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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

Cancer Research UK and CRT Collaborate with Abcodia to Discover and Develop Tests for Early Diagnosis of Cancer

Cancer Research UK and its commercial arm, Cancer Research Technology (CRT), have joined forces with Abcodia, the biomarker validation company with a focus on cancer screening, to develop new blood tests to detect a range of cancers when they are still at a very early stage.

The strategic alliance will focus on biomarkers to detect cancers before patients develop symptoms, concentrating on cancers which currently have limited screening tests available, such as non-small cell lung cancer.

Detecting cancer earlier will give doctors the best chance to treat cancer effectively, before the disease develops and spreads when it becomes more difficult to treat. Identifying patients at an early stage will also provide the scientific and pharmaceutical communities with the ability to select patients for the development of a new generation of anti-cancer medicines.

The partnership combines Cancer Research UK’s extensive clinical oncology and scientific network with Abcodia’s expertise in the longitudinal profiling of biomarkers, as well as its exclusive access to one of the world’s largest prospective collections of serum samples available for biomarker research. This collection is derived from the UK Collaborative trial for Ovarian Cancer Screening* (UKCTOCS) run at University College London (UCL) and contains more than five million serum samples. The trial is part funded by Cancer Research UK.

The samples in the collection have been taken from healthy people annually and in many cases, up to 10 years prior to a cancer diagnosis. The collaboration will use these samples to select biomarkers which provide a clear indication of change in the early pre-diagnosis stages of disease.

Cancer Research UK, CRT and Abcodia will seek partnerships in the UK and internationally, with academic and commercial organisations which have leading-edge biomarker technology, to discover, validate and further develop the markers.

Dr Julie Barnes, Abcodia’s CEO, said: “We are delighted to be able to work with Cancer Research UK and CRT in this new global venture. The early diagnosis of cancer has never been more important and with the collective expertise that this alliance can bring, we hope to make a real difference in the field of early cancer detection and screening.”

The alliance is particularly interested in seeking markers that may be expressed in serum; for example, proteins, microRNAs – regulators of gene expression, exosomes ¬– cell-derived vesicles, autoantibodies – antibodies targeting an individual’s own proteins, and DNA methylation – a molecular switch to turn DNA on and off. Both genetic and acquired risk factors will also be investigated.

Abcodia and CRT will jointly commercialise any biomarkers discovered during the collaboration and share revenues resulting from potential licensing deals with additional third parties.

Dr Harpal Kumar, Cancer Research UK’s chief executive, said: “Earlier detection of cancer remains a huge challenge but also a tremendous opportunity. We know that for most types of cancer, the earlier we detect them, the greater the chance of being able to treat them effectively and successfully. Furthermore, treating earlier stage disease is usually associated with fewer side effects from treatment for our patients. The scope and scale of this alliance, aimed at developing new tests for a range of cancers at their earliest stage, before symptoms develop, is very exciting. The combination of expertise formed by this partnership provides a great opportunity to accelerate this vital biomarker research, which we hope will help save thousands of lives from cancer.”

Professor Ian Jacobs, Vice President at the University of Manchester, Principle Investigator of UKCTOCS and an Abcodia founder, said: “I’m delighted that the biobank developed through UKCTOCS will be used for such an important collaborative venture which has potential to yield important discoveries and to benefit patients through early detection across a range of cancers.”

Dr Keith Blundy, Cancer Research Technology’s chief executive, said: “This important alliance combines Cancer Research UK’s clinical expertise, with the commercialisation expertise of both Abcodia and CRT. Together with additional technology partners, we hope to be able to identify early detection biomarkers that will enable patients to be treated as soon as possible, ultimately saving lives.”

Source: Abcodia

Biomarker Identification May Lead to New Noninvasive Test for Colorectal Cancer Detection

The average 5-year survival for colorectal cancer (CRC) is less than 10% if metastasis occurs, but can reach 90% if detected early. A new non-invasive test has been developed that measures methylation of the SDC2 gene in tissues and blood sera. This test detected 87% of all stages of colorectal cancer cases (sensitivity) without significant difference between early and advanced stages, while correctly identifying 95% of disease-free patients (specificity). The results are published in the July issue of The Journal of Molecular Diagnostics.

According to the US Centers for Disease Control and Prevention, CRC is the second leading cancer killer in the US affecting both men and women. In 2009, close to 137,000 people in the US were diagnosed with CRC, with close to a 40% mortality rate.

There are other screening choices for CRC, including fecal occult blood testing (FOBT), fecal immunochemical testing, and colonoscopy. Colonoscopy is the gold standard of CRC screening, but patient resistance – mostly due to the unpleasant preparation – has curbed widespread adoption. FOBT is non-invasive but has limited sensitivity, particularly for early disease. A sensitive and specific non-invasive test using blood or stool could to be a more preferable option with the potential of saving many lives.

