Good Start Genetics, Inc., announced the completion of an $18 million Series A financing. The proceeds of this financing will be used to complete the development and launch of the Company's pre-pregnancy genetic test, which utilizes advanced DNA sequencing technology to screen for a panel of genetic disorders including those recommended by the American Congress of Obstetricians and Gynecologists (ACOG) and the American College of Medical Genetics (ACMG). The financing was led by OrbiMed Advisors, Safeguard Scientifics, Inc. (NYSE: SFE) and SV Life Sciences.
"It is our belief that the only way to make these truly important decisions is under the professional guidance of a physician, who can evaluate genetic information in the context of a patient's comprehensive medical profile"
The Company also announced that Don Hardison, former COO of LabCorp and CEO of Exact Sciences, has been appointed President, CEO and Director of the Company. Good Start Genetics' Board of Directors is chaired by Marc Beer, former CEO of ViaCell, and also includes Robert Carpenter, Director of the Genzyme Corporation; Carl Gordon, General Partner at OrbiMed Advisors; Gary Kurtzman, Managing Director at Safeguard Scientifics; and Lutz Giebel, Managing Partner at SV Life Sciences.
Good Start Genetics' advanced DNA sequencing technology is designed to deliver a higher detection rate and improved clinical performance compared to currently available screening methods, such as genotyping and SNP analysis. Higher detection rates provide physicians with more accurate results and more clinically relevant genetic information. The Good Start Genetics test will allow physicians to better identify carriers of heritable genetic disorders, enabling physicians to help prospective parents make more knowledgeable medical decisions. The Company expects to launch its test exclusively through board certified physicians in the U.S. starting in 2011.
"We expect this test to be widely adopted as the new clinical standard of care for pre-pregnancy genetic screening," said Marc Beer, Chairman of the Board of Good Start Genetics. "The diagnostic industry demands tools that provide physicians with highly accurate genetic information that is clinically valuable for individual patients. Under the leadership of Don Hardison, Good Start Genetics has the technology, experience and vision to make this goal a reality."
Unlike other companies, which offer their tests online or direct-to-consumers, Good Start Genetics will offer its test exclusively through board certified physicians in a clinical setting. "It is our belief that the only way to make these truly important decisions is under the professional guidance of a physician, who can evaluate genetic information in the context of a patient's comprehensive medical profile," commented Mr. Hardison. "Good Start Genetics is moving beyond the existing one-size-fits-all genetic testing paradigm because we believe that genetic information is a critical and a completely individual aspect of healthcare. Our product will allow physicians to select from a broad panel of disorders, and customize their test order to meet the individual screening needs of each prospective parent."
Don Hardison is a clinical diagnostic industry leader with over 28 years of management and commercial experience. Prior to joining Good Start Genetics, Mr. Hardison was an Executive Vice President and Chief Operating Officer at Laboratory Corporation of America. Previously, Don served as President and Chief Executive Officer at EXACT Sciences, an applied genomics and biotechnology company focused on the early detection of cancer. He has also held leadership roles at SmithKline Beecham Corporation and Quest Diagnostics.
Good Start Genetics received initial seed financing from the Massachusetts Life Sciences Center's Accelerator Program.
Source:
Good Start Genetics
OrbiMed
Safeguard Scientifics, Inc.
SV Life Sciences
четверг, 29 декабря 2011 г.
четверг, 22 декабря 2011 г.
Body Mass Index: Do You Know Yours?
Add this number to your need-to-know file: your body mass index.
Just like your blood pressure reading or cholesterol level, your body mass index (BMI) has an impact on your risk of many health problems, including heart disease, type 2 diabetes and some cancers. With a lower BMI, you typically have lower blood pressure readings and lower levels of blood sugar and cholesterol.
Mayo Clinic's Warren Thompson, M.D., answers questions about BMI in the February issue of Mayo Clinic Women's HealthSource.
