Kalorama: Top Five Trends to Watch in IVD in 2016

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Jan 05, 2016, 03:09 ET

NEW YORK, Jan. 5, 2016 /PRNewswire/ -- Emerging infectious disease threats, progress on sequencing in clinical medicine, near patient DNA testing are among the trends that manufacturers and investors should be on the lookout for in vitro diagnostic (IVD) testing in 2016. The market research publisher specializes in vitro diagnostic testing markets. Recently the healthcare research marketer released the sixth edition of its report in Molecular Diagnostics, which covers many of these trends in detail.

Expect More Acquisitions by Heavyweights: IVD testing is complex now and companies will need to acquire the technology parts they lack to continue to compete. Last year there were scores of acquisitions, partnership deals and distribution agreements in IVD. In March, Roche announced a global distribution agreement for kits and enzymes for cellular analysis, proteomics and conventional PCR applications with Sigma-Aldrich. In April 2015, Roche became the majority shareholder in Foundation Medicine. Foundation Medicine is a molecular information company dedicated to understanding the genomic changes that contribute to each patient's unique cancer. March 2015, Qiagen announced an expansion of its portfolio of liquid biopsies through the acquisition of AdnaGen's (Hamburg, Germany) technology from Alere Inc. AdnaGen markets the CE Marked line of AdnaTests that enable enrichment and molecular analysis of CTCs from blood samples including AdnaTest BreastCancer and AdnaTest Prostate Cancer, which are already marketed in Europe and offer improved treatment monitoring and earlier detection of tumor relapse.

Pragmatic Personalized Medicine: Kalorama Information's global report on molecular diagnostics lists over 50 PGx (companion) test products on the market or in development. In the area of infectious diseases, personalized medicine (PGx) tests detect therapy resistance factors in HIV, hepatitis, hospital acquired infections and tuberculosis. Tests for hereditary diseases such as cystic fibrosis, multiple sclerosis, Alzheimer's disease, cardiac diseases and others are helping hone into new therapeutic approaches. Molecular assays in coagulation help treat difficult to manage patients and dose drugs such as Coumadin and Plavix. The contribution that personalized medicine has made in oncology is almost beyond measure. The anticipated death sentence associated with cancer has been all but eliminated in some cancers such as breast, colon and prostate. Technologies such as next-generation sequencing-based gene panels are making the heralded concepts of targeted medicine a reality. 2016 should see more solutions, and we expect, companies will limit expectation about immediate delivery of exact personalized care and focus on obtainable results. As more gene variants are linked to various forms of cancer and more drugs are targeted to those specific forms of disease, lab professionals claim that the regulatory path for commercial tests does not respond to physicians' need because it takes too long to adjust test panels. In house developed lab panels can be updated as soon as validated gene targets are discovered.

Some government efforts from 2015 should bear fruit. In January 2015, President Barack Obama outlined the Precision Medicine Initiative that is seeking $215 million from the U.S. Congress to build a research cohort of 1 million participants, and advance data sharing, regulatory, and privacy standards to advance more molecularly informed personalized treatments. On the private payer scene, March 2015, Blue Cross Blue Shield (BCBS) of Michigan and the University of Michigan Health System announced they are collaborating with physicians and laboratories across the state to improve molecular testing practices.

The Service Industry Is Here to Stay: The test service model has become a major route for highly sophisticated and specialized molecular tests. At one time, the most successful molecular test services offered cancer diagnostics using in situ hybridization (ISH), sequencing and PCR analysis of biopsied tissue. More recently test services have emerged for prenatal chromosome mutation analysis, autism, psychosocial drug metabolism, gastro intestinal autoimmune diseases and cardiac risk genetics, among others. The service model for molecular tests has been adopted by private reference labs, large hospitals and company-owned test services. The company-owned test service business model is primarily a phenomenon of the U.S. There is a long history for the commercialization of highly specific assays as test services. Many groundbreaking tests in the areas of viral load testing, anatomical pathology special analyses and molecular assays were first launched by reference labs in the U.S. This sensitized the medical community to the value of these test services. The first generation of these tests targeted small markets where the financial investment for FDA market clearance – especially the PMA route that would have been required for these unique and first to market tests – would have been difficult to recuperate with a commercial test kit.

Emerging Disease Threats - A number of emerging diseases are making their global presence a public health problem. Once thought to be limited geographically to the tropics or developing countries, they continue to show up all over the world and are among the most complex and dangerous infectious diseases to prevent and control. The Ebola threat has awakened the American public to pandemic disease threats and created an opportunity for elevated approvals on related test devices. But Ebola is by no means the only emerging disease threat, nor is it the most likely to find cases in the United States. The rise of global transportation, trade and climate change allows insects to easily carry disease organisms across borders, infecting animals as well as humans because of increased global travel there is the fear that disease usually found only in the developing world can be transported, unwittingly, to countries of the developed world as well. Furthermore, developed nations are no longer safe from diseases such as malaria. Chagas and Dengue Fever, once thought to be a developing world problem alone. Today, infectious diseases can travel in a matter of hours to any part of the globe. A number of natural and human actions influence the introduction and spread of these diseases.

Near Patient Molecular: To test for infectious diseases where time is of great concern, Kalorama believes 2016 will see more developments in POC molecular diagnostics. In 2015, Alere announced It's Alere™ i Influenza A & B, that provides molecular flu results in less than 15 minutes . Cepheid announced its 9 inches tall GeneXpert® Omni, the world's most portable molecular diagnostics system enabling unprecedented access to accurate and fast diagnosis for patients suspected of TB, HIV and Ebola. Such products also push infectious disease testing into the point-of-care (POC) and near-patient testing arena, allowing providers to initiate care during the same visit or day. These announcements build on previous developments in near-patient molecular last year.

Kalorama published three reports recently that covered these topics in detail. The World Market for Molecular Diagnostics, 6th Edition, The World Market for Cancer Diagnostics, 6th Edition, and The World Market for Infectious Disease Diagnostic Tests. For information on these reports visit: http://www.kaloramainformation.com/.

About Kalorama Information

Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama's website and are also available on www.marketresearch.com and www.profound.com.

We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog at www.kaloramainformation.com.

Contact:
Bruce Carlson
(212) 807-2622
[email protected]
www.KaloramaInformation.com

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SOURCE Kalorama Information