-- If undetected, vasa previa is frequently fatal for newborns --

Read St. Petersburg Times story about this fetal surgery...

Mia Demier sleeps peacefully, unaware of her potentially precarious entry into the world. "She's a great baby -- happy and smart. We couldn't picture our lives without her," her mom says.

Tampa, FL (Dec. 18, 2007) -- A University of South Florida fetal surgeon at Tampa General Hospital successfully treated in utero a rare but potentially devastating condition in which placental blood vessels block the birth canal and can rupture during labor, leaving the baby without vital blood and oxygen. If undiagnosed, the condition known as vasa previa is frequently deadly for newborns.

The case was reported by Ruben Quintero, MD, professor and director of the Division of Maternal-Fetal Medicine at USF Health, in the December 2007 issue of the Journal of Maternal-Fetal and Neonatal Medicine. Dr. Quintero used a laser to seal off the abnormally positioned fetal blood vessels connecting the two parts of a bilobed placenta. The procedure essentially removed the unprotected vessels crossing the cervical entrance to the birth canal beneath the baby, so that the vessels would not tear or break and cause rapid fetal hemorrhage.

“This is the first time laser therapy has been used to correct vasa previa,” said Dr. Quintero, a pioneer in the field of minimally-invasive fetal surgery. “Patients have described this prenatal condition as a ticking time bomb waiting to go off. A patient with vasa previa lives with the constant worry that if her water breaks at any time, she may lose the pregnancy.”

USF-TGH fetal surgeon Dr. Ruben Quintero with Mary Guinea and her daughter Mia Demier, now a healthy 9-month-old.

“Dr. Quintero has long been recognized for his excellence in innovation in fetal intervention. His successful in utero laser treatment of vasa previa is potentially a very important breakthrough because it may avert fetal hemorrhage,” said Frank Chervenak, MD, chairman of the Department of Obstetrics and Gynecology, NewYork-Presbyterian Hospital/Weill Cornell Medical Center. “This report must be followed by scientifically and ethically rigorous clinical investigation before being offered to patients as the standard of care.”

Dr. Quintero is an expert at pinpointing abnormal placental vessels with an endoscope inserted through the abdominal wall and into the uterus. Using a selective endoscopic technique he developed, he had already performed hundreds of laser ablations of malfunctioning placental blood vessels to treat twin-to-twin transfusion syndrome.

Vasa previa occurs in about 1 in every 2,000 to 5,000 pregnancies. Despite advances in medical technology, the condition often goes undetected until it is too late and then an emergency caesarian section and aggressive resuscitation is required to save the baby.

Vasa previa has a high death rate if it’s not caught before labor, because many babies lose most or all of their blood supply within a few minutes when their mother’s water breaks. A color Doppler ultrasound showing blood flow in the womb can help detect vasa previa, but unless a woman is identified as having a high-risk pregnancy, she typically does not get this more sophisticated test during pregnancy.

The 37-year-old patient described in the published report had an abnormal placenta with one smaller and one larger lobe linked by two exposed fetal vessels. Normally the blood vessels feeding the fetus are embedded in the placenta or umbilical cord, but in this case the vessels linked the two lobes. This would not necessarily be life-threatening if the unsupported vessels were positioned in other areas of the uterus – but these vessels were caught between the fetus and the opening to the birth canal (cervix).

Such exposed vessels are prone to tearing when the patient’s amniotic membranes rupture, or they may be compressed between the baby and the walls of the birth canal during birth, cutting off oxygen to the baby.

Cristobal Demier holds his daughter in the Tampa General NICU.

There is no uniform standard of care for vasa previa. When the condition is diagnosed, physicians often manage it by recommending bed rest, hospitalizing the patient beginning at 7 months of pregnancy and scheduling an elective cesarean delivery before labor. However, Dr. Quintero suggests, the risk of fetal death might be substantially minimized if the unprotected vessels were ablated in utero. Laser treatment might eliminate prolonged hospitalization and the obligatory C-section, and allow the pregnancy to progress to term with a vaginal delivery, he said.