What is it? Body mass index is the most common measure used for defining obesity. You can calculate it by dividing your weight in pounds by height in inches squared and then multiplying this answer by 703. A BMI of 18.5 to 24.9 is considered the healthiest. People with a BMI between 25 and 29.9 are considered overweight. BMI numbers over 30 indicate obesity. If you do not wish to try the calculation yourself, The Calculator Site contains a useful BMI calculator tool.
What about other measures? Both waist circumference and waist-to-hip ratio provide a measure of central obesity. People who have more weight in the abdomen and waist -- central obesity -- seem to have higher risk of obesity-related health problems than those whose weight is concentrated in the buttocks and thighs. Women whose waist-circumference measurement is 35 inches or more may be at greater risk of health problems than are those who have smaller waists.
BMI and these other measures are useful because they provide information that's independent of each other. With a normal BMI, you could still be at increased risk if you had a high waist-circumference measurement. The highest risk is for people with both a high BMI and high waist circumference.
Why should women discuss BMI and other measurements with their doctor? Weight loss can be a touchy subject because some people tend to feel guilty and ashamed about their weight. Objective measures are a starting point for a discussion on weight loss and health goals -- with a focus on looking forward.
Source: Mayo Clinic
Just like your blood pressure reading or cholesterol level, your body mass index (BMI) has an impact on your risk of many health problems, including heart disease, type 2 diabetes and some cancers. With a lower BMI, you typically have lower blood pressure readings and lower levels of blood sugar and cholesterol.
Mayo Clinic's Warren Thompson, M.D., answers questions about BMI in the February issue of Mayo Clinic Women's HealthSource.
What is it? Body mass index is the most common measure used for defining obesity. You can calculate it by dividing your weight in pounds by height in inches squared and then multiplying this answer by 703. A BMI of 18.5 to 24.9 is considered the healthiest. People with a BMI between 25 and 29.9 are considered overweight. BMI numbers over 30 indicate obesity. If you do not wish to try the calculation yourself, The Calculator Site contains a useful BMI calculator tool.
What about other measures? Both waist circumference and waist-to-hip ratio provide a measure of central obesity. People who have more weight in the abdomen and waist -- central obesity -- seem to have higher risk of obesity-related health problems than those whose weight is concentrated in the buttocks and thighs. Women whose waist-circumference measurement is 35 inches or more may be at greater risk of health problems than are those who have smaller waists.
BMI and these other measures are useful because they provide information that's independent of each other. With a normal BMI, you could still be at increased risk if you had a high waist-circumference measurement. The highest risk is for people with both a high BMI and high waist circumference.
Why should women discuss BMI and other measurements with their doctor? Weight loss can be a touchy subject because some people tend to feel guilty and ashamed about their weight. Objective measures are a starting point for a discussion on weight loss and health goals -- with a focus on looking forward.
Source: Mayo Clinic
четверг, 15 декабря 2011 г.
Differentiating Interstitial Cystitis From Similar Conditions Commonly Seen In Gynecologic Practice
UroToday - Symptoms characteristic of IC have been reported to occur in more than 2% of women. Far more common conditions can result in confounding symptomatology. Dr. Jeffrey Dell and colleagues from Knoxville, Tennessee and New Brunswick, NJ remind us of some of these more common disorders.
Urinary tract infections (UTI) are very common among women. Over half of all women will experience a urinary tract infection during their lifetimes. Many BPS/IC patients are mistakenly diagnosed with recurrent UTI, and the importance of documenting the presence of true infection in patients with dysuria and frequency is self-evident if one does not want to miscategorize and mistreat this group of patients.
Endometriosis, the presence of endometrial glands and stroma outside the uterus, is a common gynecological condition occurring in up to 50% of premenopausal women and in 71-87% of women with chronic pelvic pain. Patients with endometriosis may present with chronic pelvic pain in addition to urinary frequency, dysuria, and hematuria, particularly if the bladder wall is involved. Dyspareunia is another common symptom. The pain of endometriosis is typically cyclical. The diagnosis is based on history, physical examination, laparoscopic examination, and confirmation by histology.
