Here - Dr. Apsley

advertisement
The ONCOblot Test
Early Detection – Laboratory Developed Test (LDT)
CLIA Accredited – CAP Accredited
The ONCOblot® Test is a highly sensitive blood test for cancer. It identifies the presence
of cancer as well as the organ site of origin through the detection of ENOX2 proteins.
Provides early cancer detection: The ONCOblot® Test can detect the essential ENOX2
protein associated with cancer before clinical symptoms appear. The ENOX2 protein
species in the blood is unique to malignant cells and these proteins can be detected at
the earliest stages of development.
Reveals origin of ENOX2 protein according to tissue or organ: The ONCOblot® Test
reveals the tissue of origin of the ENOX2 protein which in turn your physician uses to
identify the exact kind of cancer arising:












Lung
Liver
Breast
Prostate
Colon
Bone
Skin
Blood
Lymphatic
Pancreatic
Ovarian
Cervical
Provides accurate information your physician may use to render the proper diagnosis:
The ONCOblot® Test identifies the ENOX2 markers that are only produced by cancer
cells and absent from non-cancer cells. The direct visualization of a marker presence
eliminates false positives.
Delivers value: ONCOblot® does the work of more than 10 tests normally costing $100
to $200 each, none of which directly detect ENOX2.
The test must be prescribed by a physician.
How the ONCOblot® Test Works
What is the test based on?
The ONCOblot® Test identifies a specific type of protein, ENOX2, which exists only on
the surface of a malignant cancer cell. The ENOX2 proteins are shed into the circulation
and can be detected in the blood. These proteins serve as highly sensitive markers for
your physician to make an accurate early detection in both primary and recurrent
cancer. The test is a valuable complement to early intervention.
How sensitive is the test?
The ONCOblot® Test is highly sensitive. It will detect ENOX2 proteins when only 2 million
cancer cells are present compared to 4.5 trillion cells for a positive mammogram.
How does the test determine organ site?
The ONCOblot® Test uses techniques known as two-dimensional gel electrophoresis
and western blot analysis along with an ENOX2 protein-specific antibody for detection.
The result is presented visually on the ONCOblot®. Each type of ENOX2 has a specific
location (molecular weight and isoelectric point) on the blot to demonstrate ENOX2
presence and to identify the organ site.
What are the steps involved for the ONCOblot® Test?
• Test kit delivered to physician
• Blood drawn (may be performed at local clinical laboratory) and sent to ONCOblot®
Labs
• Approximately 2 week testing period
• Results sent to physician
How is the ONCOblot® Test used?
• Initial screening of patient
• To help discover recurrence
• Familial cancer screening
• On-going screening during cancer treatments
Laboratory-Developed Test (LDT):
ONCOblot® is a laboratory developed, CLIA-registered blood serum test that meets
current FDA guidelines.
Early Trial Results:
Midcourse evaluation in November 2011 of 100 subjects enrolled in an early detection
trial revealed the following trends:
• Of 92 subjects presenting with no clinical symptoms, 56 subjects or 60% were negative
in the ONCOblot® test.
• Of the same 92 subjects presenting with no clinical symptoms, 36 subjects or 40% were
positive in the ONCOblot® test. This aligns with current data of 1 in every 3 individuals is
expected to contract cancer in their lifetime.
• Of the 36 subjects with markers testing positive for early stages, 12 were identified by a
physician as non-small cell lung cancer, 7 as breast cancer, 6 as lymphoma/leukemia, 1
each for ovarian, melanoma, prostate and colon, and 7 having transcript variants not
yet in the database.
Insurance Reimbursement:
Currently, Medicare and insurance carriers do not cover ONCOblot® testing since the
test is so new. However, ONCOblot® is being evaluated by insurance carriers for
reimbursement and may in the near term offer coverage. So stay tuned!
Download