“State of Industry” Report On Molecular Diagnostics

Firm releases its first national survey of labs now performing molecular testing

CEO SUMMARY: Enterprise Analysis Corporation has launched an ambitious survey that will include 150 laboratories performing molecular testing in the United States. Last week it released information about the first 51 labs contacted in this effort. The survey provides an intriguing look at what molecular tests laboratories are performing in the areas of infectious diseases, genetic diseases, coagulation/hematologic, and cancer.

MOLECULAR DIAGNOSTICS is still in its infancy. There is much speculation about the experience of early-adopter laboratories now performing such testing because few studies on this subject have been conducted.

To bring clarity to this situation, Enterprise Analysis Corporation (EAC), a healthcare consulting company based in Stamford, Connecticut, has initiated a comprehensive national survey. The goal of this survey is to collect information from as many as 150 laboratories currently performing molecular testing.

Preliminary Findings

EAC released its preliminary findings at the American Association of Clinical Chemistry (AACC) meeting last week in Philadelphia. “To date, we’ve contacted 51 laboratories now performing molecular diagnostic testing,” stated Mark Hughes, Senior Consultant at EAC. “Each laboratory answered questions about the types of testing they perform, along with volumes, methods, and equipment. Their answers give us an early look at the ‘state of the industry’ for molecular diagnostics.”

The survey is gathering information about four areas of molecular diagnostic testing. They are: infectious dis- eases, genetic diseases, coagulation/ hematological disorders, and cancer. Survey results from the first 51 laboratories reveal an interesting picture.

First, the average number of molecular diagnostic tests performed annually at these 51 labs is growing steadily, at the rate of 14% in 2002 and 15% for 2003. Of the 51 laboratories surveyed to date, 50% offer between six and 15 assays in their molecular labs, while 22% offer between 16 and 25 different assays.

In the infectious disease category, it is no surprise that Chlamydia was the most frequently performed assay. Thirty of the surveyed labs offer it, and their annual mean volume was 57,768 and the annual median volume was 7,000. Second and third highest volumes were HIV quantitative and HCV quantitative, with an annual median volume of 3,000 and 800 respectively.

In genetic diseases, Cystic Fibro- sis testing was done at 12 labs, with a median annual volume of 500 tests. Fragile X is done at 11 laboratories, with a median annual volume of 250 tests.

Factor V Leiden is the leading molecular diagnostic test in the coagulation/hematologic category, with 25 labs performing this assay. The median annual volume is 800 tests. Next is Prothrombin II, performed at 23 labs, with a median volume of 600 tests.

In the cancer category, EAC reports gene rearrange (bcl-1, bcl-2) as the most frequently performed test. Eighteen labs offer it, and the median annual volume is 240 tests. Second and third on the cancer test list are Her2/neu (eight labs) and BCR-ABL (15 labs), with median annual volumes of 120 tests and 118 tests respectively.

Survey of Methods

PCR is the most frequently used method, with 90% of the surveyed labs utilizing it. A majority of molecular laboratories, 80%, perform home brew assays, while 41% of the laboratories work with ASR-based assays (analyte-specific reagents).

Not surprisingly, EAC found Roche to be the leading vendor in the molecular diagnostics field, with 68% of surveyed labs reporting at least one Roche assay on their molecular test menu. Next was Bayer, with 41% of the labs using at least one assay, followed by Digene (37% of labs), and Gen-Probe (33% of labs).

“Four common issues in molecular diagnostic testing were identified from the survey,” stated Hughes. “First, molecular labs want better automation solutions. Current methods are considered to be quite labor intensive and too slow. Second, both the recruiting and the training of qualified personnel is a challenge.

“Third, it was often stated that reimbursement levels for molecular tests are low,” he added. “Fourth, bud- get constraints and the lack of resources was mentioned.”

Those interested in tracking the progress of this survey can reach EAC at www.eacorp.com. This report on the responses from the first 51 molecular diagnostic laboratories surveyed provides a useful look at how early-adopter laboratories are establishing their molecular testing programs.

EAC’s Key Findings About Molecular Testing

IN JUNE AND JULY 2003, Enterprise Analysis Corporation (EAC) conducted telephone interviews with 51 laboratories that maintain active molecular diagnostic programs. Key findings are listed below.

  • Survey included 51 molecular diagnostic laboratories:
  • 46 hospital-based
  • 4 private laboratories
  • 1 military/armed forces lab

Survey covered these disciplines:

  • Infectious diseases
  • Genetic diseases
  • Coagulation/Hematological
  • Cancer

Key Findings:

  • Molecular diagnostic labs perform an average of 15 different molecular assays.
  • Overall average volume is 4,400 tests per year.
  • Test volume increased 14% in 2002.
  • 76% added new assays in the past 12 months.
  • 80% plan to offer additional assays in the next 12 months.
  • Home brew methods still used in 80% of surveyed laboratories (for at least one type of test).
  • ASRs growing in popularity, with 41% of surveyed labs using at least one ASR.
  • Roche is the dominant vendor, with 68% of surveyed labs

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