Chronic pelvic pain (CPP) is generally defined as pain that 1) localizes to the anatomic pelvis, the anterior abdominal wall at or below the umbilicus, the lumbosacral back, or the buttocks; 2) is of sufficient severity to lead to medical care or functional impairment; 3) lasts for greater than 6 months. Best estimates are that 15-20% of women aged 18-50 years have suffered from CPP. It is truly difficult to differentiate from other disorders,
Vulvodynia is defined as chronic vulvar burning, stinging, or pain in the absence of clear pathology. Limited epidemiologic data suggest a lifetime prevalence of 10-28%. While BPS/IC is often associated with dyspareunia, its association with vulvodynia as defined is somewhat unclear, and the definition of each disorder should clearly help the clinician make the distinction.
Finally, overactive bladder has prevalence up to 10 times that of BPS/IC. It is characterized by urinary urgency with or without urge urinary incontinence and usually with frequency and nocturia in the absence of obvious pathology. The conditions of BPS/IC and overactive bladder may be differentiated by the presence of pain in BPS. Care should be taken to attribute a failure of efficacy of antimuscarinics in suspected overactive bladder to the presence of BPS, as many patients with overactive bladder may not experience significant efficacy with antimuscarinic therapy.
This is a nice article which brings out issues of importance to the clinician involved with the diagnosis of BPS and confounding disorders.
Dell JR, Mokrzycki ML, Jayne CJ
Eur J Obstet Gynecol Reprod Biol. 2009 Jun;144(2):105-9.
doi:10.1016/j.ejogrb.2009.02.050
UroToday Contributing Editor Philip M. Hanno, MD, MPH
UroToday - the only urology website with original content global urology key opinion leaders actively engaged in clinical practice. To access the latest urology news releases from UroToday, go to:
www.urotoday
Copyright © 2009 - UroToday
Urinary tract infections (UTI) are very common among women. Over half of all women will experience a urinary tract infection during their lifetimes. Many BPS/IC patients are mistakenly diagnosed with recurrent UTI, and the importance of documenting the presence of true infection in patients with dysuria and frequency is self-evident if one does not want to miscategorize and mistreat this group of patients.
Endometriosis, the presence of endometrial glands and stroma outside the uterus, is a common gynecological condition occurring in up to 50% of premenopausal women and in 71-87% of women with chronic pelvic pain. Patients with endometriosis may present with chronic pelvic pain in addition to urinary frequency, dysuria, and hematuria, particularly if the bladder wall is involved. Dyspareunia is another common symptom. The pain of endometriosis is typically cyclical. The diagnosis is based on history, physical examination, laparoscopic examination, and confirmation by histology.
Chronic pelvic pain (CPP) is generally defined as pain that 1) localizes to the anatomic pelvis, the anterior abdominal wall at or below the umbilicus, the lumbosacral back, or the buttocks; 2) is of sufficient severity to lead to medical care or functional impairment; 3) lasts for greater than 6 months. Best estimates are that 15-20% of women aged 18-50 years have suffered from CPP. It is truly difficult to differentiate from other disorders,
Vulvodynia is defined as chronic vulvar burning, stinging, or pain in the absence of clear pathology. Limited epidemiologic data suggest a lifetime prevalence of 10-28%. While BPS/IC is often associated with dyspareunia, its association with vulvodynia as defined is somewhat unclear, and the definition of each disorder should clearly help the clinician make the distinction.
Finally, overactive bladder has prevalence up to 10 times that of BPS/IC. It is characterized by urinary urgency with or without urge urinary incontinence and usually with frequency and nocturia in the absence of obvious pathology. The conditions of BPS/IC and overactive bladder may be differentiated by the presence of pain in BPS. Care should be taken to attribute a failure of efficacy of antimuscarinics in suspected overactive bladder to the presence of BPS, as many patients with overactive bladder may not experience significant efficacy with antimuscarinic therapy.
This is a nice article which brings out issues of importance to the clinician involved with the diagnosis of BPS and confounding disorders.
