Kalorama at AACC 2016

This year, the clinical lab industry - and the IVD industry that serves it - will be in Philadelphia August 1-4th for an enormous meeting with thousands of participants.  Kalorama Information will be there.  Our IVD analysts Shara Rosen and Emil Salazar, Editor Bill Imbornoni, Publisher Bruce Carlson and several of our sales representatives from parent company MarketResearch.com will be in attendance at the Clinical Lab Expo and at press conferences and sessions.    

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With Final Rule, PAMA Set to Spark Changes in Lab Market and IVD Strategy

This blog post reviews regulatory developments in the United States relevant to the clinical lab services and U.S. in vitro diagnostics (IVD) markets. For more information regarding recent market developments or trends in either market, Kalorama Information offers the market research reports United States Market for In Vitro Diagnostic Tests and Clinical Laboratory Services Market.

In late June of this year, the Centers for Medicare and Medicaid Services (CMS) announced the final rule of the 2014 Protecting Access to Medicare Act (PAMA) or a sweeping market-based pricing reform for Medicare-reimbursed lab tests. PAMA is intended to introduce a more organic methodology to reimbursement adjustments for lab testing under Medicare and will replace uniform cuts implemented across the Clinical Laboratory Fee Schedule (CLFS) along with the Affordable Care Act (ACA). The recent CMS final rule delays implementation of market-based pricing and expands the body of applicable labs in order to make prices more reflective of the entire lab market. The law has the potential to significantly cut Medicare reimbursement prices on routinely performed, highly automated tests – sparking further consolidation in the clinical lab services market – and increase IVD industry emphasis upon the development of new biomarkers and sophisticated and esoteric assays.

Nearly 4 Billion-Dollar Market for IVD Packaging

In vitro diagnostic tests require specialized boxes, bottles, bags and plates to protects crucial chemicals and insure a quality result each time a test is performed. Thus it's not surprising that growth in IVD drives growth in packaging. That’s the conclusion of The Freedonia Group’s new study, In Vitro Diagnostic Test Packaging. Take two trends for example. The increasing use of point-of-care tests and the development of high-quality molecular testing supplies.

Direct-to-Consumer Services Put Down Roots in U.S. Lab Testing Market

Still framed as an open proposition in healthcare, the direct-to-consumer (DTC) lab testing market has already captured robust demand from U.S. consumers. Sales of DTC testing services have rapidly grown outside the traditional paradigm of physician-facilitated clinical testing. Kalorama Information’s Direct-to-Consumer Laboratory Testing Market has served as an important reference in recent articles by the New York Times, Forbes, and Becker’s Hospital Review. Whereas media coverage has focused largely on the medical implications of lab results communicated without physician guidance, market growth has proceeded briskly for DTC lab services through their considerable market strengths.

Luminex Acquisition of Nanosphere Continues Trend of Investment in Decentralized Molecular Testing

This blog post reviews the recent history of acquisitions and investment in the area of decentralized molecular diagnostics. Kalorama Information’s The Market and Potential for Molecular Point of Care Diagnostics provides the current market, projected future sales and total available markets in 2020 for molecular POC diagnostics for flu, strep A, RSV, CT/NG, group B strep (GBS), HPV, HSV, vaginitis, HIV, TB, hepatitis, malaria and many other disease areas.

On May 16, Luminex Corporation announced a definitive agreement with Nanosphere, Inc. to acquire the latter for approximately $58 million. The acquisition will broaden Luminex’s addressable market in clinical molecular testing, adding platform capabilities and clients outside of the Luminex ARIES platform and xTAG panels.  The Nanosphere Verigene and Verigene Flex platforms cater to the hospital market for automated molecular testing platforms, and could lead to opportunities in other decentralized markets for molecular testing (outside of centralized clinical labs or reference labs). Luminex’s acquisition of Nanosphere continues a string of company and technology acquisitions that have shaped the early molecular POC diagnostics industry.

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