14-N Correlation between a new method for the detection of reproductive hormones in saliva and a reference method (ELISA or LC-MS/MS).


Women’s contraceptive needs have evolved. In 2016, 51% of Canadian women using hormonal contraception reported adverse effects [1]. There is increasing concern about these adverse effects [1], resulting in a growing number of women seeking hormone-free and non-invasive options. Unfortunately, the innovations to address those needs have not followed. As a result, more and more women are opting for less reliable methods of contraception to avoid side effects [1]. Contraceptive pill use has decreased from 39% in 2006 to 15.7% in 2016 in some age groups, and a quarter of women who have stopped using hormonal contraception have switched to the withdrawal method (80% effectiveness) or are no longer using any method [1]. This contributes to the fact that the number of unintended pregnancies has not decreased over the past 10 years [1], even though highly effective methods are available on the market [1]. There is a clear need for the creation of methods that are highly effective, hormone-free, and non-invasive. Paradoxically, after years of using a contraceptive method for many years, a lot of women learn later in life that it is not so easy to conceive a child. In Canada, 1 in 6 couples experience difficulties [2]. This number has doubled since the 1980s and continues to grow [2]. Trying to conceive a child or avoiding pregnancy are two opposite goals. However, their success depends on the same biological process: the fluctuation of the reproductive hormones that regulate the menstrual cycle and ovulation. Eli’s desire to provide an uncompromising solution for women has led the company to innovate and develop a new technological solution in collaboration with its partners. It is a device that measures reproductive hormones in saliva and a mobile application that will use algorithms to interpret the data and accurately indicate the user’s fertility window. The device has two distinct components: a single-use cartridge that collects and sends saliva to the biosensors (the biosensors are integrated into the cartridge and consist of a layer of aptamer combined with two layers of gold with a shrinkable polymer between them) [3], and an optical measuring instrument. This solution can be used both by couples trying to conceive and as a method of contraception. Eli wants to commercialize the product, firstly to help couples conceive in order to get to the market more quickly, and this requires clinical validation. Following these validations, the product can be registered with regulatory authorities as a Class I medical device. In a second phase (which will take place after the project submitted in this application), Eli wants to commercialize the product as a method of contraception. As the associated risks are higher (unwanted pregnancy), the classification changes for this use case and the product will have to be approved as a Class II medical device. It should be noted that currently only one competitor has regulatory approval in the United States for contraceptive use. It is the company Natural Cycles (which uses temperature as a biomarker in combination with machine learning algorithms) that has created a new regulatory class at the FDA following a request for De Novo classification. This is positive for Eli, as it will most likely speed up the process for the company in the US. It also shows that U.S. regulatory authorities view this type of product favorably, and the FDA has issued a press release acknowledging that this type of product meets an important need [6]. Commercialization of the technology would, therefore, come at an opportune time at the regulatory level, to meet a growing need and in a booming market. The main objective of the project is to validate the reliability of the technology component by comparing it to a gold standard. The secondary objective is to create a dataset of daily levels of reproductive hormone concentration in saliva over complete menstrual cycles.