New Approach to Genomic Testing Identifies Women With Low Risk of Breast Cancer Recurrence

- Exagen's Initial Validation Study Demonstrates Accuracy of Prognostic Tests

That Detect DNA Changes - With Application to All Patients -

Dec 13, 2004, 00:00 ET from Exagen Diagnostics, Inc.

    ALBUQUERQUE, N.M., Dec. 13 /PRNewswire/ -- An initial validation study
 presented by Exagen Diagnostics at the San Antonio Breast Cancer Symposium
 suggests it may soon be possible to distinguish good prognosis from poor
 prognosis in any newly diagnosed breast cancer patient based on DNA changes in
 the patient's tumor.  Those patients identified as having a very good
 prognosis may do well without chemotherapy or hormonal therapy after their
 tumors have been removed.
     In a retrospective study of 308 patients conducted with the University of
 New Mexico Cancer Research and Treatment Center at the Health Sciences Center,
 Exagen Diagnostics, an emerging leader in the rapid identification and
 productization of practical, genomic markers for prognostic testing, reported
 the discovery of two, 3-gene sets of markers that were prognostic in testing
 archived specimens from hormone receptor (HR)-positive and hormone
 receptor-negative patients, respectively.  These two sets of markers form a
 panel for use in testing tumor tissue from breast cancer patients, providing a
 same- or next-day result.
     In independent test sets, each of the 3-gene markers accurately identified
 91 percent of HR-negative and HR-positive specimens from patients that did not
 experience recurrence of disease.  In patients that were also node negative,
 the negative predictive value was 100 percent (e.g., 100 percent of patients
 identified by these tests had a good prognosis clinically).
     The study population consisted of white and Hispanic patients with
 invasive ductal carcinoma that were diagnosed between 1986 and 1999 at the
 University of New Mexico Health Sciences Center.  A minimum of four years of
 follow-up clinical information was available for each of the patients, with an
 average follow-up of 8.9 years.  Poor prognosis was clinically defined as
 development of recurrence, as evidenced by either distant metastasis or death
 from breast cancer.  Good prognosis was clinically defined as the absence of
 recurrence (or death from breast cancer) as of the last date of follow-up.
     "With this approach, we are seeking to define a new standard of care by
 becoming the first company to offer a prognostic panel of tests that examines
 the patient's tumor tissue to detect changes in DNA copy number in any
 patient.  This is a more practical method than currently available tests using
 RNA," said Waneta Tuttle, Ph.D., Exagen CEO.
     "Today, we are treating almost any woman as though her cancer is
 aggressive, which puts patients who don't actually need treatment at risk for
 side-effects of therapy that is not necessary," explains Ian Rabinowitz, M.D.,
 the primary UNM clinician involved in Exagen's initial study.  "For early
 stage breast cancer there are about 70 to 80 percent of patients who are
 cancer-free and don't actually require therapy after they receive a
 lumpectomy.  At this point in time, we have no way of identifying which
 patients fall into that category.  So, the advantage of a technology such as
 Exagen's prognostic tests, once it is further validated, is that we can better
 identify patients that have a very good prognosis and potentially don't
 actually require therapy," he said.
     The study was conducted using a proprietary "pattern of genomic
 amplification" FISH (e.g., fluorescent in situ hybridization) test or PGA
 FISH(TM).  Due to the small number of markers in each reagent set, Exagen is
 uniquely able to implement these tests with PGA FISH technology, making them
 readily usable by any FISH-testing laboratory.  Exagen's discovery technology
 is based on a mathematical approach that enables the company to examine
 25,000 genes with no "preference" for one gene over another to define the
 best, small combination of genes for a specific testing purpose.
     About Exagen Diagnostics, Inc.
     As an emerging leader in prognostic testing, Exagen Diagnostics is
 uniquely able to define small sets of genomic markers that are more accurate
 than other approaches, whether for breast cancer, infectious disease or other
 indications.  Exagen's proprietary discovery and implementation technologies
 enable the rapid identification and productization of optimized DNA or RNA
 genomic marker sets for prognostic or predictive testing, either for
 diagnostic testing by reference laboratories or for pharmaceutical R&D
 purposes.  For more information, visit

SOURCE Exagen Diagnostics, Inc.