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FDA Review Periods are Lengthening for Biomarker-Based IVD Tests, Announces Amplion Research

FDA review periods are lengthening for IVD tests that utilize molecular biomarkers, and at a faster rate than for IVDs overall, one of the key findings in a new report published this month by Amplion Research.

“Approval and Market Trends for Biomarker-Based IVD Tests (2003-2012),” is a new research report that draws on detailed analyses of every IVD test cleared or approved by the FDA over the last decade. The report can be found at http://www.amplion.com.

While the last decade has seen a boom in the discovery of new molecular biomarkers, the progression of those molecules into new diagnostic tests has been slow. Many factors impact this rate, and one key factor is the FDA review period for tests that enter the market as packaged tests.

“Our analysis uncovered significant variability in review periods, but the overall lengthening trend is clear,” said Adam Carroll, Ph.D., Science Director at Amplion Research. “Among the variables that influence review period length, the one with the biggest impact is the selection of the FDA committee conducting the review.” Review periods by committee are broken down in the report, as are other factors that could influence review periods, such as the number of targets in a test, and the number of predicate devices cited for a 510(k) test.

Along with the detailed review period analyses, the new report also includes an analysis of the markets for biomarker-based IVDs, including the overall market size, detailed breakdowns of the companies participating, and all mergers and acquisitions among companies that developed biomarker-based IVD tests over the last decade. Geographic breakdowns are also included for all key market data.

Also included in the report is an analysis of the kinds of molecules that are being utilized in new IVD tests, with a special emphasis on the release rates and paths to market for novel molecular targets.

“The report serves users in a variety of roles,” said John Audette, Business Director at Amplion Research. “Executives and directors in regulatory, product development, and marketing roles at diagnostics and therapeutics companies will clearly get significant value from this report. But so will professionals involved in technology transfer fields, as well as equity analysts that cover companies in the diagnostics industry.”

The heads of NIH and FDA jointly described new diagnostic tests as the keys to advancing personalized medicine. Because this report analyzes release rates for the most advanced new diagnostic tests, it provides direct measurement of progress in implementing personalized medicine. Analysts and policy makers interested in personalized medicine’s progress will get essential insights from this report.

Source: Business Wire

Luminex Corporation Receives U.S. FDA Clearance for MAGPIX® Instrument with Novel xTAG® Gastrointestinal Pathogen Panel

Luminex Corporation (NASDAQ: LMNX) recently announced it has received U.S. FDA clearance of its MAGPIX instrument, with its xTAG Gastrointestinal Pathogen Panel (xTAG GPP). This is the first clinical assay to be cleared on MAGPIX. xTAG GPP is the first U.S. IVD cleared test that can simultaneously detect 11 common viral, bacterial, and parasitic causes of infectious gastroenteritis from a single patient sample.

Cardiac IVD Company Critical Diagnostics Expands Its Global Presence

Critical Diagnostics, a U.S.-based biomarker company focused on cardiovascular diseases, and makers of the Presage® ST2 Assay, recently announced several new European distribution deals.
The Company has chosen as exclusive distributors (in alphabetical order), Assut Europe in Italy and San Marino, Biochemmack in Russia, Cruinn Diagnostics in Ireland, IVD Bulgaria in Bulgaria, Life Biomedical in the UK, Maritim Ltd. In Slovenia, Croatia and Serbia, Nordic Diagnostica in Sweden, and Sopachem in Benelux.

“In addition to established distributor relationships in France, Germany and Spain, Portugal and Turkey, these new partnerships continue to broaden our presence across Europe,” notes Richard Hughes, Vice President, Business Development Europe for Critical Diagnostics. “With our extensive network of distributor partners all across the Asia Pacific region, we are truly a global company, prepared to meet the needs of the 23 million heart failure patients that suffer from this serious disease.”

Source: Critical Diagnostics

NuView Life Sciences and Thomas Jefferson University Sign Agreement for Exclusive Development and Commercialization Rights to Novel Prostate Cancer Diagnostic

NuView Life Sciences (NLS), a privately-held company developing next generation imaging and in vitro diagnostic biomarkers with the ability to identify and locate disease at the earliest stages of development, today announced it has entered into an agreement with Thomas Jefferson University for exclusive development and commercialization rights to a novel urine screen for the early detection of Prostate and Bladder Cancer.

