200516-3 crc protect test report公司版 · • colorectal cancer (crc) is the second leading...

Test Report

Requisition Number

Patient Name

ID number

Date of Birth

Gender

Patient Phone Number

Patient E-mail

Name of Lab

Lab Phone Number

Name of Physician

Date of Collection

Date of Report

F M

Test Report

Order Information

: Taiwan : 台北市115南港區園區街3號18樓之一 USA : 1271 Oakmead Parkway Sunnyvale, CA 94085, USA : cellmaxlife.com

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If you have any questions, contact us to speak with a clinical specialist or get a referral to a doctor.

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Notes

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Patient Name:

Date of birth:

ID Number:


Test Report

Patient Test Result

Electronic Signatures

Score Range

Your Score

Recommendation

0~50LOW

51~75BORDERLINE

76~100HIGH

This test was developed and its performance characteristics determined by CellMax. Clinical decisions

regarding care and treatment of patients should not be solely based on this test. Not all disease will be

accurately detected. How this information is used to guide patient care is the responsibility of the

physician.

Copyright CellMax Life, 2014. All Rights Reserved

Comments

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Continue testing annually for your health and protection

Lab Supervisor

Yow-Sien (Daniel) Lin, PhD Date

Pathologist

Manana KvezereliJavey, MD, PhD Date


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Test Report

Methods And Limitations

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This test was developed and its performance characteristics determined by CellMax Life. Clinical decisions

regarding care and treatment of patients should not be solely based on this test. Not all disease will be

accurately detected. How this information is used to guide patient care is the responsibility of the physician.

These values were established by double-blind, case-controlled studies performed under IRB and were used to

validate the CMx Platform® performance. The normal reference range of this test is a Protect Score 0-50.

The CRC test is designed to assist health care practitioners in providing additional clinical information. The information therein should not be relied upon as being complete, nor should it be considered as inclusive of all proper treatments or methods of care or as a statement of the standard of care. Medical knowledge develops rapidly and new evidence may emerge between the time information is developed to when it is published or read.

CellMax Life provides this information on an "as is" basis, and makes no warranty, express or implied, regarding the information. CellMax specifically disclaims any warranties of merchantability or fitness for a particular use or purpose. CellMax Life assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of this information or for any errors or omissions.

The information herein is not continually updated and may not reflect the most recent evidence. The information addresses only the topics specifically identified therein and is not applicable to other interventions, diseases, or stages of diseases. This information does not mandate any particular course of medical care. Further, the information is not intended to substitute for the independent professional judgment of the treating physician, as the information does not account for individual variation among patients.

Test Result Interpretation

This result gives an indication that no colon disease was detected by the test. Annual testing is recommended.

This result gives an indication that additional clinical workup may be required. For more definitive diagnosis, results must be confirmed by a diagnostic test. It is recommended that you consult a physician for further guidance.

This result gives an indication that confirmatory diagnostic testing is needed. It is recommended that you consult a physician for further guidance.

Please note that CRC Protect detects disease in the colon, which can include inflammatory bowel disease, colitis, and others. Patients with such diseases are at a significantly higher risk of colorectal cancer and should be monitored with frequent testing.

LOW test result

BORDERLINE test result

HIGH test result

Patients with IBD or other

colonic disease


Test Report

Patient Risk Profile

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Risk Factors

Family history of CRC

IBD or other GI Tract disease

Smoking or alcohol consumption

Hypertension

Diabetes

Clinical Symptoms

Recent surgery

Blood in stool

Loss of appetite or weight loss

Systemic weakness / anemia

Abdominal pain, cramping or bloating


Typical Abnormal Cells

Typical Normal Cells

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CellMax CRC Protect® is a proprietary, clinically proven test that measures cellular biomarkers in a blood

sample. It can detect very small amounts of abnormal markers that could indicate presence of colorectal

disease. This test can also detect pre-cancerous polyps, early-stage and late-stage colorectal cancer.

Annual testing with this simple blood test is an effective and easy way for early detection of colorectal cancer.


Patient Name:

Date of birth:

ID Number:

About This Test

• Colorectal cancer (CRC) is the second leading cause of cancer-related death in the United States.

• More than 90% of colorectal cancer cases occur in people age 50 and older.

• Colorectal cancer incidence rates are 35-40% higher in men than women.

• Survival rate of CRC is highly dependent on when the disease is diagnosed:

o Early-stage disease has a 91% survival rate

o Late-stage disease has only an 11% five-year survival rate

• At initial diagnosis with current tests, over 50% of new CRC cases have already spread to other organs.

• Cancer is an evolving disease where early detection is key to overall survival.

• Routine and frequent testing is recommended to remain cancer-free.

Patient Name:

Date of Birth:

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Facts About Colorectal Cancer


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Risk Factors

Colorectal cancer can occur with or without the presence of any risk factors.

• Age

• Obesity

• Physical inactivity

• High fat diet

• Red meat diet

• Low fiber diet

• Diabetes

• Hypertension

• Smoking

• Alcohol consumption

• Family history of CRC

• Inflammatory bowel disease (ulcerative colitis, Crohn's

disease)

• Polyps in colon

• Previous history of colon polyps or colorectal cancer

• Previous history of radiation therapy for other cancers

• Family history of colon polyps or polyposis

• Family history of Lynch syndrome

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Other Conditions

Individuals with certain types of polyps and inflammatory bowel disease (Crohn's disease and

ulcerative colitis) are at an increased risk for colorectal cancer. More frequent testing can help

such individuals detect presence of potentially precancerous lesions or colorectal cancer.

