​​not the first DNA test having Ukrainian origin that tried to work on the world market. In early 2015, Ukrainian scientist, Candidate of Chemical Sciences, Alexander Savsunenko together with his business partner Corey McCarren established Titanovo company in the U.S. It dealt with telomere (DNA sections that show how body cells got old) length research. In addition to genetic analysis, Titanovo provided recommendations: what person shall do and what meals to take in order to prolong the life.

Myhelix

In the middle of 2015, Alexander Savsunenko even opened the company under the same name in Ukraine.

This company dealt with researches here. But in less than a year Alexander was forced to wind it up: Ukrainians were not ready for such kind of product. Titanovo focused its efforts on American market, but in summer of 2017 work there was placed on hold. According to Savsunenko’s post in Facebook, company received the legal claim as to patent law infringement, and this struggle turned to be extremely costly affair. “Some time of stress and court proceedings has to be spent, 3 years of work are lost, the new product is not launched,” – he wrote at the time. Some time later post was deleted, and Alexander Savsunenko could not give additional comments in this regard to Innovation House.

According to Alexander Kolyada, Research Officer of the Institute of Gerontology of the National Academy of Medical Sciences of Ukraine, who cooperated with Titanovo and Myhelix founders, Ukrainian-American project had a large variety of difficulties. “Such difficulties related to logistics (biomaterials sending), non-medical advising – these moments are very strictly controlled in the USA. Severe problem arose with the intellectual property rights for some technologies used as well. Due to this, one of the field of company’s work had to be suspended,” – explained Alexander Kolyada. According to him, most of the difficulties appeared when Titanovo stopped its cooperation with Ukrainian scientists, ceased to invest heavily in scientific developments of new products, and focused exclusively in business processes. “Currently company is developing new products that also have relevance to personalization,” – he said.

Alexander Kolyada believes that several key points shall be admitted if you start doing business in the field of biomedicine. “World’s homeopathy and phytotherapy market is vast, in spite of the lack of direct benefits from most of the products. But when you sell something, you shall know for sure whether it works or no, and in which case. This will help to make proper product positioning,” – explained he.

The second point is proprietary rights. You shall keep track of them: uphold own right and not to infringe the rights of others. Patent experts and lawyers help in this matter.

“Miracle cure” effect

Consumer DNA tests are the promising worldwide market.

According to various estimates by 2022 its volume may exceed $300 mln. Such tests are top requested in UK, the USA, Canada and countries of Northern Europe – where people proactively monitor their health and are ready to pay for it.

However, DNA tests are not always linked to health care field.

The most famous world players – British company AncestryDNA and American 23andme – offer their customers to find out their origin and ethnic background based on genetic analysis.

In the internet you may also find expressly fraudulent companies offering their customers “to know all the truth about themselves using DNA”, “to find soulmate using DNA” or to check compatibility with your pet “at the genetic level”. This makes the man in the street fall under the impression that DNA test – is a “miracle cure” able to fix all the problems. But, it doesn’t work that way. Genetic diagnosis and results decoding is much more complicated. And therefore, consumer DNA tests frequently make genetic doctors feel skeptically.

According to Dmytro Mykytenko, Laboratory Head at Kyiv city Clinic “Nadiya”, Candidate of Medical Science, Genetic Doctor, genetic tests may give us enormous aggregation of health-promoting information if they are properly interpreted.

Up-to-date equipment allows us to decode up to 20 thousand of human genes at a time.

And genetic diagnosis itself is extremely precise. But the main problem is to define clinical relevance of genetic polymorphism – mutation changing activity of gene afterproduct. For this genetic variant to be developed into disease, combination with certain specific external or internal risk factors is needed. In other words, availability alone of genetic disposition to pathology makes it impossible to give findings on presence of disease. “We shall collect medical case history, study family history, lifestyle, conduct range of general clinical researches, be aware of polymorphism expansion frequency in this region and its clinical significance,” – explained he.

Medical tests conducted by him in clinic allow you to make specific diagnosis and define quantitative risks. For instance, percentage probability that parents-carriers of any genetic disease will give birth to sick child. In most of the cases blood is sampled to conduct the analysis, as it makes it capable of giving sufficient amount of high quality genetic material.

Most of the consumer tests determine liability to disease rather than its presence.

Moreover, even the quantitative risk assessment of its occurrence is not calculated. On frequent occasions this is simply impossible. At the same time, general recommendations are given based on sample analysis with no collection of important information about the state of health of the patient, his medical and family history. “In a nutshell, advises of 99% of these tests come to the same thing: if you lead a healthy life you will live longer. And broadly speaking this is good. – Dmytro Mykytenko said. – Problems arise when, for instance, the patient has coexistent diseases (and he may even be unaware of them). Then, advised specific diet or lifestyle, plucked out of the air, may contradict the medical evidence and may significantly worsen the state of health.”

Dmytro Mykytenko

Dmytro Mykytenko

Not medicine, but lifestyle

According to Dmytro Mykytenko it is important to get message across to the consumer that such tests are not medical. It is the doctor, who during the face-to-face advising may render qualified judgement as to such sort of tests, and may apprise whether it is acceptable to follow recommendations stated in these tests. Major sellers of consumer DNA tests already wrote this in the results that are sent to the customer. Another question is how strictly customers adhere to this warning and whether they turn to doctor afterwards.

Daria Loseva from Myhelix told the story when one of the customers found out that she had liability to cholesterol accumulation. She turned to the doctor, conducted lipid profile, and being not overweight her cholesterol level was elevated.

But, once again, it was doctor, who gave medical opinion, not the startup itself.

Some time ago, determination of nature of pieces of advice was stumbling stone for 23andme company in the USA. FDA made it stop selling its medical tests.

As a result, 23andme switched to ethnic background analysis.

In April 2017, FDA allowed startup to sell its tests that determine the genetic diseases development risk. But subject to reservations: the test cannot be used to diagnose or make decisions as to the treatment. But it may be shown to medical experts, or decision to change lifestyle may be made based on it. In addition to the above, 23andme continues its own genetic researches. For instance, in cooperation with German pharmaceutical company Grünenthal it studies the genetics link with the tolerability of pain to develop “anesthesia of the future”.

According to Alexander Kolyada, scientific researches, as well as availability of own material and technical basis, are of paramount importance for the genetics field startups. This is compulsory minimum and without it product will not be modernized, put to tests, and new product will not be developed too.