310
in Danish patients who were treated with chemotherapy after removal of breast
cancer tumors. That study used data from tumor samples and clinical data from 767
patients with high-risk tumors, and it confi rmed that the test was useful in estimat-
ing recurrence and survival in women who had received chemotherapy. Dako
received the CE mark for the test in 2007 and has since launched the assay in Europe
and in the US.
Prognostic Tests for Breast Cancer
A study has demonstrated that a history of hypertension, ER/PR status, HER2 sta-
tus, metastasis-free interval, metastatic location (including brain, bone and liver),
and BMI at diagnosis with metastatic breast cancer were the most relevant prognos-
tic factors for survival after diagnosis of metastatic disease (Jung et al. 2012 ).
Findings of this study may form a foundation for the growing body of knowledge
explaining the outcome differences in treatment of patients with metastatic breast
cancer, potentially helping to create tailored counseling and personalized treatment
approaches for this vulnerable group.
Prognostic testing of all patients prior to treatment aligns with standard medical
practice to distinguish patients by hormone status. This information also enables
pharmaceutical companies to clearly defi ne patient stratifi cation for improving clin-
ical trial timelines and outcomes.
Exagen’s Breast Cancer Prognostic Marker Assays These are the fi rst and only
tests to enable specifi c testing for hormone receptor (including estrogen receptor
and progesterone receptor) positive and for hormone receptor negative patients
using an improved FISH assay. These prognostic tests separate patients with good
prognosis from those with poor prognosis by testing each patient’s tumor tissue to
detect changes in DNA (e.g. gene copy number) in order to directly refl ect changes
in the tumor. Exagen’s prognostic tests are uniquely developed as separate sets of
DNA markers to identify prognosis in hormone positive and hormone negative
patients, respectively. Both marker sets represent the fi rst prognostic tests that can
be used by any FISH-testing laboratory, enabling fi t of this testing approach with
standard hormone testing prior to treatment. Exagen’s small, prognostic marker sets
combine to form a testing panel that differs from other existing sets of 20- to 70-gene
markers by enabling:
- Use of improved FISH technology with a small (3–5) number of probes to fi t
with current laboratory testing practices and equipment; - Testing of all breast cancer patients to provide additional prognostic information
based on hormone receptor status (including estrogen receptor and progesterone
receptor) prior to treatment; and - Detection and visualization of tumor-based cellular changes to defi ne only those
DNA changes that are specifi c to tumor tissue.
10 Personalized Therapy of Cancer