The patient described in Dr. Quintero’s paper was counseled about management alternatives and elected to undergo laser surgery to seal the abnormal fetal vessels. The procedure was performed at Tampa General Hospital at about 23 weeks of pregnancy without complications, Dr. Quintero reported. However, the patient subsequently required a cesarean delivery at 27 weeks for ruptured membranes, which may have been prompted by the breech position of the fetus. After a stay in the neonatal intensive care unit, the infant was discharged and is thriving today at 9 months old.

“This case is a first step requiring more study to determine the effectiveness of the procedure and its risks,” Dr. Quintero said. “But it demonstrates that, if an accurate diagnosis is made, something proactive may be done to treat vasa previa.

“It may provide physicians with justification and greater impetus to look for the prenatal diagnosis early, and hopefully save more babies.”

Joining Dr. Quintero on the case were members of the USF Health fetal therapy team -- Eftichia Kontopoulos, MD, assistant professor of obstetrics and gynecology, and Tampa General Hospital nurses Patricia Bornick and Mary Allen.

Dr. Quintero uses a selective endoscopic technique he developed to perform laser ablations of malfunctioning fetal blood vessels.

- USF Health -

USF Health is dedicated to creating a model of health care based on understanding the full spectrum of health. It includes the University of South Florida’s colleges of medicine, nursing, and public health; the schools of biomedical sciences as well as physical therapy & rehabilitation sciences; and the USF Physicians Group. With $308 million in research funding last year, USF is one of the nation’s top 63 public research universities and one of Florida’s top three research universities.

The November/December 2007 edition of the Journal of Hospice and Palliative Nursing features the article of a recent graduate of the USF College of Nursing’s Gero-psychiatry masters program, and the Adult Primary Care & Research program. The study is authored by Lynn A. McCasland, RN, MS.

The study, entitled “Providing Hospice and Palliative Care to the Seriously and Persistently Mentally Ill”, is designed to help hospice nurses care for patients diagnosed with serious and persistent mental illnesses (SPMI). These illnesses can include schizophrenia, bipolar disorder, depression and dementia. To illustrate this growing issue in nursing, McCasland's study indicates that of the more than 1 million people in hospice care nationwide in 2004, as many as 54,000 patients may have been suffering from one or more serious and persistent metal illnesses.

“It is important that hospice nurses be better prepared to care for individuals who fall into this diagnostic category. Having some understanding of medications used to treat mental illness is equally important.”
Lynn McCasland, RN, MS

The graduate student's former teachers applaud him for bringing national attention to the critical issue of hospice care for the mentally ill. "Lynn was one of my students in Adult Primary Care & Research. He was a delight. Absolutely brilliant in his field and so passionate about this issue ", said Adrienne Berarducci, PhD, ARNP, Associate Professor, USF College of Nursing.

McCasland graduated from the master's program in nursing last semester and was awarded the Clinical Excellence Award upon graduation. His advisor, Lois O. Gonzalez, PhD, ARNP, an Associate Professor in the USF College of Nursing, had this to say of the award winning student: "As a graduate student, Lynn was always abreast of the current research and evidence-based literature. His ability to apply theoretical knowledge to practice, as well as his scholarly talents, were qualities that earned him his nomination and selection for one of the College of Nursing Graduate Clinical Excellence Awards. He is compassionate, caring practitioner and we at the College of Nursing are very proud of his accomplishments. He will be an asset to the Johnny Byrd Center."

McCasland now works at the Johnnie Byrd Sr. Alzheimer's Center & Research Institute, located on the campus of USF Health.

To view full study published in the Journal of Hospice and Palliative Nursing, click here.

USF HOT DOCS encourages a practical approach to problem-solving

Cristina Ortiz and son Sebastian, 2

It was clear to Cristina Ortiz that from a very early age her son Sebastian Santa was different.

While other youngsters were chatting away, Sebastian was learning his first words. And while simple routines like going grocery shopping were almost fun adventures for most toddlers, a short visit to the store would throw the two and a half-year-old boy into complete confusion resulting in bad, attention-getting behaviors.

