New analysis from Frost & Sullivan has found that technology advances combined with the decreasing cost of automated systems is fuelling the growth of molecular diagnostics. According to the report, European Molecular Diagnostics Market, which focuses on the oncology, genetic diseases, infectious diseases and pharmacogenomics segments, the size of the market is estimated to reach $1.5 billion by 2015.
However, translating research into proven clinical outcomes will be a significant challenge to the sector the report notes. Proving clinical validity is also often a requirement for reimbursement of a particular test. However, obtaining such clinical proof is an expensive, lengthy and complex process.
Frost & Sullivan Industry Analyst Dominika Grzywinska says that partnerships between test developers and companies specialized in marketing of such tests will be a way to address this. Already, the market is witnessing the emergence of several small market participants, often focused on one segment or even delivering one or a couple of products. These companies are often spin-offs from research institutes or universities. As they often lack the capital for further growth, there is the strong likelihood that they will partner with other companies to successfully market their products.
Enrollment in HIV trial completed
The enrollment in a 3,000-patient clinical trial to support of a Pre-Marketing Approval application to the FDA for Chembio Diagnostics’ (OTCQB: CEMI) DPP® HIV 1/2 Assay has been completed. The assay is a rapid point-of-care test for the detection of antibodies to HIV 1 and 2 in oral fluid, finger-stick whole blood, venous whole blood, serum or plasma samples that provides a simple “reactive/non-reactive” result. The test, the company reports, is intended to be used in the preliminary diagnosis of patients with HIV in point-of-care settings such as public health and other clinics, hospital emergency rooms and physician offices. The DPP® HIV 1/2 Assay delivers visual results within approximately 15 minutes.
Diagnostic Core Facility Partnering Program launched
RayBiotech, Inc. reports that it has launched a partnering program for select diagnostic core facilities at academic and government research institutes in the United States and Canada. Under the terms of the program, the facilities will be able to provide proteomic analysis services, such as biomarker and proteomic analysis, as a component of their current services offerings at no cost to the core facilities. The ultimate goal of this program, the company says will be to aid researchers in accelerating drug discovery, drug target validation and disease-related efforts with an emphasis on impacting cancer and other disease-specific research initiatives.
Skin cholesterol testing programs for Canadians
Winnipeg-based Miraculins Inc. reports that its PreVu® skin cholesterol Point of Care test will be distributed to the Canadian retail pharmacy market by Pear Healthcare Solutions Inc., a provider of in-pharmacy health screening and education services.
Test for Fragile X Syndrome launched
JS Genetics says that it has launched a buccal swab test for the detection of Fragile X syndrome. The PCR based test, designated XCAT-FX, can identify Fragile X in both males and female patients with results typically available within three business days.