Dell JR, Mokrzycki ML, Jayne CJ
Eur J Obstet Gynecol Reprod Biol. 2009 Jun;144(2):105-9.
doi:10.1016/j.ejogrb.2009.02.050
UroToday Contributing Editor Philip M. Hanno, MD, MPH
UroToday - the only urology website with original content global urology key opinion leaders actively engaged in clinical practice. To access the latest urology news releases from UroToday, go to:
www.urotoday
Copyright © 2009 - UroToday
четверг, 8 декабря 2011 г.
Georgia Bill Would Increase Regulation Of In Vitro Fertilization Procedures
Georgia lawmakers have introduced a bill (S.B. 169) that would place restrictions on the number of embryos that could be implanted in a woman during an in vitro fertilization procedure, the Wall Street Journal reports. The bill "appears to be the most sweeping state legislation of its kind introduced in the wake of the case" of 33-year-old Los Angeles resident Nadya Suleman who gave birth to octuplets via IVF, the Journal reports. The bill, which is scheduled for a legislative hearing this week, would limit the number of embryos that may be implanted in women age 40 and older to three and limit the number to two for women ages 39 and younger. The bill would also make it illegal to create more embryos in one cycle than the number to be transferred.
The antiabortion-rights group Georgia Right To Life helped to draft the bill. The group seeks regulation that would treat embryos as human beings, the Journal reports. Daniel Becker, president of GRTL, said, "To us it's a human rights issue," adding that embryos should be legally protected as "living human beings and not as property." State Sen. Ralph Hudgens (R), one of the sponsors of the bill, said, "Nadya Suleman is going to cost the state of California millions of dollars over the years; the taxpayers are going to have to fund the 14 children she has," adding, "I don't want that to happen in Georgia."
According to the Journal, several IVF experts and scientists oppose the proposal, arguing that more than two or three embryos need to be implanted in some cases to achieve a pregnancy. The bill's limits would prevent women from freezing unused embryos for future procedures, they say. Sean Tipton, director of public affairs for the American Society for Reproductive Medicine -- a scientific organization that issues medical guidelines and standards for the infertility industry -- said supporters of the bill "don't understand the complicated medicine behind it." The society's guidelines urge doctors to limit the number of embryos implanted to two in women younger than age 35 and to no more than five for women older than age 40. The guidelines are not mandatory and can vary according to the condition of a woman's embryos and her individual diagnosis. Barbara Collura, executive director of Resolve -- a national infertility association based in McLean, Va. -- said, "It's the right of the person who has gone through this procedure to decide what they can do with those embryos, not their doctor, and certainly not the government" (McKay, Wall Street Journal, 3/3).
Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.
© 2009 The Advisory Board Company. All rights reserved.
The antiabortion-rights group Georgia Right To Life helped to draft the bill. The group seeks regulation that would treat embryos as human beings, the Journal reports. Daniel Becker, president of GRTL, said, "To us it's a human rights issue," adding that embryos should be legally protected as "living human beings and not as property." State Sen. Ralph Hudgens (R), one of the sponsors of the bill, said, "Nadya Suleman is going to cost the state of California millions of dollars over the years; the taxpayers are going to have to fund the 14 children she has," adding, "I don't want that to happen in Georgia."
According to the Journal, several IVF experts and scientists oppose the proposal, arguing that more than two or three embryos need to be implanted in some cases to achieve a pregnancy. The bill's limits would prevent women from freezing unused embryos for future procedures, they say. Sean Tipton, director of public affairs for the American Society for Reproductive Medicine -- a scientific organization that issues medical guidelines and standards for the infertility industry -- said supporters of the bill "don't understand the complicated medicine behind it." The society's guidelines urge doctors to limit the number of embryos implanted to two in women younger than age 35 and to no more than five for women older than age 40. The guidelines are not mandatory and can vary according to the condition of a woman's embryos and her individual diagnosis. Barbara Collura, executive director of Resolve -- a national infertility association based in McLean, Va. -- said, "It's the right of the person who has gone through this procedure to decide what they can do with those embryos, not their doctor, and certainly not the government" (McKay, Wall Street Journal, 3/3).
Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.
© 2009 The Advisory Board Company. All rights reserved.
четверг, 1 декабря 2011 г.
New Studies Indicate Age Is Important In Hormone Therapy Use
Five years ago this summer the National Institutes of Health's stopped early a major portion of the Women's Health Initiative (WHI), a large and ambitious study to address the most common causes of death, disability and impaired quality of life in postmenopausal women.
One part of the WHI sought to determine whether hormone therapy has a positive or negative impact on cardiovascular disease, cancer, and osteoporosis. The estrogen plus progestin hormone therapy trial for women with their uteruses intact was stopped in July 2002 after investigators found that the associated health risks of the combination hormone therapy outweighed the benefits.
Less than two years later, in March 2004, NIH announced that it had stopped another portion of the WHI, the estrogen-alone hormone therapy study for women who have had a hysterectomy, in the interest of safety after careful consideration of preliminary data and an average follow-up of nearly seven years.
The abrupt end of the studies and the news stories that followed left many patients confused or scared. Questions still remained about the safety and efficacy of hormone therapy, about who could take it, and for what purpose and what duration.
More information was needed about the risks and benefits of estrogen-alone hormone therapy, long-term risks for short-term use of hormone therapy, the appropriate timing of hormone therapy use in relation to a woman's onset of menopause, and the effects for women who take hormone therapy well after menopause has ended.
The medical community has learned more about hormone therapy since the WHI trials were stopped. A study published in the July 11 issue of the British Medical Journal confirmed that hormone replacement therapy should not be prescribed for the purpose of preventing chronic conditions such as heart disease in older women who are well past menopause. That same study, however, concluded that hormone therapy may be a safe, short-term option for younger women in early menopause to relieve symptoms and improve quality of life.
"If the woman is healthy and has no risk factors, low dose hormone replacement therapy use for a short period of time should confer a small risk to her health," says Helen Roberts, M.D., M.P.H., a senior lecturer of women's health issues at the University of Aukland in New Zealand. Roberts, who wrote an accompanying editorial to the British Medical Journal study, also said women with risk factors such as a previous heart attack, stroke, blood clots, breast cancer or high risk of cardiovascular disease should not use hormone therapy.
Although confusion about hormone therapy persists, this study solidifies some thinking on the issue. Short-term use of hormones in healthy women going through early menopause may not pose serious health risks. Long-term use of hormone therapy to prevent chronic diseases in older women, who begin the therapy many years after menopause, may actually increase their risk of blood clots and heart disease, and should be discouraged.
A limitation of the WHI is that it primarily studied women who began taking hormone therapy long after they had passed menopause. Researchers are still trying to determine the effects of taking hormone therapy for long periods of time if the treatment begins in the early stages of menopause. Some data suggests the health risks are lower for these women, but more studies are needed.
"There has been mounting evidence that a woman's age and amount of time since onset of menopause influence her health outcomes on estrogen, particularly her risk of heart disease," said JoAnn Manson, M.D., Dr.P.H., chief of preventative medicine at Brigham and Women's Hospital in Boston, professor of medicine at Harvard Medical School, and one of the principle investigators of the WHI. "We've recently reported in April of 2007 that when you combine the findings from the estrogen plus progesterone trial and the estrogen alone trial, there is a suggestion of a lower risk of heart disease in the women who were less than ten years since onset of menopause."
By contrast, Manson's analysis shows an increased risk of heart disease for women who were more than 20 years past menopause.
Manson's research team reported in the June 21 issue of the New England Journal of Medicine that women who were in their 50s in the estrogen alone trial tended to have less coronary artery calcium, if they received estrogen compared to placebo.
"Coronary artery calcium is a marker for plaque build-up in the arteries, hardening of the arteries and it's a strong predictor of future risk of cardiovascular, of coronary heart disease," Manson said. "So these results lend support to the theory that estrogen may slow early stages of atherosclerosis."
As research continues, taking hormone replacement therapy is an individual decision for women that depends on many factors. Women should speak with their health care providers about the potential benefits and risks that may be relevant to them as individuals.
