Q&A: The thinking behind developing a self-test fertility platform
Ian Bolland spoke to Concepta Diagnostics chairman and CEO Matthew Walls whose company have developed myLotus, an app and device self-test platform to allow women to identify their optimal fertile days.
Tell us about where the idea came from for myLotus?
The original idea came from a conversation between one of the company founders who was an expert in fertility lamenting on the lack of availability of more precise fertility products. The view being that if we could supply a fertility product with a more precise fertility window we would sell significant numbers. The conversation led to checking the technical feasibility of making improvements to standard ovulation products, developing a prototype and setting up Concepta.
In what way is such technology ‘transforming’ the way we approach fertility?
The technology was secondary to the women’s needs. The complexity of all the parameters that have to come together in each cycle to create ideal conditions for conception means that going through the doctors’ route only covers some clear clinical reasons for infertility. Not all the reasons are about detection and treatment. A lot is about understanding how the body works, what balance is required, what causes an imbalance and what is in the woman’s power to prevent. myLotus is at the forefront of personalised healthcare. This means that we make it possible for the woman to measure and track what happens in her body. This learning results in a better understanding of what is your personal “normal”. It shows you when you are deviating from your normal and also whether your interventions (medicine, diet, exercise, etc) bring you back to normal. All this without frequent visits to doctors or hospitals where a blood test may be required and this blood test will just be a snapshot of your condition on that day. For fertility myLotus allows women to see when their fertile days are and for the large group for whom pregnancy does not come as quickly as expected it provides information on whether ovulatory aspects may contribute to the delay. The knowledge gained could help these women speed up their time to a natural pregnancy.
Give us an idea of the technology that has gone into making myLotus possible?
We knew that, to make it possible to personalise the results to each individual woman, we needed to be able to show the both quantitative results and the ‘rate-of-change’ in these test results over time. Classic ovulation tests are based on a certain level for the “average” woman. When you are above or below that line you are positive or negative. Too many women deviate from these average values for standard tests to be useful for all women. At the same time women have been used to urine home tests for over 30 years so we didn’t want to change that practice too much. We focused on developing a monitor that could convert the strength of the results it detects in these classic test strips into a result that it displays on its monitor and app. Barcode technology provides the monitor with information on how to do this. We test each batch of test strips against clinical analysers to ensure that the monitor gives accurate readings for any batch and without the need for calibration.
How long did it take to develop the product? Did it take some time before 100% of the ovulation tests correlated with hospital blood tests?
The product was in development, validation and registration for the best part of five years. This included lab tests against clinical analysers, user trials and hospital trials against blood tests. Each manufacturer of diagnostic tests has different components so, when tested against each other they will produce different absolute numbers. For LH correlation you look at how well the hormone profiles mirror each other. myLotus was proven to be excellent for this.
What anomalies does it pick up that other ovulation tests do not?
myLotus has a number of benefits over classic ovulation tests:
A) Everyone has a starting level (baseline) of the LH hormone. If yours is very high the classic tests could always give you a positive. If it is very low and your surge is small you may never see a positive.Research shows that only 44% of women fit the “average” hormonal profile so the women that are most likely to need accurate results of their LH surge to find out their fertile days are unlikely to be helped with classic ovulation tests.
B) Classic ovulation tests focus on detecting the LH surge. This does not take into account that one in five women will have more than one surge with research showing that in many cases ovulation does not happen after the first surge but the second. myLotus measure the rate-of-change in hormone levels over time providing a ‘signature’ of a women’s cycle profile.
C) Research is linking the hormonal profile to probability of conception. myLotus would show whether you are in that ideal profile or not. This knowledge helps with hints at whether ovulatory issues could be a cause of delay to your time to conception.
D) The monitor and the app store data to allow you to compare many cycles and keep accurate track of cycle length and any regularity or irregularity (e.g. I always see the surge on day… of my cycle). The fact that the date and time and the actual values are stored, combined with doing a myLotus pregnancy test at the earliest possibility means that, when you do get pregnant, the doctor has all the information required to accurately determine what stage of the pregnancy you are at and what the due date is. This could be important for the subsequent management of the pregnancy.
What is part of myLotus that allows it to pick up such anomalies?
The uniqueness of myLotus is based on developing a system that allows you to ‘self-test’ and monitor your personal hormone levels. On top of this we pull together the very detailed scientific studies that have shown what can happen in the body and how this affects fertility. We translate this in useful applications for myLotus. Whilst this research has been of academic interest in the past it is now possible for women to get the useful insights themselves thanks to myLotus.
The beauty of myLotus is that the platform technology can be applied to a number of tests and conditions. Whether we think of fertility, chronic disease management or companion diagnostics. The link with the app allows the possibility of remote patient management, eliminating the need for large numbers of hospital visits. When monitoring personalised levels users can set triggers that allow timely doctor intervention as soon as levels go outside your normal parameters. The list of opportunities is endless.
Are there any future plans for myLotus?
Our initial focus is to strengthen our portfolio in the fertility area, including progesterone, Oestrogen and Follicle Stimulating Hormone. This will extend the use of myLotus to infertility clinics and will also address additional aspects of fertility for the home users. For fertility and menstrual cycle assessment we will provide women with the most comprehensive set of self-tests for home monitoring. Users will be able to monitor the rate-of-change of each hormonal aspect to understand and optimise their window on fertility and increase their chances of a natural conception.