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FACTT Blood Test May Detect Cancer AIDS and Alzheimer’s Disease Early – Breakthrough Technology 100,000 Times More Sensitive than Current Tests

March 15th 2006

FACTT Blood Test May Detect Cancer AIDS and Alzheimer’s Disease Early – Breakthrough Technology 100,000 Times More Sensitive than Current Tests

Mark Green PhD

A new breakthrough technology may allow for early detection of some cancers, Alzheimer ’s disease, HIV and other deadly conditions.  The sensitivity of the test is 100,000 times higher than that of some other blood tests.  Another test, ELISA (enzyme-linked immunoadsorbent assay), is used as a diagnostic test to determine exposure to infectious agents, such as HIV, by identifying antibodies present in a blood sample.

The New FACTT (Florescent Amplification Catalyzed by T7-polymerase) test is much more sensitive.  One of the researchers, Hongtao Zhang, PhD, said "The current ELISA tests can only detect proteins when they are in high abundance. But the problem is that many of the functional proteins – those that have a role in determining your health – exist in very low amounts until diseases are apparent and cannot be detected or measured at early stages of medical pathology. It was important to develop a technique that can detect these rare molecules to detect abnormalities at an early stage."


Researchers at the University of Pennsylvania School of Medicine consider this a paradigm-shift in testing. The FACTT technology uses a different enzyme amplification system so that detection can be made from even a few protein molecules. 

The good part is that the technology is adaptable for any protein and can be performed in an automated format.  In fact the system will likely be robotized to even screen for rare disease causing proteins using tiny amounts of blood.  Senior author Mark I. Greene MD, PhD says "It is even possible that one could screen for multiple diseases at the same time and produce a precise accounting of whether disease-causing molecules are present at an early time when disease can be readily treated."


Since early treatment is better, this new test may save lives in the future.  In the lab, researchers implanted Her2/neu molecules into mice.  These molecules become over expressed in breast cancer patients.  They found that the current ELISA test was unable to detect Her2/neu in the mouse blood until the tumors became inoperable in size.  The FACTT technology was able to detect the molecules within a couple days of implantation, even before the tumors were barely visible.    

It was Greene’s team that established many of the principles of targeted therapy for Her2/neu tumors and the prototype antibodies that led to the development of Herceptin.  Trastuzumab (brand name Herceptin) was approved by the U.S. Food and Drug Administration (FDA) in 1998 for treating women with advanced (metastatic) breast cancer.  Since then it has also been used for early stage breast cancer as well.


The FACTT test will likely replace the complicated IHC (immunohistochemistry) and FISH (fluorescence in situ hybridization) for breast cancer. According to the researchers “A more sensitive assay could more accurately allow treatment of humans with breast cancer and allow treatment more quickly if the tumor reoccurs.”

Some doctors worry that the test being too sensitive.  It may cause patients to worry even though their condition may cure itself.  For example, some cancers are so small that the immune system can actually destroy and remove them automatically without you knowing it. 

On ABC World News Tonight, Dr. Eric Winer told Ned Potter "What we don't want to do is have a test that shows an abnormality, that detects the presence of a cancer cell, and will never matter to that woman."  Winer is director of the breast oncology center at the Dana-Farber Cancer Institute in Boston. "We have to be very careful that these tests are going to give us accurate information, and that they're not going to over diagnose and lead to over treatment and perhaps unnecessary treatment," Winer added. 

The test will likely be available in two or three years for routine use.  It will likely cost less than current tests and return results quicker.  FACTT will catch Her2/neu in 9 out of 10 women where the older ELISA test may be able to only detect the molecule in 2 on 10 samples.

The findings are published in the online version of Nature Medicine.   

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