Unipath Ltd was a pharmaceutical company, subsidiary to Unilever and then Alere, specialising mainly in medical diagnostic kits related to women's reproductive health. It subsequently diversified its product range to include more specialised test kits, primarily for the clinical market, in areas other than women's reproductive healthcare.
Based in Bedford, United Kingdom, the company had between 500 and 600 employees globally. Unipath's main assets were folded into Swiss Precision Diagnostics.
Unipath was formed in 1984 by the Unilever group. In 1985 they released and started to manufacture the first in their line of home pregnancy test kits marketed under the Clearblue brand. [1] The name is related to the fact that the test produced a blue marker line as a positive (pregnant) result and that it is 'clear' and simple to use. The product was a success, in part due to intensive advertising and held a majority market share in the UK by the end of the year.
Unipath released their clearplan home ovulation kit in 1987. The kit was designed for use in identifying the period of peak fertility in a prospective mother's menstrual cycle so that the optimal time for insemination leading to conception could be determined. In 1996 Unipath released a complementary product, the Persona fertility monitor, designed to identify fertile and infertile periods in the menstrual cycle. Identification of fertile and infertile days is known as fertility awareness, and may be used as birth control or to help achieve pregnancy.
Unipath continued to make improvements to its fertility-related products over the years, improving their convenience and reliability of use. Refinements included a urine collector strip on their Clearblue pregnancy test that turns pink to indicate proper urine absorption, thus reducing the chance of a false-negative test by improper use. A later refinement also replacing the simple blue line indicator with an LCD display that clearly indicates the result, reducing the chance of the test line being misinterpreted by people unaccustomed to using medical test kits.
In 2001 Unilever sold the company to the Alere (then Inverness Medical Innovations Group). The company has since diversified its products considerably, offering a greater range of test kits for strictly clinical usage. These include tests for Respiratory syncytial virus, Hepatitis B and chlamydia infections, as well as blood chemistry test kits designed to aid diagnosis of myocardial infarction and deep vein thrombosis. Most of these tests employ adaptions of unipath's in-house developed technology and patents thereof. In part, the diversification of the company's range of products in recent years is in anticipation of its original patents expiring, opening it to competition from companies that may use the same technology. In 1994, Unipath released its own range of vitamin supplements for both pregnant and breastfeeding women, released under the Clearblue brand in synergy with its successful pregnancy test kit.
In 2007, Clearblue and other brands were folded into Swiss Precision Diagnostics (SPD) as a 50/50 joint venture between Alere and Procter & Gamble. The Unipath subsidiary was subsequently phased out by Alere. The Bedford main office of the former Unipath operates as a part of SPD under the name Clearblue Innovation Centre.
Fertility awareness (FA) refers to a set of practices used to determine the fertile and infertile phases of a woman's menstrual cycle. Fertility awareness methods may be used to avoid pregnancy, to achieve pregnancy, or as a way to monitor gynecological health.
Calendar-based methods are various methods of estimating a woman's likelihood of fertility, based on a record of the length of previous menstrual cycles. Various methods are known as the Knaus–Ogino method and the rhythm method. The standard days method is also considered a calendar-based method, because when using it, a woman tracks the days of her menstrual cycle without observing her physical fertility signs. The standard days method is based on a fixed formula taking into consideration the timing of ovulation, the functional life of the sperm and the ovum, and the resulting likelihood of pregnancy on particular days of the menstrual cycle. These methods may be used to achieve pregnancy by timing unprotected intercourse for days identified as fertile, or to avoid pregnancy by avoiding unprotected intercourse during fertile days.
Ovulation is the release of eggs from the ovaries. In women, this event occurs when the ovarian follicles rupture and release the secondary oocyte ovarian cells. After ovulation, during the luteal phase, the egg will be available to be fertilized by sperm. In addition, the uterine lining (endometrium) is thickened to be able to receive a fertilized egg. If no conception occurs, the uterine lining as well as the egg will be shed during menstruation.
Infertility is the inability of an animal or plant to reproduce by natural means. It is usually not the natural state of a healthy adult, except notably among certain eusocial species. It is the normal state of a human child or other young offspring, because they have not undergone puberty, which is the body's start of reproductive capacity.
