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Genalyte and Barbara Davis Diabetes Center Collaborate to Advance Multiplexed Antigen Panel for Early Diagnosis of Type 1 Diabetes

Genalyte, Inc. recently announced the launch of its Type 1 Diabetes (T1D) antigen panel that runs on the Maverick Detection System. The Genalyte T1D antigen panel is the first multiplexed assay that measures seven autoantibodies associated with the destruction of pancreatic islet cells seen in type 1 diabetes. In a related development, Genalyte reported that it is collaborating with the Barbara Davis Center for Childhood Diabetes (BDC) at the University of Colorado School of Medicine to further develop and test multiplexed antigen panels for the early detection of T1D.

The Genalyte T1D antigen panel was developed as part of the first phase of a Small Business Innovation Research (SBIR) grant awarded to Genalyte to develop multiplexed assays for the early detection and monitoring of type 1 diabetes. The $500,000 grant from the National Institute of Diabetes and Digestive and Kidney Diseases also provides support for expansion of the approach to allow autoantibody response profiling by multiple criteria, which is expected to enhance the ability of researchers and clinicians to detect and monitor the development of the disease.

Martin Gleeson, PhD, Chief Scientific Officer of Genalyte, noted, “The pioneering work of Drs. George Eisenbarth and Liping Yu at BDC established assays for the measurement of islet autoantibodies. These rogue elements of the immune system eventually destroy the pancreatic islet cells that produce insulin. The unique capabilities of our Maverick detection platform have the potential to provide researchers and clinicians with tools to detect and track this process from an early stage, when interventions to interrupt the disease process may be feasible.”

An estimated three million individuals in the U.S. have T1D, an autoimmune disorder that leads to life-long dependence on insulin injections. New disease-modifying therapies may have the potential to reduce or stop the destruction of islet cells in patients at risk of developing T1D. The availability of tools to identify these patients early in the disease process would facilitate the development and use of these preventative therapies.

“We are pleased to offer our innovative T1D antigen panel to diabetes researchers worldwide at the same time that we are working with Dr. Liping Yu and his lab at the Barbara Davis Diabetes Center to expand the utility of the approach,” added Dr. Gleeson. “BDC is a long-time leader in the quest to develop curative therapies for type 1 diabetes, and we are delighted to collaborate with them to develop the tools that may help make this dream a reality.”

The Genalyte T1D antigen panel requires only a 2 to 5 μL serum or plasma sample and provides results in less than 15 minutes, without the use of dyes, fluorescent probes or radioactive labels. The T1D panel measures autoantibodies to insulin, proinsulin, GAD 65, GAD 67, IA-2 (PTPRN, ICA512), phogrin (PTPRN2, IA-2ß) and ZnT8 (SLC30A8). For more information, visit http://genalyte.com/maverick-type-1-diabetes-t1d-assay-kit/.

Other commercially available tests for the Maverick Detection System include MT-ADA, ENA 4, ENA 6 and ANA 14 assay kits. Additionally, Genalyte offers researchers a Custom Spotting Service that loads proteins supplied by customers, such as antibodies, peptides, biomarkers, cytokines and antigens, on to standard-format Genalyte chips that are ready to be run on the Maverick System.

Maverick assays are currently available for research use only.

Source: Genalyte

PerkinElmer Expands Prenatal Screening Test Offerings, Introducing First Early Onset Preeclampsia Screening Test in the U.S.

PerkinElmer, a global leader in human and environmental health and an innovator in the field of prenatal screening for more than thirty years, announced today the first available early onset preeclampsia screening test in the United States. The PreeclampsiaScreen™ | T1 serum screening test enables physicians to more precisely detect asymptomatic patients in the first trimester of pregnancy who are at high risk for developing the dangerous condition, allowing for earlier identification, management and intervention. Early onset preeclampsia is a potentially serious condition that affects 0.5% of all pregnancies, often contributing more to the pregnant mother’s and baby’s risks of morbidity and mortality than does the late form of the disorder.

“This first of its kind screen is our latest commitment to providing clinicians with new, innovative ways to address some of today’s most challenging prenatal clinical scenarios,” said Jim Corbett, Senior Vice President and President, Diagnostics and Life Sciences & Technology for PerkinElmer. “Together with our recent advances, including offering a non-invasive prenatal test based on cell-free fetal DNA, plus a wide range of prenatal testing from biochemical screening to SNP microarray testing to detect birth defects and chromosome abnormalities, we’re giving physicians effective new tools for patient management.”

According to Dr. Jiri Sonek, MD RDMS, President, Fetal Medicine Foundation USA, and Adjunct Professor, Department of Obstetrics and Gynecology from Wright State University, “Preeclampsia is one of the remaining great challenges in obstetrics. It is a major cause of maternal, fetal, and neonatal morbidity and mortality. Fortunately, some physicians may recommend a simple and inexpensive intervention to reduce the risk of preeclampsia which is available in the form of low-dose aspirin. However, this treatment is effective only if begun early in pregnancy. That is why first trimester screening is such a critical component of preeclampsia prevention.”

Early onset preeclampsia is defined as preeclampsia, a sudden increase in blood pressure and protein in the urine, which leads to delivery of the fetus prior to 34 weeks’ gestation. If found early, options such as increased monitoring, modified activity, bed rest and medication can help reduce or avoid complications related to early onset preeclampsia.

