Tech Review

MDx is flourishing – and changing

13.04.2011

Molecular diagnostics (MDx), a branch of in vitro diagnostics, is based on the determination of nucleic acid sequences, mainly for medical applications. This sequence determination is largely performed using methods based on hybridization of labeled DNA probes with target nucleic acid sequences. The current MDx product scene is dominated by assays for infectious agents, cancer, and genetic diseases.

Molecular diagnostics (MDx), a branch of in vitro diagnostics, is based on the determination of nucleic acid sequences, mainly for medical applications. This sequence determination is largely performed using methods based on hybridization of labeled DNA probes with target nucleic acid sequences. The current MDx product scene is dominated by assays for infectious agents, cancer, and genetic diseases.

The MDx market is undergoing significant change, and as test automation expands, new technologies promise to yield product line extensions, as well as machines for the point-of-care market. Next-generation sequencing is awaiting further refinement before quite possibly having a major impact on the character of the MDx market.
That market is currently growing at 15% annually, nearly double the rate of the overall in vitro diagnostics market, and predictions estimate it will reach US$8.4bn by 2014. Oncology and critical care infectious disease testing sectors are likely growth leaders. Looking ahead two years, even if regulatory reform stalls, the industry still needs improved reimbursement for esoteric and expensive diagnostic products for personalized medicine.
The MDx market remains dynamic in the sense that small companies are continually developing useful new assays in newer, less mature MDx sectors. Furthermore, if and when significant regulatory reform does adversely affect MDx, it is likely to do so in a phased manner, starting with the highest risk assays and including significant levels of “grandfathering.”
In order to meet the demands for an exchange of ideas, to identify and resolve existing challenges, and to address the innovation and growth in this exciting field, the Cambridge Healthtech Institute (CHI) is holding its Second Annual Molecular Diag-

nostics Summit Europe during Biotechnica, taking place from the 11th-13th October (2011) at the Exhibition Fairgrounds in

Hannover, Germany. This year, the conference programs include:

A Molecular Diagnostics for Cancer

(October 11th-12th) & Molecular Diagnostics for Infectious Disease (October 12th-13th)
– Evaluating and adapting new technologies for the clinical setting: microarrays, sequencing, mass spec, qPCR, CTC, and immunodiagnostics
– Unique considerations for molecular diag­nostic development
– Cancer screening and diagnostics
– Infectious disease identification
– Screening for genetic diseases
– Committing resources to sample integrity and standardization for real results
– The changing landscape of regulation and reimbursement

A Convergence of Technologies for Point-of-Care Diagnostics (October 12th-13th)
a Point-of-care diagnostic development and design for:
– HIV viral load testing
– Respiratory disease
– Multiplex detection of emerging

pathogens
– MRSA detection and monitoring
– Emergency room medicine
– Stroke and cardiac applications
a Implementation, support and chal­lenges of POC testing in the:
– Hospital setting
– Home
– Physician’s office
a Discussion focus on concerns involvin­g:
– Reimbursement
– Regulatory issues
– Standardization and utility
a Specialized focus on:
– Microfluidics
– Lab-on-a-Chip
– Miniaturization
– Detection methods

A NGS: Molecular Diagnostics Magnified (October 11th-12th)
Diagnostic developments and topics to be covered for deep re-sequencing, as well as for cancer and microbial sequencing, include but are not limited to:
– Sequencing platform comparisons
– Sample preparation and management
– Targeted enrichment strategies
– Managing and analyzing the data
– Strategies for improved biomarker

identification
– Overcoming barriers to clinical adoption
– Case studies from clinical laboratories
– Future developments

More Information at
www.MolecularDiagnosticsEU.com
phone: +1-(0)781-972-5400


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