Luteinizing hormone is a hormone produced by gonadotropic cells in the anterior pituitary gland. The production of LH is regulated by gonadotropin-releasing hormone (GnRH) from the hypothalamus. In females, an acute rise of LH known as an LH surge, triggers ovulation and development of the corpus luteum. In males, where LH had also been called interstitial cell–stimulating hormone (ICSH), it stimulates Leydig cell production of testosterone. It acts synergistically with follicle-stimulating hormone (FSH).
Human chorionic gonadotropin (hCG) is a hormone for the maternal recognition of pregnancy produced by trophoblast cells that are surrounding a growing embryo, which eventually forms the placenta after implantation. The presence of hCG is detected in some pregnancy tests. Some cancerous tumors produce this hormone; therefore, elevated levels measured when the patient is not pregnant may lead to a cancer diagnosis and, if high enough, paraneoplastic syndromes, however, it is not known whether this production is a contributing cause, or an effect of carcinogenesis. The pituitary analog of hCG, known as luteinizing hormone (LH), is produced in the pituitary gland of males and females of all ages.
A pregnancy test is used to determine whether a female is pregnant or not. The two primary methods are testing for the female pregnancy hormone in blood or urine using a pregnancy test kit, and scanning with ultrasonography. Testing blood for hCG results in the earliest detection of pregnancy. Almost all pregnant women will have a positive urine pregnancy test one week after the first day of a missed menstrual period.
Abbott Laboratories is an American multinational medical devices and health care company with headquarters in Abbott Park, Illinois, United States. The company was founded by Chicago physician Wallace Calvin Abbott in 1888 to formulate known drugs; today, it sells medical devices, diagnostics, branded generic medicines and nutritional products. It split off its research-based pharmaceuticals business into AbbVie in 2013.
Anovulation is when the ovaries do not release an oocyte during a menstrual cycle. Therefore, ovulation does not take place. However, a woman who does not ovulate at each menstrual cycle is not necessarily going through menopause. Chronic anovulation is a common cause of infertility.
Fertility medications, also known as fertility drugs, are medications which enhance reproductive fertility. For women, fertility medication is used to stimulate follicle development of the ovary. There are very few fertility medication options available for men.
Ovulation induction is the stimulation of ovulation by medication. It is usually used in the sense of stimulation of the development of ovarian follicles to reverse anovulation or oligoovulation.
Poor ovarian reserve is a condition of low fertility characterized by 1): low numbers of remaining oocytes in the ovaries or 2) possibly impaired preantral oocyte development or recruitment. Recent research suggests that premature ovarian aging and premature ovarian failure may represent a continuum of premature ovarian senescence. It is usually accompanied by high FSH levels.
Pregnancy rate is the success rate for getting pregnant. It is the percentage of all attempts that leads to pregnancy, with attempts generally referring to menstrual cycles where insemination or any artificial equivalent is used, which may be simple artificial insemination (AI) or AI with additional in vitro fertilization (IVF).
A conception device is a medical device which is used to assist in the achievement of a pregnancy, often, but not always, by means other than sexual intercourse. This article deals exclusively with conception devices for human reproduction.
Fertility testing is the process by which fertility is assessed, both generally and also to find the "fertile window" in the menstrual cycle. General health affects fertility, and STI testing is an important related field.
Infertility in polycystic ovary disease (PCOS) is a hormonal imbalance in women that is thought to be one of the leading causes of female infertility. Polycystic ovary syndrome causes more than 75% of cases of anovulatory infertility.
Clearblue is a brand of Swiss Precision Diagnostics that offers consumer home diagnostic products such as pregnancy tests, ovulation tests and fertility monitors.
James Boyer Brown MSc (NZ) PhD (Edin) DSc (Edin) FRACOG, Professor Emeritus, Department of Obstetrics and Gynaecology, University of Melbourne.
Alere Inc. was a global manufacturer of rapid point-of-care diagnostic tests. The company was founded in 1991 and was headquartered in Waltham, Massachusetts. As of January 2017, the company had a market capitalization of $3.47 billion with an enterprise value of $5.9 billion. The company was formerly known as Inverness Medical Innovations, Inc. and changed its name to Alere Inc. in 2010.
Swiss Precision Diagnostics GmbH is a Swiss medical diagnostic company, that produces Clearblue-branded pregnancy testing equipment.