In their search for a biomarker that could be used for the early detection of CRC, investigators from Genomictree, Inc. and Yonsei University College of Medicine in Seoul, South Korea, performed DNA microarray analysis coupled with enriched methylated DNA using tissues from primary tumors and non-tumor tissues from 12 CRC patients. After step-wise filtering, they found a set of genes that were highly methylated across all of the CRC tumors. Ultimately they identified one gene, SDC2, which encodes the membrane syndecan-2 protein, a protein that is known to participate in cell proliferation, cell migration, and is expressed in colon mesenchymal cells. The methylation level of target region of SDC2 assessed in tumor tissue was found to be significantly higher than that from paired adjacent non-tumor tissue.

The next step was to clinically validate the biomarker by analyzing SDC2 methylation levels in primary tumors and paired-adjacent non-tumor tissue samples from 133 CRC patients. Investigators found that in the transcriptional regulatory region of the SDC2 gene, tumor samples showed significantly higher levels of methylation than the control samples. SDC2 methylation positivity ranged from 92.9% to 100% when samples were stratified according to stages of cancer.

Further, investigators found that the SDC2 biomarker could be measured in serum samples from CRC patients and healthy individuals. “The SDC2 methylation test was able to detect 92% for detection of stage I cancer patients indicating that SDC2 is suitable for early detection of CRC where therapeutic interventions have the greatest likelihood of curing the patient from the disease,” says first author TaeJeong Oh, PhD.

The authors suggest that the SDC2 methylation test they describe could possibly be used as an alternative to or in conjunction with colonoscopy. It could also be used to monitor cancer progression and treatment. Dr. Sungwhan An, corresponding author and CEO of Genomictree, Inc., commented: “We are very excited with this result using a small amount of serum DNA from less than 1ml of blood. I believe a greater volume of blood will further improve the clinical performance of this test. We are currently preparing another set of clinical validation studies evaluating SDC2 methylation in serum DNA from patients with early adenoma.” In future research the authors will explore whether this biomarker is specific to CRC or universal among other cancers.

Source: Gnome-Wide Identification and Validation of a Novel Methylation Biomarker, SDC2, for Blood-Based Detection of Colorectal Cancer

Source: EurekAlert!

Matrix-Bio Options Metabolite Biomarker Technology from Purdue University to Evaluate Opportunities for New Cancer Diagnostic Tests

Matrix-Bio Inc., a diagnostics company that uses metabolite profiling to detect cancer and other diseases, has signed an exclusive agreement with the Purdue Research Foundation optioning metabolite biomarker technology and eight patent applications to evaluate the commercial potential of cancer diagnostics tests based on the technologies.

The optioned technologies include metabolite biomarkers for detecting esophageal, liver, pancreatic and colon cancer; for identifying liver cancer in patients with hepatitis C; and for predicting preoperative chemotherapy effectiveness for breast cancer treatment. Matrix-Bio’s agreement is for one year with an option to extend the agreement. No other terms of the agreement were released.

The new agreement builds on the existing master license agreement between Matrix-Bio and Purdue Research Foundation for breast cancer biomarkers and metabolite profiling technology developed by Dan Raftery, Matrix-Bio chief scientific officer and founder, while he was a member of the Purdue University research faculty. Raftery is now director of the Northwest Metabolomics Research Center at the University of Washington in Seattle, and is also a member of the Fred Hutchinson Cancer Research Center in Seattle, one of the world’s leading cancer research centers.

Matrix-Bio CEO Eric Beier said the agreement will enable the company to significantly expand its pipeline of cancer detection and monitoring tests, further advancing the company’s leadership in metabolomics-based cancer diagnostic technologies.

“Metabolite profiling is an emerging field of diagnostics that looks at the changes in small molecule biomarkers in cells. Patterns of these metabolite biomarkers in the blood are altered when cancer is present,” Beier said. “Dr. Raftery’s technology identifies metabolic changes with very high sensitivity and specificity, and can detect various cancers in early, more treatable stages more accurately than currently available tests. Studies have also demonstrated that metabolite profiling can assist in monitoring cancer treatment.”

The announcement comes on the heels of an exclusive global licensing and marketing agreement for metabolomic biomarkers Matrix-Bio signed with Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services. Under the agreement, Quest Diagnostics has the rights to use the Matrix-Bio biomarkers for the future, potential development of a clinical lab-developed test to aid in the detection of breast cancer recurrence. Quest Diagnostics also has the option to pursue an appropriate regulatory pathway for an in vitro diagnostic version of the test. Additional terms were not disclosed.

Source: Business Wire

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