PreGen-Plus™
DNA Test for Colon and Rectal Cancer
Private MD Lab Services offers a single test to help diagnose colon and rectal Cancer: PreGen-Plus™ Colorectal Cancer Detection.
What
is PreGen-Plus™?
PreGen-Plus™
is a non-invasive, DNA-based
test for colorectal cancer screening. Unlike other screening tests for colorectal
cancer, PreGen-Plus provides a sensitive, non-invasive and
easy-to-use option for the early detection of colorectal cancer, the second
leading cause of cancer-related deaths in the U.S. PreGen-Plus
is designed for the asymptomatic, average-risk population, aged 50 and older,
which according to the American Cancer Society, should be screened regularly
for colorectal cancer. PreGen-Plus
is not only breakthrough technology; it is the only non-invasive,
DNA-based test available for the detection of colorectal cancer. PreGen-Plus
isolates and analyzes DNA extracted from a client's stool sample
for alterations associated with the presence of colorectal cancer.
How
does PreGen-Plus work?
The client purchases the test online
at www.privatemdlabs.com and receives a collection kit via mail or commercial
carrier delivery to his/her own home.
The client then collects a single, whole
stool sample, and sends the sample to the laboratory using pre-paid packaging.
After analysis, test results are received
by Private MD Labs and posted to our secure Web site— the client logs on with
username and password for printing and viewing typically within two weeks.
Behind
the scenes at the lab:
The
human DNA from cells shed from the colon is extracted and then examined for
alterations. PreGen-Plus consists of a sophisticated panel
of 23 individual tests each looking for the presence of DNA alterations in
human DNA isolated from stool. Clients who receive a positive test result
indicating the likely presence of colorectal cancer will be referred on for
additional testing as medically appropriate, including colonoscopy. With a
negative test result, it is recommended clients continue their regular screening
program.
PreGen-Plus
differs from other available screening method. PreGen-Plus is:
Convenient—clients
can collect a single, whole stool sample in the privacy of their home. PreGen-Plus
does not require any special bowel preparation, stool handling or alteration
in diet or medications prior to testing.
Non-invasive—compared
to current screening methods like colonoscopy and flexible sigmoidoscopy,
PreGen-Plus only requires a stool sample for testing, and requires no handling
or sampling of fecal matter.
Sensitive—Based
on published studies to date, PreGen-Plus is comparable to other cancer screening
tests such as the Pap smear for cervical cancer.
How
sensitive is PreGen-Plus?
In
published studies to date, PreGen-Plus has demonstrated
a sensitivity of approximately 65 percent
and a specificity of approximately 95 percent. This point sensitivity is significantly greater than that of fecal occult
blood testing and comparable to other cancer screening tests such
as the Pap smear for cervical cancer. According to the American Cancer Society,
survival rates for colorectal cancer are greater than 90 percent if the disease
is detected early.
Additional Resources:
PreGen-Plus™ Step-by-Step Instructions (PDF)
Physician Letter (PDF)
What is colon or rectal cancer?
Colon or
rectal cancer is an abnormal growth of cells in the colon or rectum. Colon
cancer is the second leading cause of cancer-related deaths in the U.S. It
is important to diagnose and treat colon or rectal cancer as soon as possible.
If not treated, the cancer can spread through the bowel wall to lymph nodes
and the bloodstream and to other parts of the body.
Colorectal cancer is more common in countries where
obesity is common, where the diet is high in fat and low in fiber, and
where daily exercise is less common. It is not known how this combination
of obesity, diet, and lack of exercise combine to increase the risk for
colorectal cancer. Colon or rectal cancer usually occurs after age 50.
You have a greater risk of developing colon cancer
if you:
- have a personal or family history of colon
cancer, polyps, or inflammatory bowel disease
- have had uterine, ovarian, or breast cancer
- eat a high-fat and low-fiber diet.
What are the symptoms?
At first there are no symptoms. When symptoms do
occur they may include:
- visible blood in bowel movements (stools)
- constipation
- diarrhea
- a change in the shape, color, and frequency
of your bowel movements
- pain, discomfort, or sense of fullness
in the abdomen
- tiredness
- unexpected weight loss.
How is it diagnosed?
Your health
care provider will review your symptoms and examine your abdomen and rectum.
A sample of a bowel movement will be tested for the presence of blood. In
addition to PreGen-Plus, procedures called sigmoidoscopy
or colonoscopy may be used by your health care provider to look at the inside
of the colon and rectum. During a sigmoidoscopy or colonoscopy your provider
inserts a slim, flexible, lighted tube through your anus to view the inside
of your colon and rectum. Your provider may remove a small piece of tissue
that looks abnormal to examine and test for cancer (a test called a biopsy).
Colorectal cancer is common enough that colonoscopy after the age of 50 is
recommended as a routine screening procedure.
Another test you may have is a barium enema. In
this procedure fluid that contains barium is put into your colon. (Barium
shows up clearly on an x-ray film.) X-rays are then taken that show the
inside of your colon. If the x-ray images show a polyp or cancer, you will
need to have a colonoscopy to get a sample of tissue (biopsy) for lab tests.
How is it treated?
The tumor
and any organs or parts of organs that are affected by the tumor may be removed
with surgery. The surgeon will remove the section of colon or rectum that
contains the cancer and then rejoin the ends of the intestine. This procedure
is called resection and anastomosis. Another procedure,
called a colostomy, is necessary when the cancer is so near the anus that
there is not enough colon remaining above the anus after surgery to allow
the ends to be rejoined. In this case, the surgeon makes an opening in the
abdominal wall and passes the healthy end of the shortened colon through the
opening. The end of the bowel is attached to the skin. After this procedure
you will pass bowel movements through this opening. You will wear a colostomy
bag outside your body and under your clothes to collect bowel movements. You
will be taught how to manage the colostomy. In some cases the colostomy is
temporary and at other times it is permanent. You are much less likely to
need a colostomy if the cancer is diagnosed in the earliest stages.
Other possible treatments are:
- chemotherapy, which uses anticancer drugs
to kill cancer cells
- radiation therapy, which uses x-rays or
other high-energy rays to kill cancer cells and shrink tumors.
How long will the effects last?
If it is detected early, colorectal cancer may
be cured with surgery alone. In later stages, you may need additional treatment,
such as chemotherapy and radiation therapy, to reduce the risk of a return
of the cancer. Your health care provider may ask you to consult a medical
oncologist after surgery to determine whether treatment with chemotherapy,
called adjuvant treatment, is needed.
Your chance of cure depends on how far the cancer
has advanced. When a cancer is removed before it has spread into the wall
of the colon, more than 90% of people survive 5 years or longer. The chance
of survival decreases with advanced stages.
If you have a colostomy, your health care team
will help you adapt to living with a colostomy. Most people lead healthy,
active lives with colostomies. Your provider may suggest dietary changes
that restrict gas-forming and odor-causing foods such as beans, eggs, fish,
and carbonated drinks. In time, you will learn which foods you can tolerate
and which cause problems. You will be encouraged to return to full and
normal activities as you recover and learn to manage your colostomy.
How can I take care of myself?
Follow the treatment that you and your health care
provider determine. Seek the advice of other health professionals as needed.
In addition, maintain a lifestyle that allows you to:
- Get enough rest and sleep.
- Eat nutritious foods, following your after-surgery
diet instructions.
- Exercise according to your health care
provider's recommendations.
- Relax using techniques such as positive
mental imaging, muscle relaxation exercises, and diaphragmatic breathing
exercises. Seek enjoyable and humorous experiences to relieve stress.
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© 2005 McKesson Corporation and/or one of its subsidiaries. All Rights Reserved.
