Roche, Digene, Centrex,, Specialty Labs, Tripath Imaging


HEIGHTENED CONCERNS over bioterrorist attacks have accelerated plans within the public health lab sector to acquire state-of-the art diagnostic technology in DNA typing and enzyme immunoassay.

Roche Diagnostics has instrument systems well-suited for both testing categories. Its DNA analyzers will compete with systems from Applied Biosystems and Cepheid. Major competitors in the immunoassay field will be PerkinElmer and Applied Biosystems.

The Center for Disease Control and Prevention (CDC), along with state and local public health labs, is accelerating long-standing plans to incorporate speedier methods of detecting bioterrorist attacks. The goal is to replace conventional testing methods for such organisms as anthrax and plague with molecular and DNA-based technologies that are faster and offer increased sensitivity.

The CDC is currently working to validate molecular DNA and antibody tests for organisms and molecules most likely to be used in bioterrorist attacks. Its goal is to supply state public health labs with identical kits of reagents necessary to identify bioagents. This would allow faster and more accurate analysis to be done. It would also create common capabilities so that, if needed, results can be verified at other labs.


EFFORTS TO ESTABLISH HPV TESTING as an accepted part of clinical protocols for cervical cancer detection continue at Digene Corporation.

As noted in past issues of THE DARK REPORT, Digene has studied the marketing methods used by Cytyc Corporation to successfully introduce thin-layer Pap tests into the healthcare community. One technique used by Cytyc was to position its thin-layer product as enhancing women’s health.

Digene is following that same path. In Belgium’s Parliament, the Chamber of Representatives has “approved unanimously a resolution calling for the introduction of human papillomavirus (HPV) testing within a national cervical cancer screening program.”

Digene is hoping that this resolution, and similar pronouncements by authoritative organizations, will help create public pressure for health systems to incorporate HPV testing into their accepted clinical procedures.


THROUGHOUT THE SUMMER, lab portal companies competed intensely to win the contract to implement browser-based lab test ordering and results reporting at Centrex Clinical Laboratories, Inc. of New Hartford, New York.

In September, Centrex awarded the contract to Implementation of the new system is already under way. Some of the first sites are already live.

Centrex has a reputation for being an early adopter. Just two years ago, it became one of’s first customers and one of the first hospital-owned commercial lab companies to implement browser-based lab test ordering and results reporting. (See TDR,February 14, 2000.) However, McKesson now only supports for use as part of its integrated information product suite designed for multi-hospital health systems. This forced Centrex to look for another vendor, which turned out to be

Among the emerging lab portal companies, has begun to establish its credibility. Earlier this year, Diagnostic Laboratories, Inc. of Honolulu, Hawaii and PathLab, Inc. of Portsmouth, New Hampshire (now owned and operated by Laboratory Corporation of America) selected for browser-based lab test ordering and reporting.

Sources also tell THE DARK REPORT that has the inside track to sell its browser-based ASP system to one of the major health system labs in New York City. It’s a signal that more laboratories believe the physicians’ office marketplace is becoming comfortable with the concept of browser-based lab test ordering and reporting.


ALTHOUGH SEPTEMBER was a turbulent month for the entire laboratory industry, Specialty Laboratories, Inc. seems to have taken it in stride.

For third quarter, it reported total accessions had increased 16% over the same quarter last year. Net revenue for the quarter was $42.8%, an increase of 8.3% and net income was $2.9 million, up by 22.4%.

This strong increase in specimen volume indicates that, despite economic doldrums in other sectors of the economy, demand for esoteric and reference testing remains strong. Clinicians continue to order sophisticated tests as an integral part of their practice.

Because of disruptions in the national air transport system following the events of September 11, it might be expected that national esoteric labs like Specialty would have experienced a flat or declining volume of accessions. Since that was not the case, the logistics response by Specialty’s management team seems to have sustained the incoming flow of specimens.

In fact, at 1:30 a.m. on Thursday morning of that tragic week, Specialty’s Lifeguard flight, a FedEx charter, was the first plane to land at Los Angeles International Airport (LAX) since its closure at 9:00 a.m. on September 11.Specialty told THE DARK REPORT that, for the entire week, specimen volume was only down 15%.


AFTER A LENGTHY EFFORT, TriPath Imaging, Inc. finally obtained clearance from the Food and Drug Administration (FDA) to market its automated thin-layer preparation system and automated Pap screening system as an integrated product.

The FDA’s clearance, announced October 8, makes TriPath Imaging the first company to offer a totally-automated solution for preparing, then screening, thin-layer Pap tests. Just nine days later, MDS Laboratory Services of Canada signed an agreement to acquire and use TriPath’s automated Pap test system. MDS does about 500,000 of Canada’s four million Pap smears yearly.

TriPath Imaging was formed from the merger of AutoCyte, Inc. and NeoPath, Inc. in the summer of 1999. It has worked continuously since the merger to obtain clearance from the FDA to marry its automated PREP® system with AutoPap®, its automated screening system.


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