For Ortiz, the pressure was enormous. Not only was she faced with a child who had clear development challenges, but she also felt intense culpability.

“I was very desperate and feeling very, very guilty about my son’s behavior,” said Ortiz. “I did not understand why he was behaving the way he was.”

After franticly searching for help, Ortiz was directed to a program that would ultimately change her, and her son’s life, called HOT DOCS (Helping Our Toddlers, Developing Our Children’s Skills), a six week, hands-on course offered by USF’s Department of Pediatrics, Division of Child Development.

Ortiz, whose son benefitted from HOT DOCS, is now lead facilitator for the bilingual classes.

Using interactive, practical activities, parents and caregivers learn to problem-solve and address challenging behaviors such as constant whining, temper tantrums, aggression, and non-compliance by designing their own behavior strategy with the guidance of HOT DOCS coaches.

Ortiz is not alone. About 20 percent of all children have challenging behavior problems, said Kathleen Armstrong, PhD, director of the Pediatric Psychology Program at USF, and author of the HOT DOCS program.

The earlier the problems start, she observes, the more constant and extreme the associated negative outcomes are over time.

“The single best predictor of delinquency in adolescence is behavior problems in the preschool years,” Dr. Armstrong said. Many interventions have been developed; however, few focus on very young children and their families, as does HOT DOCS.

Initiated three years ago, HOT DOCS was an outgrowth of a federal grant to document research on young children who displayed challenging behavior patterns. Since then the program has been generously funded by the Children’s Board of Hillsborough County, which has enabled the course to reach more than 300 families.

The program’s team is made up of graduate students from psychology and public health, medical students, and a parent support specialist, all working together to help the family devise the most appropriate intervention program for each specific child.

L to R: The HOT DOCS team includes Cathy Armstrong, director of the USF Pediatric Psychology Program; Jillian Williams; Abraham A. Salinas; and Heather Curtiss.

Using an evidence-based method (Positive Behavioral Support) the entire concept is so leading edge because the parents become the main actors, and providers help only as partners, says Abraham A. Salinas, a PhD student in Community and Family Health, and a coach in the HOT DOCS bilingual Spanish class.

"This is a partnership among parents and providers which is different than the traditional power relationship of professional versus patients,” Salinas said. “Only through the eyes of parents are we going to be able to see the true potential of each child.”

It is interesting to note the wide demographics of those who have attended the course. Participants have ranged in age from 23 to 69, and represent the entire gamut of educational, ethnic, and socioeconomic backgrounds. As different as their characteristics might be, their response to the program has been overwhelmingly positive.

According to Jillian Williams, a doctoral intern in the Psychology program who is writing her thesis on the effectiveness of HOT DOCS, most of the caregivers reported that the program was beneficial to their families (97%), the trainers were knowledgeable and effective instructors (100%), the parenting tips were beneficial (96%), the special play strategies promoted positive interactions with their children (97%), the program positively impacted parenting attitudes and practices (95%), and the program positively impacted children's behavior (96%).

For Sebastian, now age 4, and his mother, the changes have been dramatic. Now the family has implemented structured rituals that not only make daily activities easier and more enjoyable, but also transferable.

Bedtime, for example, used to be a veritable nightmare with Sebastian refusing to get into his pajamas, waking several times a night and often ending up in bed with Mom and Dad before he’d fall asleep. Now, Sebastian’s routine is so precise and carefree that by repeating it wherever they are, the family can even travel and avoid behavioral issues.

Jillian Williams (standing), a psychology doctoral intern, helps facilitate a HOT DOCS session.

Ortiz became such a proponent that she is now the lead facilitator for the bilingual course.

HOT DOCS is also critical to USF, and its outreach efforts into the greater community. “It’s a chance for USF to translate research into practice,” said Dr. Armstrong. “And the program is free, making it accessible to families who could not otherwise receive this kind of support.”

HOT DOCS is available to any Hillsborough County resident, with a child under age six, who has concerns about their child’s behavior.

