ONC gets approval:
Wednesday December 31, 11:30 am Eastern Time
Company Press Release
FDA Approves Oncor INFORM HER-2/neu Breast Cancer Test
First U.S. Gene-based Cancer Recurrence Indicator Requires No Extra Exam or
Surgery
GAITHERSBURG, Md.--(BUSINESS WIRE)--Dec. 31, 1997-- Oncor Inc. (AMEX:ONC -
news) announced today that the U.S. Food and Drug Administration (FDA) has
approved the new Oncor INFORM(TM) HER-2/neu breast cancer test. This is the
first time the FDA has approved a gene-based test for prediction of cancer
recurrence. Oncor will shortly begin manufacturing and marketing the
INFORM(TM) HER-2/neu test.
According to the American Cancer Society, breast cancer is the most common
form of cancer among women with more than 180,000 cases found in the United
States each year. While two-thirds of patients are initially told that the
cancer has not spread, more than 40,000 women annually will find that the
cancer has come back -- usually in a more aggressive, fast-spreading form.
The challenge is for the oncologist and patient to take all available
information about the patient's disease and identify customized therapy
that will be most effective.
Using the readily available original breast cancer tissue sample, the Oncor
INFORM(TM) HER-2/neu test identifies the presence or absence of increased
copies of the HER-2/neu gene. This indicates whether or not breast cancer
is likely to return. This information could help the 40,000 women each year
who face a high risk for recurrence get a head start in determining how
they will deal with the disease. In clinical trials, 31 percent of patients
with originally localized breast cancer that had a positive HER-2/neu test
died within five years of surgery, while 97 percent of patients with
negative test results survived at least five years. Conventional detection
procedures must wait until the disease recurrence is present, allowing the
cancer to advance before treatment begins.
''If you're born today, your chances of getting cancer in your lifetime are
one in three,'' said Stephen Turner, chief executive officer of Oncor.
''That means that cancer is a health problem that statistically every
American family is going to have to deal with. All of us share a need for
new technology that is going to define the exact, molecular basis for this
cancer, and therefore bring in new types of treatment.''
The Oncor test is not limited to newly found breast cancer. Because the
test is applied directly to breast cancer cells, cancer survivors can ask
their doctors to perform the test on the paper-thin tissue samples that are
often kept on record -- even if the tissue samples are many years old. In
virtually all instances, the HER-2/neu test can be conducted without the
patient going to the doctor's office for an additional examination or
surgery.
''Cancer genetics is an exploding area in clinical research,'' said Jeffrey
S. Ross, M.D., chairman, Department of Pathology, Albany (N.Y.) Medical
Center, who participated in the clinical trials for the Oncor test. ''The
amplification of the HER-2/neu gene predicted which women would have a
higher risk of relapse, and which women were more likely to die of the
disease. The HER-2/neu test is designed to provide additional information
to the patient and her oncologist. That is why Oncor calls the test the
INFORM(TM) HER-2/neu gene detection system.''
Oncor CEO Turner added, ''The INFORM(TM) HER-2/neu test is the first of
what we believe will be many molecular tests from Oncor to help provide
more information to doctors and patients, enabling them to make more
knowledgeable decisions when deciding treatment options for cancer.
''This is a very gratifying day, one which marks the beginning of a new era
of molecular medicine. The hard work of FDA personnel, the dedication and
commitment of the entire Oncor team, and the support of our shareholders
have combined to produce a powerful new medical technology. The lives of
our wives, daughters and grandchildren will be better because of this FDA
approval.''
Oncor Inc. (http://www.oncor.com) develops, manufactures and markets
gene-based test systems and related products for use in the detection and
management of cancer and other human disease.
This press release contains statements of a forward-looking nature
regarding future events. These statements are only predictions and actual
events may differ materially. Please refer to documents that Oncor files
from time to time with the Securities and Exchange Commission for a
discussion of certain factors that could cause actual results to differ
materially from those contained in the forward-looking statements.
---------------
Contact:
Oncor Inc.
Stephen Turner, CEO
Cecil Kost, COO
Patrick Muraca, director, Diagnostic Programs
Bernie Tyrell, VP, Sales & Marketing
301/963-3500
E-mail: ir@oncor.com
or
Media Contact:
John Chuhran, 212/564-4700 |
