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Vermillion’s OVA1 Receives New Statement by Society of Gynecologic Oncology

Vermillion, Inc.’s (NASDAQ: VRML), a multivariate diagnostics company focused on gynecologic cancers and women’s health, OVA1® has received a new statement on clinical validation and medical use issued by the Society of Gynecologic Oncology (SGO).

Citing peer-reviewed publications from two pivotal clinical studies of OVA1® versus standard of care, the statement also referred to OVA1 use within the context of the American Congress of Obstetricians and Gynecologists’ (ACOG) 2011 Committee Opinion, “The Role of the Obstetrician-Gynecologist in the Early Detection of Epithelial Ovarian Cancer.” This guideline, updated from a previous version issued in 2002, covers the management of adnexal masses, including serum markers for ovarian cancer detection.

SGO stated: “…The test may be useful in identifying women who should be referred to a gynecologic oncologist. Recent data have suggested that the OVA1 test along with physician clinical assessment may improve detection rates of malignancies among women with pelvic masses planning surgery.” The complete statement on OVA1 clinical validation and medical use is available on SGO’s website here.
This second SGO statement on OVA1 since its FDA clearance in 2009 represents another significant step toward acceptance of OVA1 as the standard of care for pre-surgically evaluating the risk of ovarian cancer in women with adnexal masses.

The new statement does two things:

  • Refers to publications of OVA1’s two pivotal clinical studies, comprised of the original FDA validation study published in June 2011 and the OVA500 “intended use” study published in 2013. Together, this offers an extensive, peer-reviewed proof source for physicians and payers to assess OVA1’s clinical performance and comparative medical benefits versus today’s standard of care.
  • Places OVA1 use in the context of current ACOG practice guidelines, where CA125 has been used off-label for many years to predict malignancy before surgery, although with inferior performance.

Two key developments in 2013 underlined the timeliness of this updated statement by SGO. The first was the publication of the company’s second pivotal clinical study, OVA500, in the February edition of Gynecologic Oncology. OVA500 was led by Dr. Robert E. Bristow, director of Gynecologic Oncology Services at UC Irvine Healthcare in Orange, California. The second development was a study in the June edition of the journal Obstetrics and Gynecology, which made the front page of the New York Times under the headline, “Widespread Flaws Found in Ovarian Cancer Treatment.” This study, also led by Dr. Bristow, reported that most women with ovarian cancer “are treated by doctors and hospitals that see few cases of the disease and lack expertise in the complex surgery and chemotherapy that can prolong life.” Dr. Bristow said, “If we could just make sure that women get to the people who are trained to take care of them, the impact would be much greater than that of any new chemotherapy drug or biological agent.”

After reviewing the SGO statement, Dr. Hector Chapa, MD, FACOG and medical director of the Women’s Specialty Center in Dallas observed: “This new statement by SGO affirms the important role which OVA1 should play in the workup of patients with an adnexal mass, and particularly before surgery is undertaken by a surgeon uncertified in the gynecologic oncology specialty. This is important because a large number of malignancies are discovered after a surgery where the mass was thought to be benign after negative CA125 or physical examination. Now, we await an updated guideline from ACOG, replacing CA125 with the greatly improved sensitivity and negative predictive value of OVA1. After all, ACOG first mentioned excitement about OVA1 in the Gynecology Practice bulletin of March 2011, prior to publication of the two clinical studies cited by SGO. I believe the new SGO statement is a very positive advance for patients, physicians and health insurance companies alike.”

Vermillion President and CEO Thomas McLain commented: “We highly value the support SGO has provided in two statements about the benefits of OVA1 testing. For patients with ovarian cancer, Vermillion understands that timely access to a trained gynecologic oncology specialist is critical. Optimal treatment, survival and post-surgical outcomes all depend upon improvements in the detection of ovarian malignancies of all types, and as early as possible. OVA1 directly addresses the difficult challenge of identifying the more than 22,000 ovarian malignancies that are associated with 300,000 gynecologic surgeries performed every year. We look forward to supporting ACOG’s review of this new clinical data and the SGO statement. We are committed to working to improve the standard of care for all gynecologic surgery patients at risk of ovarian cancer.”

Source: PR Newswire

UAB Study to Examine Sense of Smell as Risk Factor for Parkinson’s

A reduced sense of smell, or hyposmia, might be a risk factor for developing Parkinson’s disease, and the University of Alabama at Birmingham (UAB) is participating in a study of hyposmia and two other potential risk factors. The study, sponsored by The Michael J. Fox Foundation for Parkinson’s Research, is a new arm of the long-running Parkinson’s Progression Markers Initiative (PPMI), which looks to attract as many as 20,000 people worldwide to participate in a brief online survey about the sense of smell.

The study is looking for people older than 60 who do not have Parkinson’s disease to take the online survey. Most respondents will then be mailed a scratch and sniff smell test and a brief questionnaire, to be completed at home. Some individuals may also be asked to undergo more extensive testing.