The six-week course meets two hours each week in the CMS building, 13101 N. Bruce B. Downs Blvd., on the USF Tampa campus. Special sessions are offered in Spanish, and for caregivers of children with autism spectrum disorders.

“Parenting is the most important job we will ever do, and none of us receive training,” Dr. Armstrong said. “HOT DOCS provides parents with the tools to solve everyday behavior problems and help prepare their children for success in school, and in life.”

The next HOT DOCS sessions begin in Tampa on Jan 15, 2008. In addition, beginning Jan. 14, USF will offer its first HOT DOCS program in the CMS Building at 4718 Old Highway 47 in Lakeland. For more information, please contact Jillian Williams, 813-974-1189, jlwillia@mail.usf.edu (English-speaking classes, all locations), or Cristina Ortiz, 813-974-0355, cortiz@health.usf.edu (Spanish-speaking classes, Tampa only).

OTHER USF HEALTH DEVELOPMENTAL PEDIATRIC PROGRAMS

Two additional USF developmental pediatrics programs include Coping Cats and Early Steps. Coping Cats teaches children ages 9 to 12 with anxiety disorders how to manage their own anxious feelings. The program accepts insurance, Medicaid and private pay, with a sliding fee if necessary. For more information, contact Heather Curtiss at hcurtiss@health.usf.edu.

Early Steps, a federally-funded program for intervention of infants and toddlers with developmental delays, provides free services such as speech therapy and support for eligible families. Contact John Landi at 813-974-6072 or Jlandi@health.usf.edu.

Other services offered include multidisciplinary team evaluations (pediatrics, psychology, neurology), consultations, and individualized intervention planning and medical management for children struggling with school, behavioral and social issues.

- Story by Sheryl Kay
- Photos by John Lofreddo/USF Health Media Center

Photo of the Charter Class of the USF Orthopaedic Surgery Residency Program started July 1, 2007. Six residents are (from L to R) Paul Edwards, MD; Eric Henderson, MD; Odion Binitie, MD; Stephen Wilson, MD; German Marulanda, MD, and Derek Weichel, MD.

The November 2007, Volume I, No. 9 Edition of AAOS Now has published a story on the return of the Orthopaedics Residency Training Program to the University of South Florida's College of Medicine. The article written by journal writer Jennie McKee is entitled "Orthopaedics Makes a Comeback at USF - University reopens orthopaedic training program after 17 years."

AAOS Now is produced by the American Academy of Orthopaedic Surgeons and the American Association of Orthopaedic Surgeons - with a membership nationwide exceeding 31,000.

Click here to view journal article.

Newsbrief by Lissette Campos, USF Health Communications
Photo by Eric Younghans, USF Health Media Center

USF Taps Cleveland Clinic Neonatologist to fill Muma Endowed Chair

Dr. Lewis Rubin will help make USF a premier center for helping premature and other at-risk infants.

Tampa, FL (Dec. 10, 2007) – Lewis P. Rubin, MD, neonatologist and a co-director for the Cleveland Clinic’s Fetal Care Center, has been recruited to fill the Pamela S. and Leslie M. Muma Endowed Chair in Neonatology at the University of South Florida. Dr. Rubin will also serve as professor and chief of neonatology in USF Health’s Department of Pediatrics and medical director of the Neonatal Intensive Care Unit at Tampa General Hospital. He starts April 1.

In addition to conducting research meant to advance the care and well-being of premature babies, Dr. Rubin will work with Ruben Quintero, MD, director of the USF Health Division of Maternal and Fetal Medicine, and regional hospitals to expand the diagnostic and treatment capacity of the USF Fetal Therapy Center.

“This donation and this recruitment means we’ll have one of the nation’s premier centers for helping infants in trouble,” said Stephen K. Klasko, MD, MBA, vice president for USF Health and dean of the College of Medicine.

“Dr. Rubin and his collaboration with existing USF Health specialists will be a tremendous resource for the region, and I believe will quickly be one of the world’s centers for neonatal treatment that helps prevent lifelong complications in these children.”