“We are excited to add this technology into the NuView Portfolio. This in vitro diagnostic is an excellent complement to our diagnostic imaging biomarkers in development,” stated Brian Dowd, Ph.D., Vice President of Clinical and Scientific Affairs at NLS. “Early and accurate detection of Prostate and Bladder Cancer should result in a significant reduction of invasive biopsy procedures and increase the probability for successful treatment outcomes in patients.”

This novel in vitro diagnostic (IVD) detects minute quantities of cancer cells shed into the urinary tract by measuring the expression of the vasoactive intestinal peptide/pituitary adenylate cyclase activating polypeptide receptor-1 (VPAC1) receptor. To date, the technology has displayed impressive sensitivity and specificity for the identification of Prostate and Bladder Cancer in human urine samples.

Previous work by Mathew Thakur, Ph.D., academic collaborator, Professor Radiology and Director of Radiopharmaceutical Research and Molecular Imaging at Thomas Jefferson University (TJU), Philadelphia, has shown Prostate Cancer cells express the oncogene product VPAC1 in high density on their cell surface. This occurs at a very early stage in oncogenic transformation, well before cell morphology alterations for histologic confirmation, and even well before the elevation of Prostate Specific Antigen (PSA). NuView is also developing NLS-VPAC1, a positron emission tomography (PET)-based imaging agent that measures VPAC1 expression levels for identification and localization of malignant Breast and Prostate tumors.

There remains a large unmet medical need for the accurate and early detection of Prostate and Bladder Cancer. Prostate cancer is the second leading cause of cancer death in American men and over 72,000 men and women are estimated to be diagnosed with Bladder Cancer in the U.S. in 2013. Mortality from Prostate and Bladder Cancer strongly correlates with the stage of disease upon diagnosis. Therefore, the ability to detect early-stage cancer before clinical presentation would have a dramatic effect upon patient outcomes.

Currently, routine screening of the general public for bladder cancer is not recommended by any major professional organization. This is due to lack of a sensitive and specific test that will detect bladder cancer in individual not presenting clinical symptoms of disease. Current screening for Prostate Cancer by digital rectal examination (DRE) and Prostate Specific Antigen (PSA) tests results in low cancer predictive ability and increases the number of referrals for invasive biopsy.

Source: PR Newswire

Nuclea Biotechnologies, Inc. and Wilex Inc. Announce Partnership

Biomarker pioneer Nuclea Biotechnologies, Inc. recently announced a new long-term partnership with Wilex Inc. (ISIN DE0006614720/ WL6 / FSE) which could lead to more effective treatment management for women with metastatic breast cancer. The pairing of the Pittsfield and Worcesterbased biotech firm with one of Cambridge’s leading oncological biotech firms will greatly advance research and development of biomarkers, a vital component in the growing field of personalized medicine.

Nuclea discovers and develops biomarkers (genes and proteins) and diagnostic assays that can help predict which courses of treatments will be effective for certain patients, depending on their genetic makeup. Nuclea has the capability and expertise to perform in vitro diagnostic (IVD) assays in the area of oncology in a certified laboratory (CLIA) and also has access through its business relationships with hospitals and research institutions to patients in need of such tests.

In April, the clinical testing will begin in Nuclea’s newly designed, state of the art laboratory in Pittsfield, and will result in the addition of three new employees. The partnership between Nuclea and Wilex will allow oncologists greater access, through Nuclea’s laboratory, to the ELISA test to measure the HER-2/neu level in the serum portion of blood. HER-2, Human Epidermal Growth Factor Receptor 2, is a gene in the body that produces proteins which assist in the growth of cells. The serum HER-2/neu level is valuable to doctors for monitoring response to therapy and progression of disease.

“Nuclea is excited about the new partnership,” said Patrick J. Muraca, President & CEO of Nuclea. “Both companies seek to develop new biomarkers with the goal of making 21st century cancer treatments more personal and effective. With our combined experience in the production and commercialization of biomarkers, it seemed very natural for us to work together as pioneers in the field of breast cancer.”

Professor Olaf G. Wilhelm, CEO of Wilex Inc. and Wilex AG, commented: “Since Nuclea understands and focuses on gene and protein expression profiles in tumors, the serum HER-2 test is an important addition to their profiling efforts. Besides using our HER-2 ELISA in its CLIA lab Nuclea will also start R&D and validation of this test in early breast cancer and possibly other indications.”

Source: Nuclea Biotechnologies