Gene Predictis increases safety of contraceptive pills

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15.09.2015

Gene Predictis has completed an international clinical validation study for Pill Protect, a test that uses genetic data to identify women at risk of developing blood clots (thrombosis) when using contraceptive pills. The test was shown to identify over 8 times more women at risk than today standard of care, making Pill Protectthe best available test.

Already proposed in Switzerland and reimbursed by the insurances, the Pill Protect helps to identify women at risk of thrombotic disease and facilitate the decision process for medical doctors helping them to propose the most optimal and safest contraceptive pill/method for every woman. Pill Protect estimates the risk of deep vein thrombosis using a proprietary algorithm that takes into account the most important risk factors, including a number of specific genetic, behavioural and environmental factors, together with the constituents of commercially available hormonal contraceptives.

Over 100 million women worldwide make use of oral contraceptives. One of the major challenges for healthcare professionals is to identify women at risk of developing deep vein thrombosis (DVT) related to contraceptive pills, and advice them on alternative contraception methods. Out of about 350'000 women who use contraceptive pills in Switzerland, over 400 annually report the occurrence of thrombosis, sometimes with dramatic effects. In Europe, an estimated 22'000 cases occur each year, incurring an estimated rough amount over Euros 200 millions per year to the healthcare system, dedicated to the treatment of acute complications only.

Gene Predictis Biotech Company validated Pill Protect in a retrospective study that included over 1'600 women using contraceptive pills. A population of 800 women who developed thrombosis related to contraceptive pills’ use, and 800 women controls using contraceptive pills but did not develop the disease were enrolled in the study. The test was shown to correctly identify over 8 times more women who developed thrombosis than the current standard of care (medical questionnaire based on age, behavioural risk factors, personal and familial history).

Altogether, these results brought evidence that Pill Protect® had, as of today, the highest predictive power to identify women at risk of developing deep vein thrombosis related to contraceptive pill use.

Eventually, for the first time, the tool Pill Protect conveyed to physicians the ability to prescribe oral contraceptives making use of scientifically sound arguments to back up risks and advantages.

“This is a fantastic breakthrough in women’s care”, advocates T.D. Pache, MD, PhD, a Swiss gynaecologist, president of the board at Gene Predictis. “Above 5% of women carry gene mutations that expose them to deep vein thrombosis, such a risk is manifold multiplied under oral contraception, not to mention environmental and behavioural that may increase risks on the top of that. To the light of the dramatic complications under contraception widely reported in the media, it was obvious that there was a major need for a tool to prescribe pills taking the safest side”. “In this respect, Pill Protect is amongst the most welcome tests a gynaecologist may dream of, that dream has become a reality”, adds Dr Pache.

(Press release)

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