“Dr. Rubin is an internationally respected researcher in newborn medicine as well as an experienced clinician and educator,” said Robert M. Nelson, MD, professor and chair of the Department of Pediatrics at USF Health. “The strengths he brings to USF and the Tampa Bay region will help us attract other top investigators and clinicians and advance our neonatal, pediatric and obstetric services to the next level.”

The $4-million research endowed chair that Dr. Rubin will hold is a vital piece of one the largest gifts given in Florida to support research and care for newborns. The Mumas’ gift -- with a total impact of $14-million after eligible state matches -- supports an initiative by Tampa General Hospital and USF to build research and medical teams, laboratories at USF Health and expand the NICU at TGH.

“My wife and I look forward to making Tampa our home,” Dr. Rubin said. “The leadership at USF and USF Health has a very impressive vision for building on strengths and advancing the University and the Tampa Bay area as a world-class center for research, education and care that will improve the lives of women and infants.”

“A goal of the Division of Neonatology is to provide innovative, technologically sophisticated, evidence-based, and family-centered care,” Dr. Rubin said. “We want to make the NICU as welcoming a place as possible for families and maximize the comfort and health of these smallest and most vulnerable babies.”

Dr. Rubin has served as chair of the Department of Neonatology and staff scientist in the Department of Cell Biology at the Cleveland Clinic and a professor of pediatrics and molecular medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University in Cleveland, OH. He also directs neonatology for the Cleveland Clinic Fetal Care Center, teamed with physicians who direct obstetrics and surgery and a fetal care nurse coordinator.

Dr. Rubin specializes in intensive care of premature babies and infants who have complex congenital, metabolic, cardiorespiratory or neurodevelopmental disorders.

His laboratory studies the interplay between genetics and environment, focusing on the effects of intrauterine stress, nutrition and other factors on fetal and newborn growth and development. He is directing a multisite clinical study, including TGH, evaluating whether antioxidant-enriched formula can improve lung function and decrease the risk of neurodevelopmental abnormalities in low-birth-weight and other at-risk babies.

He plans to bring several members of his Cleveland research team to USF. The group will work out of USF/All Children’s Hospital Children’s Research Institute in St. Petersburg and collaborate with faculty at USF and affiliates Tampa General, All Children’s and Moffitt Cancer Center.

At the Cleveland Clinic, Dr. Rubin helped create a comprehensive fetal evaluation program that gives patients access to a broad range of maternal, pediatric and surgical subspecialists. He wants to help establish a similar program at the USF Fetal Therapy Center.

“Many of the core specialists already are present at TGH and USF Health,” he said. “We will develop a multidisciplinary program where a woman with any suspicion or diagnosis of a fetal problem can, in one day, have diagnostic tests like high resolution ultrasound, fetal echocardiography or fetal MRI and meet with a team of experienced experts. The family will come away with fuller understanding and a plan for continuing prenatal care, delivery, and options for fetal or neonatal treatment. USF Health and Tampa Bay should increasingly become known as an international destination for evaluation and care of the fetus and newborn.”

Dr. Rubin’s team plans to work with faculty in the USF Health Center for Aging and Brain Repair, who conduct cutting-edge research on potential treatments using stem cells derived from human umbilical cord blood and adult bone marrow cells. Such therapies may have applications for replacing or repairing cell populations in the damaged lungs, hearts or brains of premature infants as well as in aging adults, Dr. Rubin said.

“The best perinatal and neonatal research does not occur in isolation. It thrives by close collaboration with clinicians and scientists at the forefront in diseases that, at first glance, may not seem relevant to newborns,” Dr. Rubin said.

“For instance, a major complication for preemies is bleeding into the brain’s white matter. Neurological diseases in adults, including Alzheimer’s, multiple sclerosis and stroke involve similar processes of nerve inflammation and regeneration," he said. “Our partnering with colleagues in the USF Signature Interdisciplinary Programs should advance prevention and treatments for persons across the lifespan.”

Dr. Rubin also hopes to work with faculty in the USF Colleges of Nursing and Public Health, which have strong community-based research initiatives in maternal and child health.

