WASHINGTON _ Biotechnology companies clearly are stationedon the front lines in the war against cancer if the last four days of theannual meeting of the American Association for Cancer Research(AACR) are any indication. The thick book of abstracts distributed atAACR is chock full of preclinical and clinical data usingbiotechnology-based compounds, from South San Francisco-basedGenentech Inc.'s humanized HER2 antibody against breast cancer(now in Phase III trials) to the dizzying array of potential genetherapies that are mostly but a blob in a test tube or a gleam in ascientist's eyes.

But even as biotechnology companies are pushing the envelope oftechnological innovation, they also are pushing some hot ethical andsocietal buttons. On Wednesday, Myriad Genetics Inc.'s vicepresident of research, Mark Skolnick, unveiled new details of hiscompany's plan to provide genetic susceptibility testing services forthe BRCA1 breast and ovarian cancer gene starting later this year.Some scientists and ethicists have expressed doubts about genetictesting, challenging its clinical value for diseases for which there areno effective therapies. A positive test for a BRCA1 gene mutationcould mean a woman's risk of developing breast or ovarian cancer isdrastically increased.

OncorMed Inc., a Gaithersburg, Md.-based company, has beenoffering BRCA1 gene screening since mid-1995. Salt Lake City-based Myriad is set to ratchet up the competition via its diagnosticarm, Myriad Genetic Laboratories Inc. According to Skolnick,Myriad will offer roboticized full sequence-based tests of patients'genes in its facilities and will subject all samples to eight differentverification tests before registering a positive test. Myriad will offerits testing services only to physicians and not directly to patients andall patients will sign informed consent documents before undergoingtesting.

OncorMed currently employs a variety of testing technologies,including sequencing as well as more cost-effective methods. Allgenetic testing at OncorMed is done under the auspices ofinstitutional review board-approved protocols.

Skolnick said his company will charge about $1,000 to test the firstmember of a given family for a BRCA1 mutation. The testing of at-risk relatives will be less expensive because the exact mutation beingsought will be known. According to Leslie Alexandre, spokeswomanfor OncorMed, BRCA1 testing can range anywhere from $150 to$1,200 at her firm, depending upon the type of test used and whetherthe test is for a first family member or a relative.

Although both Myriad and OncorMed focus on providing theirtesting services only to the population of women who are truly at-riskfor carrying a mutant BRCA1 gene (namely women who have hadfamily members die of breast or ovarian cancer or Ashkenazi Jews),some critics have said that genetic testing presents these women withdreadful choices. For example, some women have opted to haveprophylactic double mastectomies or oophorectomies (ovaryremovals), even though it has yet to be conclusively proven that suchmeasures actually prevent the development of cancer. But Skolnickdisagreed with that view.

"The idea that we shouldn't screen people for these genes becausethere is nothing we can do for them is nonsense," said Skolnick at anAACR press conference on Wednesday. He noted that even the cost-conscious health maintenance organization Kaiser Permanente hasdecided to offer BRCA1 screening to select individuals andreimburse for the costs. "Breast and ovarian cancer are veryamenable to preventive therapies," he said.

However, Paul Billings, a medical geneticist from StanfordUniversity, in Palo Alto, Calif., called for "unbiased"epidemiological studies to support the hypothesis that currentprophylactic measures available to women at risk are trulyefficacious.

"The rush to genetic testing for breast cancer should be tempered,"warned Billings. "Very little useful knowledge can be gained fromthese tests and by focusing on one or two genes in the cascade ofcancer biology, we are ignoring other genes and environmentalfactors that likely play an important role in the development of cancerin individuals." n

-- Lisa Piercey Special To BioWorld Today

(c) 1997 American Health Consultants. All rights reserved.