Data From Clinical Study of bioTheranostics Molecular Diagnostic Test Presented at...

Data From Clinical Study of bioTheranostics Molecular Diagnostic Test
Presented at American Society of Clinical Oncology Annual Meeting

- THEROS CancerTYPE ID(R) predicts cancer origin with 75 percent accuracy in
patients whose primary cancer was 'unknown' using traditional diagnostics -

SAN DIEGO, June 1 /PRNewswire/ -- bioTheranostics, a bioMerieux company that
discovers, develops and commercializes new molecular diagnostic tests in
oncology, announced that a recent study demonstrated the company's THEROS
CancerTYPE ID(R) molecular diagnostic test predicted cancer origin with 75
percent accuracy in patients whose primary cancer was initially "unknown"
using traditional diagnostics. Findings were presented today at the 2009
American Society of Clinical Oncology (ASCO) Annual Meeting in Orlando, Fl.

Three to five percent of all cancer patients(1) (the equivalent of
45,000-75,000 new patients each year in the United States alone) receive a
diagnosis of cancer of unknown primary origin, or CUP, meaning their cancer
has spread to multiple locations and the site where the cancer started can not
be determined. Given that the origin of a cancer significantly impacts
physicians' therapeutic decisions as well as patients' prognoses, the
inability to diagnose patients' primary cancers makes it more difficult for
physicians to determine optimal treatment plans. Molecular diagnostic tests
such as the THEROS CancerTYPE ID have demonstrated the ability to predict the
origin of tumors with a higher success rate than traditional diagnostic tests,
thereby helping to reduce the number of cancers that remain "unknown".

The blinded study involved 28 patients who had an unknown primary cancer that
was subsequently identified during their lives. Researchers assessed tissue
from these patients' initial biopsies, determining that 20 of them were
appropriate for testing with the THEROS CancerTYPE ID (eight were excluded
given insufficient tumor tissue or poorly preserved RNA). Without accessing
other clinical or pathological data for these patients, the team then compared
the THEROS CancerTYPE ID cancer type predictions to the actual primary sites
previously identified for each patient.

Among the 20 samples that were appropriate for testing, 15 site-of-origin
predictions (75 percent) provided by the THEROS CancerTYPE ID test were
accurate based on the actual clinical diagnoses. In contrast, traditional
diagnostic methods often fail to properly diagnose unknown cancers even after
extensive work-up that could cost up to $18,000.(2)

"Cancers of unknown primary origin present unique and significant challenges
to both medical professionals and patients," said Richard Ding,
bioTheransotics chief executive officer. "As the clinical validity and utility
of molecular diagnostic tests such as the THEROS CancerTYPE ID continue to be
demonstrated in clinical studies, we are eager to work with the oncology and
pathology communities to integrate molecular diagnostic tools into routine
cancer diagnosis."

The abstract, "Unknown Primary Cancer (UPC): Accuracy of Tissue of Origin
Prediction by Molecular Profiling" is available online at the ASCO Web site,
www.abstract.asco.org.

About bioTheranostics

bioTheranostics discovers, develops and commercializes molecular diagnostic
tests for cancer patients. Leveraging its unique expertise in genomic
profiling and proprietary algorithms, bioTheranostics provides innovative
tests to the oncology community that help drive personalized treatment. The
company operates a CLIA-certified, CAP-accredited diagnostic service
laboratory in San Diego, CA to perform its proprietary molecular diagnostic
tests: THEROS CancerTYPE ID(R), a molecular cancer classifier particularly
helpful for patients diagnosed with primary or metastatic cancer where the
origin is uncertain or unknown; and the THEROS Breast Cancer Index(SM), a
combination of THEROS H/I(SM) (HOXB13:IL17BR) and THEROS MGI(SM) (Molecular
Grade Index) that refines and improves risk stratification in patients with
estrogen receptor (ER)-positive, lymph-node negative breast cancer. More
information is available at www.bioTheranostics.com.

(1) N. Pavlidis, E. Briasoulis, J. Hainsworth, F.A. Greco. Diagnostic and
therapeutic management of cancer of an unknown primary. Euro J of Cancer.
2003; 39:1990-2005.

(2) D. V. Schapira and A. R. Jarrett. The need to consider survival, outcome,
and expense when evaluating and treating patients with unknown primary
carcinoma. Arch Int Med. 1995; 155.

Contact: Michele Parisi
925/429-1850
mparisi@biocommnetwork.com

SOURCE bioTheranostics

Michele Parisi of bioTheranostics, +1-925-429-1850,
mparisi@biocommnetwork.com