Dr. Rubin received his MD degree from Yale School of Medicine and completed a residency in pediatrics at Children’s Hospital in Boston, MA and a joint fellowship program in neonatology at Children’s Hospital, Brigham & Women’s Hospital and Beth Israel Hospital. He also took postdoctoral fellowships in molecular endocrinology and pediatric endocrinology. Before joining the Cleveland Clinic and Lerner College of Medicine, he was a faculty member at Harvard Medical School and an associate professor of pediatrics and co-director of the Fetal Medicine Program at Brown University Medical School in Providence, RI. He is listed in Best Doctors in America, 2007-2008.

Dr. Rubin is a member of the American Pediatric Society and is on the editorial board of several scientific journals. He is the author of more than 50 peer-reviewed journal articles and a dozen book chapters and reviews. He has a strong track record of National Institutes of Health funding and is currently the principal investigator for a $1.1-million NIH grant studying how carotenoids (antioxidant micronutrients) regulate fetal vitamin A production and gene expression.

- USF Health -

USF Health is dedicated to creating a model of health care based on understanding the full spectrum of health. It includes the University of South Florida’s colleges of medicine, nursing, and public health; the schools of biomedical sciences as well as physical therapy & rehabilitation sciences; and the USF Physicians Group. With $308 million in research funding last year, USF is one of the nation’s top 63 public research universities and one of Florida’s top three research universities.

Click here to view video of this story...

In the USF Motion Analysis Lab, physical therapist Jason Highsmith, right, uses sensors and special cameras to track movements of the computerized prosthetic limb worn by Iraq War veteran Ed Salau.

TAMPA, Fla. (Nov. 30, 2007) – Forget running 60 miles-per-hour or jumping 20 feet straight up into the air. Those feats of cyborg superheroes like The Six-Million Dollar Man are not what people look for when selecting mechanical replacement limbs.

For those who’ve lost a leg above the knee, they just want to be able to get up from a chair without assistance or contortions, or to simply climb a flight of stairs, said M. Jason Highsmith, a visiting assistant professor at the University of South Florida’s School of Physical Therapy & Rehabilitative Sciences.

“Right now, we’re not at the point of superhuman abilities,” said Highsmith, who is performing tests on the Ossur Power Knee with help from College of Engineering graduate students. “We just want to restore function.”

Highsmith is studying how well the Power Knee mimics the movements of a real knee.

The Power Knee is being compared to four other prosthetic knees to see how well it helps the user stand up, sit down or walk stairs. Those activities most people take for granted can be an incredible chore that puts strain on the remaining parts of the body.

“When we stand or sit, we keep our bodyweight more or less equal,” Highsmith said, demonstrating how a person with both legs rises and sits. “But traditionally, a person with a prosthetic leg would have to shift to their sound side in order to get up or sit down.”

Favoring one side over the other can cause problems in the long run. One side will atrophy while the other becomes over-developed, increasing the risk for injury. Also, there will be increased wear-and-tear to the remaining leg, Highsmith said, potentially causing an early onset of arthritis.

The Power Knee works by means of pressure sensors hidden in the sole of the shoe on the sound leg and in an ankle bracelet on that same leg. When the amputee sits or rises, the sensors send a message to the prosthetic leg telling it to move, Highsmith said.

Ed Salau, front, walks down a flight of stairs while Randy Thran waits his turn.

One of those Power Knee users taking part in the test is Ed Salau, the east coast area director for the Wounded Warrior Project, an organization that helps veterans injured in Iraq or Afghanistan settle back into a normal life. Salau, a 37-year-old from New Bern, N.C., lost his left leg three years ago outside Tikrit, Iraq, when a rocket-propelled grenade struck his vehicle.

“This leg is unique,” Salau said. “It’s the only leg that powers me around. The other legs are great products, but they’re very passive. I have to move them.” While it’s not perfect, Salau said he’s glad to be able to take part in testing that may contribute to a new generation of prosthetics.

Highsmith said this research has other implications besides improving the prosthetic. Insurance companies have been reluctant to pay for Power Knees because they are considered “experimental.” With a price tag of $100,000 to $125,000, these new prosthetics are five to six times as much as the current mechanical legs that cost around $20,000.

