Digene, Ivax Diagnostics, Myriad Genetics, Bioscientia, LabOne, Aetna

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IN MEXICO, Rotary International will attack the problem of cervical cancer among Mexican women by supporting a screening program that utilizes human papillomavirus (HPV) testing.

Called “Test for Life,” the program will be run by local Rotary clubs in Mexico and the United States. It is funded by a grant from the Rotary Foundation and targets women in urban and rural areas who are currently underserved by existing cervical cancer screening and treatment services. The program’s first two clinics are expected to become operational this summer.

There are several intriguing aspects to this program. “Test for Life” will primarily use Digene Corporation’s Hybrid Capture® 2 HPV DNA test, not conventional Pap smears, to screen for cervical cancer. Also, the Cleveland Clinic Foundation will use data generated by “Test For Life” as the basis for a clinical study.

One noteworthy feature of “Test For Life” is patient self-collection. Digene’s Chairman and CEO, Evan Jones, stated that “an important aspect of this program is that it marks the first broad-based use of a self-collected cervical cancer screening test.”

The “Test for Life” program in Mexico demonstrates how developers of new diagnostic technologies continue to look for clinical utility in countries where health services are less well-developed. Digene’s efforts in Central America and Southern Africa have been reported earlier by THE DARK REPORT.

This program also follows the strategic product launch example of Cytyc Corporation. When it introduced its ThinPrep® thin-layer Pap smear test, Cytyc was careful to cultivate the support of women’s health advocates. During various stages of the approval and acceptance process, women’s health advocates played a valuable role in arguing for acceptance of thin-layer Pap smear testing by clinicians and payers. Digene would obviously like to gain that same kind of support, once it can demonstrate acceptable performance of its HPV test in the “Test For Life” program in Mexico.


WITHOUT MUCH FANFARE, the lab industry gained a new publicly-traded diagnostics company early this spring.

The “newborn” is Ivax Diagnostics, Inc., based in Miami, Florida. It was formed by a merger of the diagnostic business subsidiary of Ivax Corporation and b2bstores.com, Inc., an Internet-based company that decided there was more future in a “real” business like diagnostics.

Ivax Diagnostics had sales of $11.8 million during 2000. Its three operating subsidiaries are: Diamedix Corporation, which manufactures diagnostic kits that can be run either manually or on its MAGO® instruments; Immuno-Vision, Inc., which develops and manufactures autoimmune reagents and research products; and Delta-Biologicals S.r.l., based in Parmezia, Italy, which developed and manufactures the MAGO instrument and sells its products to labs in Italy.

Under the leadership of President and CEO Giorio D’Urso, Ivax Diagnostics concentrates on the immunoassay market and offers a variety of test kits built upon ELISA technology. Its Mago instrument is an automated solution that is designed to be “load and walk away.” Ivax intends to stay focused on specialty immunoassays.


IN ANOTHER EXAMPLE of an American-based diagnostics company doing business overseas, Myriad Genetics, Inc. announced a testing agreement with Bioscientia Ltd., based in Ingleheim, Germany.

Bioscientia will collaborate with Myriad to offer its family of BRAC-Analysis® predictive tests in Germany, Switzerland, and Austria. Bioscientia is a large lab, capable of performing esoteric tests and handling more than 12 million tests annually.

Under terms of the agreement, Bioscientia will send test specimens for analysis to Myriad’s laboratory in Salt Lake City, Utah. Myriad will transfer “technical know-how for site-specific mutation detection to Bioscientia.”


ON JULY 6, A PORTLAND, OREGON JURY tagged LabOne, Inc. with a $400,000 compensatory damage award in favor of Yasuko Ishikawa, a Delta Airlines flight attendant.

It’s a case that demonstrates the slippery ground concerning certain aspects of drugs-of-abuse testing. Delta had terminated Ms. Ishikawa based on a LabOne report of “test not performed–specimen substituted.” The low creatinine in Ms. Ishikawa’s specimen triggered the report. Ms. Ishikawa has since been rehired by Delta.

LabOne was caught by implementation timetables for bureaucratic rulings. The Department of Health and Human Services (DHHS) had issued Program Document 37 (PD) 37 on July 28, 1999 calling for labs to report creatinine results “to one decimal point beyond a whole number rather than to the whole number.” PD 37 did not specify an implementation date for laboratories to comply.

LabOne performed the test on Ms. Ishikawa’s specimen in September 1999, using the whole number reporting method. Like many other labs, it implemented the change to decimal point reporting required by PD 37 in January 2000. Ms. Ishikawa’s attorneys successfully argued that, had LabOne fully implemented PD 37 in September 1999, her sample would not have been reported as substituted.


ALTHOUGH A NUMBER of big managed care companies are reporting improved finances, Aetna, Inc. continues to operate in the red.

The company has declined to provide earnings guidance for the balance of 2001, a sign of financial uncertainty. Most financial analysts are predicting that Aetna will again lose money in second quarter 2001.

One big issue is underpricing of insurance premiums. “They took their eye off the ball,” stated Oliver Marti, Portfolio Manager at Columbus Circle Investors. “As a result, they underpriced their business.”

Also, Aetna’s HMO medical cost ratio soared to 90% in the first quarter, compared to 85.9% in second quarter last year. To stem the outflow, Aetna is reviewing sources of leakage, increases in medical costs, how patients are using healthcare, and how medical claims are processed.


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