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The Molecular Edge

MDx Automation

Vol. 20 • Issue 9 • Page 14

Molecular Diagnostics

Despite the economic effects in 2009 carrying over into 2010, the U.S. Diagnostic Nucleic Acid Testing (NAT) market continues to be an area of investment by manufacturers for the development of automated instruments and new tests, especially for infectious disease and oncology applications. With automation for NAT lagging behind the more mature immunoassay and chemistry clinical testing segments due to the complex sample preparation required for NAT, there's still a great need for easy-to-use systems to help laboratories, especially smaller hospitals, bring NAT in-house. The response by manufacturers can be seen at various NAT-focused conferences with new technologies and a variety of platforms, including modular, fully integrated (sample in, result out) and even potential point-of-care systems being promoted.

In late 2010, Boston Biomedical Consultants Inc. conducted an independent survey (not intended for statistical use) of 60 hospital laboratories throughout the U.S. to better understand current and future needs for automation of laboratories performing NAT; 47% of completed surveys were from members of AMP, the leading organization dedicated to this discipline.

Survey Demographics

Approximately 50% of individuals surveyed performed NAT in molecular pathology laboratories (followed by ~20% in microbiology laboratories), with roughly 50% of laboratories in medium-sized institutions (450-750 beds), and an equal split of the remaining laboratories in small- and large-sized hospitals. More than half of the individuals had >10 years of experience performing NAT/overseeing NAT laboratory operations, and the median NAT test volume per year among this group was 15,000.

Nearly all respondents indicated stable to increasing test volume, with approximately one-third indicating >+10% test volume increases over the past two years. Approximately half of respondents performed ≤10 NAT assays in-house with the most respondents (14) indicating 11-15 NAT assays performed onsite.

Of the assays performed, the most prevalent FDA-approved tests offered in descending order were CT/GC, HIV-VL, HCV-VL and HPV testing. By test volume, CT/GC testing led, followed by HPV; test volume growth was fastest for lower-volume assays such CMV-VL and BK virus as well as other cancer markers followed by CT/GC and HPV testing.

Just over 90% of respondents indicated that physicians have a moderate to very high impact on decisions to bring in a new test or technology; although physicians drive the need for certain tests, the decision on which platform to use is the purview of laboratory management.

Current Platforms

Respondents were asked which instruments were present in their laboratoriess for various tests. By aggregated response, Roche led in manufacturer presence, followed by Cepheid; the remaining manufacturers include Luminex, QIAGEN, Gen-Probe, Abbott, BD and Siemens. Roche's instruments were most often the choice for HBV, HCV and HIV viral load testing while Cepheid's platforms had the greatest use for C. difficile and MRSA testing. For LDTs, Roche's LightCycler® instrument was the most prevalent (29 responses) followed by Cepheid's Smart Cycler® (14 responses). Cepheid, second to market with an integrated platform (after Gen-Probe's TIGRIS® DTS®) and first to gain a "moderate complexity" regulatory status for a PCR-based test, offers customers scalability with its GeneXpert® platform; it has been able to build its approved test menu over the years to grow its customer base.

Future Growth

Over the next two years, nine laboratories indicated they were anticipating validating Gen-Probe's PANTHER instrument, slated for launch in the U.S. in late 2011/early 2012. Approximately two-thirds of respondents indicated they were looking to increase the number of tests offered (C. difficile led) and the level of automation in their laboratories over the next two years. For instrument selection, the most important factor was assay performance characteristics followed by price and automation.

Respondents were asked to rank a list of overall system features on a scale from "not important at all" to "always important;" after sales support/technical support and reliability (long mean time before failure) were ranked as "always important" in deciding to bring in automation. When asked what was the most important feature in bringing in automation, the ability to conduct different assays simultaneously, reliability, and onboard test menu/platform consolidation were identified (in descending order).

There was an equal split for integrated and modular automated instruments. Respondents cited less hands-on time, ease-of-use, space and time savings, and less risk of error/contamination as reasons supporting integrated systems; reduced flexibility of testing was noted as a disadvantage. Modular systems were thought to have greater flexibility for test menu development, ability to use a preparation system for many tests within a laboratory, and improved turnaround times.

Of the respondents surveyed, 24 noted there was no impact from the economic conditions over the past 18-24 months on decisions to bring in automated instruments; however, this was closely followed by 19 respondents indicating they have been unable to bring in automation because of capital budget freezes or cuts, with eight respondents each indicating they did not have the funds necessary to conduct instrument and/or test evaluations and were delayed in bringing in automation as a result of uncertain reimbursement. Eight labs surveyed brought in automation to help offset head count reductions.

Kerri Weinert and Carrie Cresenzi are with Boston Biomedical Consultants Inc. (BBC).


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