What was the problem?
Before the 1980s, it took a visit to the GP for most women to confirm their pregnancy. Only laboratory assays could check for an increase in the hCG hormone indicating pregnancy, leaving women beholden to family doctors to find out if they were to have a baby.
The effect of this was to take control of their pregnancy out of the woman’s hands and put it in the hands of a (potentially unsympathetic) third party.
At-home pregnancy tests did exist, but were unpopular because they comprised several steps, took two hours to find out the result, were delicate to perform.
The invention of the first one-step pregnancy test, by a team including Mologic co-founder Paul Davis, can fairly be described as a revolution in women’s health.
In 1984 the first in-home ELISA dipstick from Unipath became popular, based on a three-step ‘chemistry set’ that required 30 minutes and three user interventions to deliver the result.
Although this was an improvement on the previous two-hour delay, the goal was to develop a simple one-step test, establishing a soluble biomarker for clinical diagnosis of pregnancy. It had to enable early detection and be straightforward to carry out, so the worman could perform the test herself, in the privacy of her home and without medical assistance.
A pivotal patent family (Davis & Porter, 1980; May, Prior & Richards 1986 and Davis, May & Prior, 1989) was established covering a double monoclonal sandwich immunoassay.
This breakthrough, from a team including Mologic’s co-founder, Paul Davis, signified the development of a true one-step pregnancy test. Clearblue, which launched in 1988, was the first to transfer control of a pregnancy, from the very beginning, from the medical profession to the mother.
The development of the technology behind Clearblue proved that measuring protein biomarkers can determine the status of a clinical condition.
Clearblue heralded the foundation of the rapid point-of-care diagnostic industry – expected to be worth over $38 billion (nearly £30 billion) by 2022. It was the first diagnostic to excite the women’s healthcare market, putting care in the hands of users, and established an expectation of further ‘one-step’ diagnostic tests in many other markets.
“I never thought testing for pregnancy could be this simple.”