“Until we can prove their efficacy, the insurance companies are not onboard,” he said.

Another test subject, Randy Thran, 45, lost his right leg as a result of injuries he incurred as a police officer in Savannah, GA. During his career, he’d endured 14 operations on his knees which suffered repeated beating on the job. But it was the last beating that cost him his leg.

“He was just a drug suspect,” Thran recalled. “I was trying to apprehend him and my legs were hitting these big chunks of asphalt. Then he gave me a good sidekick to the leg and snapped it right in half.” Thran said his doctor told him there was no way to save the leg and it would have to be amputated.

Like Salau, Thran said getting a Power Knee has helped him. “It’s got good qualities, like for getting up stairs,” Thran said. “And if you have to do a lot of longer walking, it doesn’t tire you out as much.”

USF's testing is supported by a $1-million grant from the Department of Education. Highsmith expects to publish the results of the prosthetic knee study in early 2008.

- Story by Sean Ledig/USF University Relations
- Photos by Eric Younghans/USF Health Media Center

- GeoPharma acquires patent rights for test developed by USF Health's Patricia Kruk -

Patricia Kruk, PhD

An aggressive, silent killer of women could soon be caught and identified much faster thanks to new technology developed at the University of South Florida.

The USF Division of Patents & Licensing has recently entered into a strategic partnership with Largo, FL.-based GeoPharma, Inc. to advance a critical development in the area of women’s health. GeoPharma signed an agreement last week with the USF Research Foundation to acquire worldwide patent rights of a test for early detection of ovarian cancer using a patient’s urine sample. Valerie McDevitt, director of the Division of Patents and Licensing for the USF Research Park, said she looks forward to partnering with GeoPharma.

“We’re very excited,” McDevitt said. “It’s a local company so we’re hoping for good things. We want to support local businesses. This could help large numbers of women and it is part of USF President Judy Genshaft’s mission to promote biotech at USF.”

Kotha Sekharam, president of GeoPharma, said the company “came very fast” to an agreement on licensing the test.

Sekharam said that ovarian cancer is often called a “silent killer” because of vague symptoms that are unnoticed until the disease has progressed to an advanced stage. The most deadly of all gynecological cancers, ovarian cancer is also the most curable with early detection.

“An ovarian cancer diagnostic test with (a) high reliability, (b) ease of use and (c) detection at an early stage could save thousands of women from untimely deaths. Our technology could offer significant help in this direction” he said.

With a five-year survival rate of only about 35 percent, the National Cancer Institute estimates 15,280 women in the US will die from ovarian cancer in 2007.

When ovarian cancer spreads from the pelvis, less than 30 percent of patients survive long-term. When it is limited to the ovaries, 90 percent of patients can be cured. Currently early stage diagnosis occurs in only 20 percent of the ovarian cancer cases.

Patricia Kruk, PhD, who developed the test at USF and is an affiliate at H. Lee Moffitt Cancer Center, has long wanted to find a way to catch the disease in its early stages.

“My interest has always been to identify some of the early changes to ovarian epithelial cells that cause them to become malignant,” said Kruk, associate professor of pathology and cell biology at USF Health.

Ovarian cancer “doesn’t get nearly as much press as other women’s cancers, but it is the most lethal gynecological cancer,” Kruk added. “There are almost no symptoms and there is no screening test for it. Unfortunately, if it was detected when the disease has not spread beyond the ovary, you could remove the ovary and significantly improve patient survival.”

Currently, there is no approved test for early detection of ovarian cancer. The only ovarian cancer diagnostic test is the CA-125 blood test that is approved by FDA to monitor progression of the disease. For best accuracy, CA-125 test is done with other physical tests like transvaginal sonography and pelvic examination.

Preliminary clinical studies have been conducted at USF and further studies are under progress. GeoPharma will initiate necessary steps for FDA approval.

- Story by Sean Ledig/USF University Relations
- Photo by Eric Younghans/USF Health Media Center