Laboratory Industry Report

By the end of this year, the average referral expense per reportable result of sending a test to an outside reference laboratory is expected to fall to $32.84, down 11 percent from 2007’s figure of $36.98, according to analysis of hospital labs by the laboratory consulting firm Chi Solutions Inc. (Ann Arbor, Mich.). The median is expected to drop 12 percent from $33.30 in 2007 to $29.26 in 2008 (see Figure 1). Hospital labs currently dominate the $50 billion clinical lab market with 54 percent market share.

It was a rough October for the lab industry and the G-2 Laboratory Stock Index, which was down 29 percent over the past five weeks and 30 percent so far this year. But in the last two weeks the Index has leveled out, according to up-to-the-minute tracking of the Index available on www.g2reports.com.

Over 66 percent of starting salaries for pathologists are ranging between $100,000 to $250,000, according to the American Society for Clinical Pathology’s (ASCP) 2008 Resident Council Fellowship and Job Market Survey. Of the 121 respondents in 2008, 20 percent said they would be starting at under $100,000, 33 percent indicated they were receiving a starting salary in the range of $100,000 to $150,000, and another 33 percent said their starting salaries were between $150,000 and $250,000. Fourteen percent of the pathologists indicated they would be starting at a salary greater than $250,000 (see Figure 1). These salaries do not include benefits.

Since Pathology Services, P.C.’s CEO David Glenn increased the hourly rate paid to customer service representatives in 2006 from $9 per hour to $12 per hour, he estimates he’s saved $3,000 a year. This has been realized primarily by decreasing turnover—at a monthly savings of approximately $1,000—as well as by improving efficiency, eliminating one-half of a full-time employee (FTE) at a savings of over $8,000.

While Wall Street continues to find its footing following the recent infusion of $700 billion from the federal government, the current economic downturn is likely to further fuel consolidation in the lab industry, according to several CEOs and executives from both reference and esoteric labs who were recently interviewed by LIR. However, the tight credit market is likely to complicate the merger and acquisition (M&A) process.

Los Angeles-based Response Genetics wants to sell its lung and colorectal cancer tests beyond the West Coast market and is partnering with NeoGenomics Laboratories (Ft. Myers, Fla.) to develop a national sales strategy. NeoGenomics is a CLIA-certified lab that specializes in cancer genetic testing and offers testing services that include cytogenetics, flow cytometry, molecular diagnostics, and fluorescence in-situ hybridization–also known as FISH.

Some former executives with American Esoteric Labs (AEL) and Lab One have joined forces to enter the dental molecular diagnostics market with the recent launch of Nashville-based OralDNA Labs. The initial menu will feature two saliva-based diagnostic panels—MyPerioPathsm and MyPerioIDsm—based on technology previously only available in Europe to target periodontal disease. The company plans on eventually expanding this menu to offer a broad offering of molecular, genetic, and other clinical tests.

In a recent study analyzing 590 event reports in physician offices (POLs), there were almost 1,000 testing errors, with almost 25 percent of these errors relating to reporting results to clinicians. Almost 13 percent of the 966 testing processing errors involved test ordering, while almost 18 percent were related to implementing the testing, including not performing the test at all, which was noted 6.7 percent in the study published in a recent issue of Quality and Safety in Health Care (2008;17;194-200).

The historic falls on Wall Street continued to impact the lab industry through late September and early October. For the week ended Oct. 17, 2008, the G-2 Laboratory Index was down 29 percent over the past five weeks and 30 percent so far in 2008. None of the 14 publicly traded labs tracked by the Index showed any growth over the past four weeks. In fact, all except one are down in the double digits compared to the previous four weeks. In addition, Nasdaq and S&P have yet to lift. The Nasdaq is down 36 percent, while the S&P 500 is down 36.38 percent so far in 2008.

The FDA’s concern over LabCorp’s marketing of its OvaSure ovarian cancer test appears to be intensifying. In a letter dated September 29, Steven Gutman, the FDA’s director of the Office of In Vitro Diagnostic Device Evaluation and Safety, warned CEO David P. King that the agency had conducted a review of the marketing and technical information available for the tests and concluded that there are "serious regulatory problems involving this device," and that regulatory action would be initiated if the premarket approval was not initiated to correct violations.