PreGen-Plus DNA Test for Colon and Rectal Cancer

LabsMD offers a single test to help diagnose colon and rectal Cancer: PreGen-Plus™ Colorectal Cancer Detection.

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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 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 LabsMD 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:

What are the symptoms?

At first there are no symptoms. When symptoms do occur they may include:

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:

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:

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