The study will also enroll individuals who have rapid eye movement sleep behavior disorder (RBD) or a mutation in the LRRK2 gene, which is the single greatest known genetic contributor to Parkinson’s disease.

“Understanding risk factors for Parkinson’s disease could help to identify therapies that may prevent the onset of motor symptoms in future generations of PD patients,” said David Standaert, M.D., Ph.D., professor and chair of the Department of Neurology at UAB. “UAB is proud to participate in this innovative research and respectfully ask our local community for volunteers for the study.”

UAB has been part of the PPMI study since it was launched in 2010. The now $55 million landmark observational clinical study was established to look for one biomarker of PD or more, and now it seeks to better understand potential risk factors of the disease. UAB is one of 23 participating sites worldwide and is among the top five sites in numbers of participants.

“In the third year of PPMI, it is evident that a large-scale biomarker study is not only possible in Parkinson’s disease, but is already yielding scientific insights that could help transform the field of Parkinson’s research,” said Todd Sherer, CEO of the Michael J. Fox Foundation. “None of this progress would be possible without the willing volunteers who donate their time and energy to the pursuit of a cure.”

Source: University of Alabama at Birmingham

The Michael J. Fox Foundation Launches New Arm Of Parkinson’s Progression Markers Initiative Studying At-Risk Populations In Parkinson’s Disease

The Parkinson’s Progression Markers Initiative (PPMI), a landmark biomarker clinical study, has completed enrollment of its initial 600-member cohort of Parkinson’s patients and controls, and will launch additional study cohorts to leverage the existing PPMI infrastructure and evaluate multiple potential biomarkers for Parkinson’s disease (PD). The first of these new cohorts launches today and will investigate risk factors for PD that may enable diagnosis before the onset of motor symptoms.

The pre-motor arm of PPMI will enroll participants who do not have Parkinson’s disease but do have one of three potential risk factors for PD: a reduced sense of smell (hyposmia); rapid eye movement sleep behavior disorder (RBD); or a mutation in the LRRK2 gene (the single greatest genetic contributor to PD known to date). Research to date indicates that each of these factors can be linked to an increased risk of developing Parkinson’s disease, though many people with these conditions do not go on to develop PD. Validating these risk factors and better characterizing their connection to Parkinson’s could enable detection of the disease prior to the onset of motor symptoms and open new avenues toward identifying biomarkers — critical tools in the quest for therapies that can slow or stop disease progression.

“If scientists can learn more about the biological processes taking place in people with any of these three risk factors, we may be able to define biomarkers even before typical symptoms begin,” said Ken Marek , MD, principal investigator of PPMI and president and senior scientist at the Institute for Neurodegenerative Disorders in New Haven, Connecticut. “Finding a biomarker for PD could mean earlier diagnosis of the disease and lead to new drugs that may delay or even prevent the onset of motor symptoms.”

PPMI seeks 10,000 individuals to complete a brief online survey to determine eligibility for the loss-of-smell cohort. Participants in the other groups will largely be enrolled via research centers. This new arm will take place at 23 sites across the world where participants will undergo the same clinical assessments, imaging and collection of biospecimens as the original study.

PPMI’s open-source design and infrastructure has opened the door to evaluating multiple potential biomarkers under one umbrella, building on a precedent created by the Alzheimer’s Disease Neuroimaging Initiative (ADNI). All PPMI clinical data and characterized biosamples are available in real time, providing researchers around the world with an unprecedented resource to help speed and unify disparate biomarker validation studies. To date, 460 scientists from academia and industry have downloaded PPMI data more than 50,000 times in over 30 countries worldwide, and 21 applications have been made for use of PPMI biospecimens in biomarker research. Initial baseline data from PPMI’s original newly diagnosed and control cohorts will be presented this June at the Movement Disorders Society and is expected to be published later this year.

“Lessons learned from Alzheimer’s have taught us the importance of pursuing biomarker research concurrent with therapeutic development,” said Todd Sherer , Ph.D., CEO of The Michael J. Fox Foundation for Parkinson’s Research. “In the third year of PPMI, it is evident that a large-scale biomarker study is not only possible in Parkinson’s disease, but is already yielding scientific insights that could help transform the field’s pursuit of a cure.”

Source: PR Newswire

Exosome Diagnostics Presents Data Demonstrating Utility of Urine Exosome Technology to Predict Prostate Biopsy Outcome at American Urological Association Annual Meeting

Exosome Diagnostics, a leading developer of biofluid-based molecular diagnostic products for use in personalized medicine research and clinical diagnostics, recently presented data at the American Urological Association Annual Meeting in San Diego demonstrating the performance of urine exosome technology in accurately predicting the outcome of a prostate biopsy.

In the study, a urine sample was collected from patients scheduled to undergo prostate biopsy or radical prostatectomy. Exosomes containing ribonucleic acids (RNA) shed into the urine from the prostate were analyzed using Exosome Diagnostics’s proprietary EXO70 Urine RNA Isolation Kit in conjunction with real-time PCR. Notably, patients did not undergo a digital rectal exam or a prostate massage prior to the urine collection.