Society for Women's Health Research (SWHR)
1025 Connecticut Ave. NW, Ste. 701
Washington, DC 20036
United States
womenshealthresearch
One part of the WHI sought to determine whether hormone therapy has a positive or negative impact on cardiovascular disease, cancer, and osteoporosis. The estrogen plus progestin hormone therapy trial for women with their uteruses intact was stopped in July 2002 after investigators found that the associated health risks of the combination hormone therapy outweighed the benefits.
Less than two years later, in March 2004, NIH announced that it had stopped another portion of the WHI, the estrogen-alone hormone therapy study for women who have had a hysterectomy, in the interest of safety after careful consideration of preliminary data and an average follow-up of nearly seven years.
The abrupt end of the studies and the news stories that followed left many patients confused or scared. Questions still remained about the safety and efficacy of hormone therapy, about who could take it, and for what purpose and what duration.
More information was needed about the risks and benefits of estrogen-alone hormone therapy, long-term risks for short-term use of hormone therapy, the appropriate timing of hormone therapy use in relation to a woman's onset of menopause, and the effects for women who take hormone therapy well after menopause has ended.
The medical community has learned more about hormone therapy since the WHI trials were stopped. A study published in the July 11 issue of the British Medical Journal confirmed that hormone replacement therapy should not be prescribed for the purpose of preventing chronic conditions such as heart disease in older women who are well past menopause. That same study, however, concluded that hormone therapy may be a safe, short-term option for younger women in early menopause to relieve symptoms and improve quality of life.
"If the woman is healthy and has no risk factors, low dose hormone replacement therapy use for a short period of time should confer a small risk to her health," says Helen Roberts, M.D., M.P.H., a senior lecturer of women's health issues at the University of Aukland in New Zealand. Roberts, who wrote an accompanying editorial to the British Medical Journal study, also said women with risk factors such as a previous heart attack, stroke, blood clots, breast cancer or high risk of cardiovascular disease should not use hormone therapy.
Although confusion about hormone therapy persists, this study solidifies some thinking on the issue. Short-term use of hormones in healthy women going through early menopause may not pose serious health risks. Long-term use of hormone therapy to prevent chronic diseases in older women, who begin the therapy many years after menopause, may actually increase their risk of blood clots and heart disease, and should be discouraged.
A limitation of the WHI is that it primarily studied women who began taking hormone therapy long after they had passed menopause. Researchers are still trying to determine the effects of taking hormone therapy for long periods of time if the treatment begins in the early stages of menopause. Some data suggests the health risks are lower for these women, but more studies are needed.
"There has been mounting evidence that a woman's age and amount of time since onset of menopause influence her health outcomes on estrogen, particularly her risk of heart disease," said JoAnn Manson, M.D., Dr.P.H., chief of preventative medicine at Brigham and Women's Hospital in Boston, professor of medicine at Harvard Medical School, and one of the principle investigators of the WHI. "We've recently reported in April of 2007 that when you combine the findings from the estrogen plus progesterone trial and the estrogen alone trial, there is a suggestion of a lower risk of heart disease in the women who were less than ten years since onset of menopause."
By contrast, Manson's analysis shows an increased risk of heart disease for women who were more than 20 years past menopause.
Manson's research team reported in the June 21 issue of the New England Journal of Medicine that women who were in their 50s in the estrogen alone trial tended to have less coronary artery calcium, if they received estrogen compared to placebo.
"Coronary artery calcium is a marker for plaque build-up in the arteries, hardening of the arteries and it's a strong predictor of future risk of cardiovascular, of coronary heart disease," Manson said. "So these results lend support to the theory that estrogen may slow early stages of atherosclerosis."
As research continues, taking hormone replacement therapy is an individual decision for women that depends on many factors. Women should speak with their health care providers about the potential benefits and risks that may be relevant to them as individuals.
Society for Women's Health Research (SWHR)
1025 Connecticut Ave. NW, Ste. 701
Washington, DC 20036
United States
womenshealthresearch
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