New OTC fertility tests in development
NEW “his and her” fertility tests should be on sale
in the United Kingdom next year. The test kit, known as Fertell, has been
developed by researchers from the University of Birmingham and medical
devices company Genosis.
Presenting details of the male test at the European
Society of Human Reproduction and Embryology meeting in Lausanne, Switzerland,
on July 2, Professor Christopher Barratt of the University of Birmingham
said: “[The test] takes an established technology that is usually employed
in the laboratory and embodies the know-how into a simple to use format
for the lay person.”
The male test measures the concentration of motile
sperm in the semen. After sperm are deposited into a container, a button
is pressed which releases a column of artificial cervical mucus heated
to 37C, reproducing the conditions in a woman’s body. Only motile sperm
are able to swim through the mucus column to a point where they are collected
and tagged with gold-labelled antibodies. They can then be detected on
a nitro-cellulose strip and, if sufficient numbers are present, a red
line will be produced. The number needed to produce such a result will
be greater than 10 million motile sperm per ml (equivalent to the World
Health Organization guideline for normality).
“The current screen for infertility is to try for
12 months and then seek medical advice. But 40 per cent of cases of infertility
are due to male factors and this test can indicate early on if there is
potentially a problem with the man,” Professor Barratt commented.
The Fertell female test differs from current tests
on the market in that it measures follicle stimulating hormone. Current
tests predict ovulation by measuring the rise in luteinising hormone that
occurs before ovulation. Thermometers can be used to measure the rise
in body temperature that occurs as a result of increased progesterone
production after ovulation. Measuring temperature changes over several
months can give an indication of the day of the month a woman ovulates,
rather than to predict ovulation itself.
Prototypes of the two new tests have been tested
in 118 men and 243 women and further clinical trials will take place in
the autumn. The trials will examine how user-friendly the tests are, rather
than their accuracy, which the company says is greater than 95 per cent.
Fertell should be available over the counter in
the first half of next year, depending on regulatory approval. A price
for the test has yet to be decided but Kate Bingham, from Schroder Ventures
Life Sciences (an investor in Genosis) told The Journal she thought
that it would not be more than £100.
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