"Lab Industry Briefs"

Myriad Genetics, LabCorp, Abbott Labs, OraSure,TheraSense

DIRECT-TO-CONSUMER ADS FROM MYRIAD GENETICS TO START THIS FALL

FOLLOWING THE EXAMPLE of the pharmaceutical industry in using direct-to consumer advertising to build drug sales, Myriad Genetics, Inc. is about to launch an advertising campaign for its predictive genetics tests.

Beginning this fall, consumers in Denver and Atlanta will see a television, print, and radio campaign touting the benefits of Myriad Genetics’ BRAC- Analysis® test for breast and ovarian cancer. These will be the first-ever ads which promote genetic testing directly to the public. A number of healthcare policy experts are concerned about how these ads may impact the public.

Direct-to-consumer advertising is just one aggressive step Myriad Genetics is taking to promote its diagnostic tests. Last December, the company announced an exclusive marketing agreement with Laboratory Corporation of America. Under the agreement, LabCorp’s 600 sales reps will market Myriad’s tests for assessing the genetic risks of breast, ovarian, colon, uterine, and skin cancers.

Not only is Myriad Genetics breaking new ground with its plans to market genetic screening tests directly to the public, but it is an example of how swiftly the old market channel for new diagnostic test technology is disappearing.

Traditionally, a manufacturer would send its sales reps directly to commercial laboratories to educate them about the test. With the help of the manufacturer’s reps, the local lab would market the new tests to clinicians in the area. As more clinicians began to order the test, many hospital labs would then set up the test and offer it as well.

Myriad’s market strategy is based on using LabCorp’s clout and market reach as a primary method to contact office-based clinicians to educate them about these diagnostic tests. LabCorp paid Myriad an upfront fee for “the right to market Myriad’s products, and technology and rights to perform mutation detection tests.”

Smaller regional laboratory competitors and hospital laboratory outreach programs don’t have the money to pay upfront fees for the right to introduce a new test which has yet to achieve widespread clinical acceptance. As a result, one consequence of this approach to launching a diagnostic test will be to exclude smaller labs early in the market introduction cycle.

ABBOTT AND ORASURE INK DEAL INVOLVING RAPID HIV TEST

GIVEN THE POLITICAL SENSITIVITIES surrounding the availability of a rapid test for HIV-1 and HIV-2 in the United States, one way to read Abbott Laboratories’ agreement to co-distribute OraSure Technologies’ OraQuick® rapid HIV-1 is that Abbott hopes this small step will help it gain favor with certain federal healthcare regulators.

The new agreement calls for Abbott Labs to distribute the OraQuick rapid HIV-1 test to hospitals and physicians’ office laboratories. OraSure will distribute the test to public health facilities and the criminal justice system.

In exchange for up-front fees and ongoing royalties paid to Abbott, Orasure also receives a sublicense for non-exclusive rights to use certain lateral flow patents held by Abbott. Lateral flow technology allows a sample to flow through a test strip and show a test result at the downstream end of the strip.

As disclosed earlier in THE DARK REPORT, health officials within the Centers for Disease Control (CDC) and the U.S. military would like a rapid test capable of detecting both HIV-1 and HIV-2. However, Bio-Rad Laboratories holds a patent on HIV-2, which is sublicensed to Abbott, Chiron, and Ortho-Clinical Diagnostics. (See TDR, January 7, 2002.)

The licensing agreement used by Bio-Rad requires that each licensee approve the extension of licensing rights to additional companies. Each licensee manufactures an HIV-2 test performed in complex laboratories. To date, they have yet to authorize use of the HIV-2 patent in a rapid HIV test.

Since the CDC and the military have been publicizing their desire for a rapid test for combined HIV-1 and HIV-2, this new agreement between Abbott and OraSure may be to establish a working relationship that eventually leads to sublicensing the HIV-2 patent to OraSure for its version of a combined rapid HIV test.

THERASENSE CLEARS FDA WITH PDA-BASED GLUCOSE MONITORING

HERE’S AN INTERESTING clinical application for the Palm-Pilot type of PDA (personal digital assistant) device.

TheraSense, Inc., based in Alameda, California, reported on June 14 that it had received clearance from the Food and Drug Administration to begin selling its FreeStyle Tracker diabetes management system for the Handspring™ Visor™ PDA.

“We incorporated the blood glucose monitoring technology from our Free-Style monitor into a module for the HandSpring Visor PDA,” declared Mark Lortz, President and CEO of TheraSense.

The FreeStyle Tracker System allows a diabetic patient “to test for glucose levels and get a read-out on the PDA screen, graph and chart the results over time, review carbohydrate food lists to track their food intake, create reminders about testing or dietary choices and more.” The patient can also download and transmit this data to physicians, giving them a time-stamped progression of blood glucose levels, as well as management actions taken by the patient.

THE DARK REPORT observes that this type of patient self-test device points to the growing sophistication of consumers. Manufacturers of point-of-care testing devices are investing considerable resources to accomplish two goals. First, they are teaching consumers how to manage their condition, using the diagnostic device in a clinically appropriate manner. Second, these devices allow a patient to feed lab test data back to clinicians in a timely and accurate fashion.

At current sales rates, TheraSense will book more than $120 million in revenues for 2002. This shows how fast the patient self-test market for blood glucose is growing. This opens up new opportunities for traditional laboratory organizations. But it will require lab administrators and pathologists to “think out of the box” for ways to add value to clinicians.

For example, labs should consider developing a diabetic test and management program that supports physicians treating diabetics. One intriguing aspect would be to capture the blood glucose test data generated by patient self-testing and add that to the clinical repository. Since both physicians and payers want access to that kind of information, there should be ways for labs to generate revenue from that type of information.

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