Source MDx Validates Molecular Diagnostic Test to Improve the Diagnosis of Prostate Cancer as Compared with PSA Testing Alone, Showing the Potential to Reduce Need for Biopsies

- Data supports using blood RNA transcript tests to more accurately diagnose
prostate cancer with great cost savings potential for the healthcare system-
ORLANDO, Fla.--(Business Wire)--
Researchers from the Dana-Farber Cancer Institute and Source MDx presented at
the annual meeting of the American Society of Clinical Oncology (ASCO) results
from a large study demonstrating that the company`s whole-blood based six gene
test plus PSA significantly improved diagnostic accuracy for prostate cancer
when compared with age-adjusted prostate specific antigen (PSA) alone. In the
two year prospective study of 484 men, the six-gene test plus PSA demonstrated
sensitivity and specificity greater than 90% in discriminating prostate cancer
patients from healthy normal subjects. Earlier studies suggest that the
conventional PSA test is 60-70 percent accurate in detecting cancer.. More
accurate diagnoses of prostate cancer could potentially lead to substantial
healthcare savings from a reduction in the more than one million prostate
biopsies that are negative for cancer in the US, currently estimated to cost
over $2 billion annually.

"This test potentially represents part of the solution to the current healthcare
crisis by both improving patient outcomes and lowering costs to the healthcare
system," stated Karl Wassmann, Chief Executive Officer of Source MDx. "We are
finalizing a multicenter clinical trial of 1,000 men, planned to begin in
several months, and are currently discussing potential commercial licensing of
this, the first of our family of prognostic, predictive and early detection
oncology tests, with leading diagnostic companies."

This study builds on the strength of Source MDx`s approach to developing a
family of molecular diagnostic tools for prostate cancer. The Precision Profile
diagnostic test for prostate cancer uses whole blood to measure RNA transcripts
for six cancer and immune related genes. A previous study at the ASCO
Genitourinary Symposium in February, also presented by Dana-Farber researchers,
demonstrated that another Source MDx diagnostic test predicted survival in men
with castration-resistant prostate cancer, suggesting a potential tool to better
stratify patients by aggressiveness of disease.

The study, conducted by the Dana-Farber Cancer Institute, was presented by Drs.
William Oh, M.D., clinical director, Lank Center for Genitourinary Oncology,
Dana-Farber and Robert W. Ross, M.D., attending physician, Lank Center for
Genitourinary Oncology, Dana-Farber, in a poster (Abstract #5052), at ASCO on
May 31, 2009.

"Early detection of prostate cancer is essential for effective intervention, yet
the low specificity of current screening methods grossly overestimate the
presence of prostate cancer, leading to substantial patient anxiety and pain
associated with unnecessary biopsies," commented Dr. Ross. "These results
suggest that this test, when used together with PSA screening, may provide a
powerful diagnostic tool for prostate cancer leading to a reduction in
unnecessary biopsies."

"These results demonstrate proof of concept that specific RNA transcript levels
can assess abnormal gene expression levels associated with untreated, localized
prostate cancer, and play an important role in the development of a diagnostic
tool," stated Dr. Oh. "I am looking forward to further evaluating this test on a
larger scale in a multi-site trial."

Study Details:

The study looked prospectively at 484 men from August 2006-October 2008. The men
were divided into three groups: those newly diagnosed with localized, untreated
prostate cancer; healthy normals; and otherwise healthy normals with BPH. These
men were randomly assigned to either a training or validation study group.
Beginning with a pool of 174 candidate genes, the researchers identified a six
gene test with a high degree of sensitivity in predicting prostate cancer
(88.2%) and specificity in identifying healthy normal patients (85.5%) from a
training patient group of 76 prostate cancer patients and 76 healthy normal
subjects. These results were confirmed in a larger validation study group of 128
prostate cancer patients and 94 normal healthy subjects, showing sensitivity in
predicting prostate cancer of 85.9% and specificity in identifying healthy
normals of 83.0% (P < 0.001).

Sensitivity and specificity were significantly improved when PSA was
incorporated into the six gene test. In the training set, sensitivity and
specificity improved to 97.4% and 96.1%, respectively. This improvement was
confirmed in the validation group, which demonstrated sensitivity and
specificity of 87.2% and 92.6%, respectively (p<0.001). The inclusion of BPH
patients into the training and validation study groups reduced specificity to
91.5 and 91.4%, respectively but did not have a significant effect on
sensitivity. When the training and validation groups were combined and
reanalyzed with the combined six gene test plus PSA, sensitivity and specificity
were improved to 93.6% and 94.7% respectively.

About Prostate Cancer:

Prostate cancer is the most common cancer, other than skin cancers, in American
men and is the second leading cause of cancer death in men behind only lung
cancer. The American Cancer Society estimates that during 2008 about 186,320 new
cases of prostate cancer will be diagnosed in the United States. Treatment
options include active surveillance, hormone therapy, chemotherapy, and
radiation.

About Source MDx:

Source MDx is developing and commercializing prognostic, predictive and early
detection molecular diagnostic (Precision Profile) assays and tests for cancer
and other inflammatory diseases. The Company's lead development programs, in
collaboration with the Dana-Farber Cancer Institute, include a family of
Precision Profile assays for prostate cancer designed to: improve early
diagnosis with a goal to reduce the need for biopsies, predict the
aggressiveness of the cancer, better define prognosis and more effectively
stratify patients for drug response - all of which may serve to improve the
management of patient care and lower healthcare costs. The Company is also
developing molecular diagnostics in collaboration with other leading academic
medical centers in a range of cancers, including lung and melanoma, as well as
certain inflammatory and autoimmune diseases such as multiple sclerosis. Source
MDx's patented assays and tests measure RNA-transcript-based gene expression in
whole blood using quantitative PCR, optimized for clinical use in a commercial
setting. The Company has a multi-year translational molecular medicine
collaboration with Pfizer to develop and validate RNA-based pharmacodynamic and
predictive biomarkers within Pfizer's cancer and inflammation therapeutic
development programs. Learn more at: www.sourcemdx.com.

Media:
Linnden Communications
Michelle Linn, 508-362-3087
michelle@linndencom.com

Copyright Business Wire 2009