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Owner | SPD Swiss Precision Diagnostics GmbH |
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Introduced | 1985 |
Markets | World |
Website | www |
Clearblue is a brand of Swiss Precision Diagnostics that offers consumer home diagnostic products such as pregnancy tests, ovulation tests and fertility monitors. [1] [2] [3]
Clearblue was introduced in 1985 with the launch of the first Clearblue Home Pregnancy Test system, which at the time was owned by Unilever. [4] It was the world’s first “rapid home test” that gave pregnancy test results in 30 minutes and allowed a woman to take a test before going to the doctor. [4] The test was a three-step process using a dipstick and small tray. [4]
In 1988, Clearblue launched the first one-step pregnancy test with the invention of lateral flow technology. [3] [5] This one-step test gave a result in 3 minutes, subsequently reduced to a 1-minute result when Clearblue introduced the world’s first one-minute home pregnancy test in 1996. [6] In 2003, Clearblue released the first digital pregnancy test to show the result in words ‘Pregnant’ or ‘Not Pregnant’ on a digital screen. [7] [8]
In 2008, Clearblue launched the Clearblue Digital Pregnancy Test with Conception Indicator, which sells in Europe. [9]
Clearblue has also launched ovulation and fertility home diagnostic products to help women identify their fertile days and to maximize their chances of conception. [10]
In 1989, Clearblue released the first one-step home ovulation test, enabling women to measure their surge in Luteinising Hormone (LH) to determine their most fertile days. [8] [11] In 1999, the brand launched the world’s first dual-hormone fertility monitor, which allowed women to measure estrone3-glucuronide (estrogen) in combination with LH. [12]
The company created the first digital ovulation test in 2004. [13]
In 2013, the company also began offering an ovulation test with a dual hormone read, detecting both estrogen and LH.
In 2017, Clearblue launched the Clearblue® Connected Ovulation Test System. The Clearblue Connected Ovulation Test System connects via Bluetooth® to a users phone – it was the first test system tracking 2 hormones and connecting to the user's phone. Results are synced and displayed on the phone together with a monthly calendar, cycle comparison charts. Users can also set smart reminders.
Clearblue won the 2012 Red Dot Design Award in the product design category for its Clearblue Plus Pregnancy Test. Its ergonomic design aimed to make the test easy to use. [14] The Clearblue Digital Ovulation test was the 2011 Platinum winner in the Prima Baby Reader Awards. [15]
In 2019 Clearblue’s Connected Ovulation Test System won the European New Product of the Year Award by Nicholas Hall, sponsored by OTC New Products Tracker and Most Innovative New OTC Product in the UK OTC Marketing Awards 2019https://pharmaintelligence.informa.com/events/awards/otc-marketing-awards-2019/winners-2019
Clearblue partnered with Tommy’s Charity in the UK in 2018-2019 to promote the importance of preparing for pregnancy. [16]
In 2019, Clearblue, in partnership with the Be My Eyes app, launched the first service of its kind for their blind and low vision users of Clearblue. [17]
Clearblue was a donor to Flight for Every Mother Ltd, a humanitarian project led by Dr. Sophia Webster which aimed to improve maternal health in Africa. [18]
SPD was formed in 2007 as a joint venture, between Procter & Gamble (P&G) and Alere (now a part of the Abbott group, since October 2017) to create, using its parent companies’ complementary strengths, one of the world's foremost organisations in consumer diagnostics. [19]
P&G is a major consumer goods company, with numerous household brands that touch the lives of millions of people every single day. Alere (a wholly owned subsidiary of Abbott) is among the world's leading providers of innovative diagnostic products, renowned for their proven reliability in the professional management of women’s health and chronic and infectious disease
SPD is headquartered in Geneva, Switzerland. [20] In addition to Clearblue, the company also manufactures and distributes other consumer diagnostic products.
The Clearblue research and development facility - the Clearblue Innovation Center - is based in Bedford, United Kingdom, and employs over 150 people. The Research Center has conducted over 180 clinical studies involving over 300,000 clinical trial participants. [21] [22]
Ovulation is the release of egg cells from the ovaries as part of the ovarian cycle for most vertebrates. In women, this event occurs at the end of the follicular phase, when the ovarian follicles rupture and release the secondary oocyte ovarian cells.
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 unknown 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.
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.
Gonadotropins are glycoprotein hormones secreted by gonadotropic cells of the anterior pituitary of vertebrates. This family includes the mammalian hormones follicle-stimulating hormone (FSH) and luteinizing hormone (LH), the placental/chorionic gonadotropins, human chorionic gonadotropin (hCG) and equine chorionic gonadotropin (eCG), as well as at least two forms of fish gonadotropins. These hormones are central to the complex endocrine system that regulates normal growth, sexual development, and reproductive function. LH and FSH are secreted by the anterior pituitary gland, while hCG and eCG are secreted by the placenta in pregnant women and mares, respectively. The gonadotropins act on the gonads, controlling gamete and sex hormone production.
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.
Menotropin is a hormonally active medication for the treatment of fertility disturbances. Frequently the plural is used as the medication is a mixture of gonadotropins. Menotropins are extracted from the urine of postmenopausal women.
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.
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.
Ganirelix acetate, sold under the brand names Orgalutran and Antagon among others, is an injectable competitive gonadotropin-releasing hormone antagonist. It is primarily used in assisted reproduction to control ovulation. The drug works by blocking the action of gonadotropin-releasing hormone (GnRH) upon the pituitary, thus rapidly suppressing the production and action of LH and FSH. Ganirelix is used in fertility treatment to prevent premature ovulation that could result in the harvesting of eggs that are too immature to be used in procedures such as in vitro fertilization.
Controlled ovarian hyperstimulation is a technique used in assisted reproduction involving the use of fertility medications to induce ovulation by multiple ovarian follicles. These multiple follicles can be taken out by oocyte retrieval for use in in vitro fertilisation (IVF), or be given time to ovulate, resulting in superovulation which is the ovulation of a larger-than-normal number of eggs, generally in the sense of at least two. When ovulated follicles are fertilised in vivo, whether by natural or artificial insemination, there is a very high risk of a multiple pregnancy.
Gonadotropin preparations are drugs that mimic the physiological effects of gonadotropins, used therapeutically mainly as fertility medication for ovarian hyperstimulation and ovulation induction. For example, the so-called menotropins consist of LH and FSH extracted from human urine from menopausal women. There are also recombinant variants.
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.
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.
Carl Axel Gemzell was a Swedish medical doctor and pioneer in reproductive endocrinology.
Swiss Precision Diagnostics GmbH is a Swiss medical diagnostic company, that produces Clearblue-branded pregnancy testing equipment.
Gonadotropin surge-attenuating factor (GnSAF) is a nonsteroidal ovarian hormone produced by the granulosa cells of small antral ovarian follicles in females. GnSAF is involved in regulating the secretion of luteinizing hormone (LH) from the anterior pituitary and the ovarian cycle. During the early to mid-follicular phase of the ovarian cycle, GnSAF acts on the anterior pituitary to attenuate LH release, limiting the secretion of LH to only basal levels. At the transition between follicular and luteal phase, GnSAF bioactivity declines sufficiently to permit LH secretion above basal levels, resulting in the mid-cycle LH surge that initiates ovulation. In normally ovulating women, the LH surge only occurs when the oocyte is mature and ready for extrusion. GnSAF bioactivity is responsible for the synchronised, biphasic nature of LH secretion.