PreeclampsiaScreen™ | T1 is administered during the first trimester of pregnancy through a simple blood test to detect three biochemical markers in the mother’s blood: PAPP-A (pregnancy-associated plasma protein-A); PlGF (placental growth factor) and AFP (alpha fetoprotein) that, when evaluated collectively with personal demographic data, provide an individual risk of developing early onset preeclampsia. Physicians have the option to provide two additional biophysical measurements for their patients — mean arterial pressure (MAP) and uterine artery Doppler pulsatility index (UtAD-PI) – each increasing the sensitivity of the screen when included in the testing protocol.

Source: PerkinElmer

Abcodia and Cellmid Collaborate on the Studying of Midkine for Early Diagnosis of Colorectal Cancer

Abcodia Ltd, the UK biomarker validation company with a focus on early detection of cancer, today announced that it has entered into a collaboration agreement with Cellmid Ltd (ASX: CDY), for the testing of midkine (MK) in a collection of longitudinal serum samples using Cellmid’s MK-ELISA.

The initial objective of the collaboration is to validate midkine as a useful marker for the screening and early diagnosis of colorectal cancer. Serum samples will be provided by Abcodia and testing will be carried out by Cellmid.

The collaboration focuses on the assessment of midkine in pre-diagnosis serum samples. Abcodia has exclusive access to a unique biobank of 5,000,000 serum samples collected through the UK Collaborative Trial for Ovarian Cancer Screening.

The biobank was derived from 200,000 initially healthy volunteers. Since first recruitment, more than 27,000 individuals have been diagnosed with cancer. A subset of 50,000 individuals within the 200,000 cohort have provided samples annually, making this a unique longitudinal resource for testing midkine levels early, even before symptoms appear.

The collaboration agreement allows for the testing of multiple cancer indications, but initially targeting the early detection and screening of colorectal cancer. Colorectal cancer ranks third in incidence and second in cancer-related mortality in the United States.

Although the five year survival rate for stage 1 cancers is as high as 74%, for stage 4 cancers, when the cancer has metastasized, this reduces to just 6%. Early diagnosis of colorectal cancer, before the spread to the lymph nodes and distant sites, is vital to reduce death rates.

Midkine has been extensively validated as a biomarker in a range of other cancers. t has been shown to appear very early in some solid tumours with demonstrated utility in disease management and monitoring. Since 2012 midkine has been commercially used as one of the biomarkers in CxBladder®, a diagnostic test for the monitoring of bladder cancer patients.

Cellmid’s CEO, Maria Halasz, said: “We are excited to collaborate with the expert team at Abcodia to measure midkine levels in their extensive collection of pre-diagnosis serum samples. It is an exceptional opportunity for Cellmid to take part in the development of an important cancer diagnostic test.”

Abcodia’s CEO, Dr Julie Barnes, said: “I am delighted to be able to form this partnership with Cellmid. Midkine is an intriguing marker and I hope that we can reveal an interesting profile in the early pre-symptomatic phase of colorectal cancer. The uptake of current screening methods for colorectal cancer (colonoscopy and haemoccult testing) is low and a simple blood test could help significantly improve early diagnosis and therefore improve treatment outcomes.”

Source: Abcodia

New Blood Test Detects Colon Cancer Before it Develops

A new blood test developed in the Gastrointestinal Cancer Research Lab at Baylor Research Institute is showing very promising results for finding cancer-related microRNA in the blood before a tumor develops in the colon.

The test results, published in the latest issue of the Journal of the National Cancer Institute, are exciting and promising because this simple blood-based test examines the levels of a single microRNA – a small RNA molecule that can be readily identified in a wide variety of bodily fluids, including blood. In this seminal study the investigators studied several hundred patients with colorectal polyps and cancers and reported that measuring levels of miR-21 in the blood can accurately identify up to 92 percent of patients with colorectal cancer. Even more importantly, not only is this test good for non-invasively identifying patients who already have colorectal cancer, but it can accurately identify up to 82 percent of patients with advanced colonic polyps, which present the highest risk for developing into colorectal cancers several years later in life.

“The development of this biomarker is highly encouraging because high mortality rates associated with colorectal cancer is a consequence of late detection of this disease, underscoring the need for improved early detection, prevention, risk assessment and intervention,” said Ajay Goel, PhD, director of Epigenetics and Cancer Prevention at Baylor Research Institute. Early detection of advanced colorectal polyps and cancers is considered the most relevant target for screening strategies and the best approach to improving survival of these patients. “This blood-based test could be transformative in how we screen patients for colorectal cancer; it would save lives and could result in major savings of health care dollars,” said Michael Ramsay, MD, president of Baylor Research Institute.

While more testing needs to be done, the findings were enough to warrant an editorial in the highly regarded Journal by Heinz-Josef Lenz, MD, associate director for clinical research at the University of Southern California‟s Norris Comprehensive Cancer Center. “MiR-21 may not be ‘just another brick in the wall’ but rather may be the keystone leading to a molecularly justified, miRNA-based biomarker era in colorectal cancer,” Dr. Lenz said in the Journal.

Study: Serum miR-21 as a Diagnostic and Prognostic Biomarker in Colorectal Cancer

Source: PR Newswire

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