“There is clearly an unmet need in the field of prostate cancer detection and prognosis today,” said James McKiernan, M.D., professor of urology and the director of urologic oncology at NewYork-Presbyterian Hospital/Columbia University Medical Center in New York City. “A noninvasive method to improve upon PSA and its potential to predict who does or does not have cancer would immediately benefit patients and help address the controversy surrounding prostate cancer detection. A potential future application—the ability to use exosome technology to determine who has significant prostate cancer prior to performing a biopsy—would be revolutionary. In these preliminary studies exosome technology has shown promise to deliver on both of these challenges.”

James McCullough, chief executive officer of Exosome added, “These results are part of a multi-center clinical study program for EXO106, the first in vitro diagnostic in our exosome genitourinary (GU) oncology program. EXO106 is being developed to provide patients and clinicians with a non-invasive diagnostic that can deliver real-time information following the finding of an elevated PSA. We have now completed testing on over 1,000 urine samples from patient to characterize diagnostic performance.”

In the study, biopsy patients were divided into two cohorts. The first cohort was tested using a known prostate cancer biomarker, while a novel four-gene prostate cancer signature was tested in the second cohort. Both groups were stratified based on whether their biopsies were positive or negative. Besides predicting positive biopsy outcome, exosome testing was able to distinguish histologically less aggressive, lower Gleason scores (≤7) cancers from those with higher, more aggressive Gleason scores (≥8). The results demonstrate that urinary exosome-derived RNA can be used to non-invasively evaluate gene expression in the prostate and accurately predict the likelihood of a positive or negative needle biopsy in addition to distinguishing more aggressive cancers.

The study was funded by the Prostate Cancer Foundation.

Source: PR Newswire

The Michael J. Fox Foundation Launches New Arm of Parkinson’s Progression Markers Initiative Studying At-Risk Populations in Parkinson’s Disease

The Parkinson’s Progression Markers Initiative (PPMI), a landmark biomarker clinical study, has completed enrollment of its initial 600-member cohort of Parkinson’s patients and controls, and will launch additional study cohorts to leverage the existing PPMI infrastructure and evaluate multiple potential biomarkers for Parkinson’s disease (PD). The first of these new cohorts launches today and will investigate risk factors for PD that may enable diagnosis before the onset of motor symptoms.

The pre-motor arm of PPMI will enroll participants who do not have Parkinson’s disease but do have one of three potential risk factors for PD: a reduced sense of smell (hyposmia); rapid eye movement sleep behavior disorder (RBD); or a mutation in the LRRK2 gene (the single greatest genetic contributor to PD known to date). Research to date indicates that each of these factors can be linked to an increased risk of developing Parkinson’s disease, though many people with these conditions do not go on to develop PD. Validating these risk factors and better characterizing their connection to Parkinson’s could enable detection of the disease prior to the onset of motor symptoms and open new avenues toward identifying biomarkers — critical tools in the quest for therapies that can slow or stop disease progression.

“If scientists can learn more about the biological processes taking place in people with any of these three risk factors, we may be able to define biomarkers even before typical symptoms begin,” said Ken Marek, MD, principal investigator of PPMI and president and senior scientist at the Institute for Neurodegenerative Disorders in New Haven, Connecticut. “Finding a biomarker for PD could mean earlier diagnosis of the disease and lead to new drugs that may delay or even prevent the onset of motor symptoms.”

PPMI seeks 10,000 individuals to complete a brief online survey to determine eligibility for the loss-of-smell cohort. Participants in the other groups will largely be enrolled via research centers. This new arm will take place at 23 sites across the world where participants will undergo the same clinical assessments, imaging and collection of biospecimens as the original study.

PPMI’s open-source design and infrastructure has opened the door to evaluating multiple potential biomarkers under one umbrella, building on a precedent created by the Alzheimer’s Disease Neuroimaging Initiative (ADNI). All PPMI clinical data and characterized biosamples are available in real time, providing researchers around the world with an unprecedented resource to help speed and unify disparate biomarker validation studies. To date, 460 scientists from academia and industry have downloaded PPMI data more than 50,000 times in over 30 countries worldwide, and 21 applications have been made for use of PPMI biospecimens in biomarker research. Initial baseline data from PPMI’s original newly diagnosed and control cohorts will be presented this June at the Movement Disorders Society and is expected to be published later this year.

“Lessons learned from Alzheimer’s have taught us the importance of pursuing biomarker research concurrent with therapeutic development,” said Todd Sherer, PhD, CEO of The Michael J. Fox Foundation for Parkinson’s Research. “In the third year of PPMI, it is evident that a large-scale biomarker study is not only possible in Parkinson’s disease, but is already yielding scientific insights that could help transform the field’s pursuit of a cure.”

Source: Michael J. Fox Foundation