Testing Saves Lives

Studies have shown that genetic mutations that lead to cancer can occur randomly, without the

presence of any other risk factors. The most effective way to prevent colorectal cancer is to get

tested regularly.


Patient Name:

Date of Birth:

ID Number:

Protecting Yourself From Colorectal Cancer

Colorectal cancer often derives from pre-existing colon polyps.

Regular testing is required, so that polyps can be detected and removed before they turn into cancer.

Since precancerous polyps or early-stage colorectal cancer may not show any symptoms, most individuals do not get tested until it is too late, and the cancer has progressed to a late stage.

Early detection of disease in the colon can be key to preventing colorectal cancer.

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Benefits of CRC Protect

Test Characteristics

• Highly sensitive and specific

• Detects precancerous lesions (e.g. adenomas)

• Equal detection ability of early as well as late stage CRC

• High quality control

For Patients

• Convenient blood draw

• Non-invasive

• No preparation required (e.g. bowel prep for colonoscopy, special diet for FOBT)

• No need for sedation

For Physicians

• Easy to order

• No need to deal with kits

• Interpretation is provided

• Give patients life-saving, actionable information


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Date of Birth:

ID Number:

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Causes of Colorectal Cancer

Majority of colorectal cancer is caused due to random mutations

• 75% of cases are sporadic

• 5-8% of all cases of CRC are hereditary

• 15-20% are “familial” / multifactorial

Hereditary nonpolyposis colorectal cancer (HNPCC) (5%)

Familial adenomatous polyposis (FAP) (1%)

Familial (10-30%)Sporadic (65%–85%)

Rare CRC syndromes (<0.1%)


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Characteristics of CRC

Characteristics of Hereditary CRC

• Multiple relatives with colorectal cancer

• One or more diagnosed at an early age (<50)

• Sequential generations affected (except in autosomal recessive

syndromes)

• Other cancers in the family known to be associated with CRC

(uterine, ovarian, GI)

• Multiple primary tumors or polyps present

Characteristics of Familial CRC

• Family history of CRC with no clear inheritance pattern

• Onset at age typical for sporadic CRC

• Few or no adenomas

• Colon cancer cases in the family (age> 50 at diagnosis) without

clear dominant pattern

• One close relative with CRC <60 years old

• Family history does not meet criteria for known hereditary CRC

syndromes

• Presence of multiple low penetrant genes in addition to

environmental factors

• Family members warrant earlier CRC screening

• Starting at the age of 40 or 5-10 years earlier than age of

diagnosis of the youngest affected relative

Characteristics of Average Risk


• No well-defined threshold between sporadic and familial CRC

at this time

• Probably safe to include individuals with:

o No personal risk factors or family history of CRC

o One 2nd or 3rd degree relative with CRC >60 years

with no other family history of CRC

Patient Name:

Date of Birth:

ID Number:

Risk Factors

: Taiwan : 台北市115南港區園區街3號18樓之一 USA : 1271 Oakmead Parkway Sunnyvale, CA 94085, USA

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: cellmaxlife.com

Non-Modifiable Risk Factors

Age

CRC risk increases with advanced age.

9 out of 10 people diagnosed with colorectal cancer are at least 50 years old.

Younger adults can also develop colorectal cancer.

Personal history of colorectal polyps

History of adenomatous polyps (namely numerous and/or large polyps) in colorectal region increases risk

of developing colorectal cancer.

Personal history of inflammatory bowel disease

Inflammatory bowel disease (IBD), which includes ulcerative colitis and Crohn's disease, is a condition in

which the colon is inflamed over a long period of time.

People with IBD for many years often develop dysplasia-abnormal transformation of colonic mucosa. The

latter can become a cancer over time.

Family history of colorectal cancer or adenomatous polyps

1 in 5 people who develop colorectal cancer have other family members diagnosed with CRC.

People with a family history of colorectal cancer in one or more first-degree relatives (parents, siblings)

are at increased risk.

One affected first-degree relative increases CRC risk twice.

The risk is even higher if that relative was diagnosed with cancer when they were younger than 45, or if

more than one first-degree relative is affected.

Racial and ethnic background

Asians (Taiwanese), African Americans, Ashkenazi Jews have high incidence and mortality rates from CRC.

Type 2 diabetes

People with type 2 diabetes have an increased risk of developing colorectal cancer and a less favorable

prognosis after diagnosis.

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Risk Factors


Lifestyle-Related/Modifiable Risk Factors

Many lifestyle changes can help reduce the risk of colorectal cancer.

Reducing alcohol intakeAlcohol use is a known risk factor for colorectal cancer, and risk increases as alcohol intake increases. If the patient chooses to drink, intake should be limited to no more than one drink daily.

Quit smokingSmoking is not just a risk factor for lung cancer, but for all digestive system cancers, including colorectal, stomach and esophageal cancers.

Increasing exerciseSedentary lifestyles are associated with an increased risk of digestive system cancers. Available research suggests that the most active adults have a 40 to 50 percent reduced risk of developing colon cancer, compared to the least active adults. Importantly, the protective effect of exercise appears to be independent of weight status, meaning that regular physical activity appears to reduce risk of colon cancer even in people who are overweight or obese.

Lose weightObesity is a strong risk factor for colorectal cancer, and researchers estimate that risk increases about 15 percent with each five additional points of body mass index beyond the upper end of normal range. So, for example, weight loss that results in a reduction of BMI from 35 to 30 would be expected to result in about a 15 percent risk reduction.

Eat less red meatThere is strong evidence supporting high intake of red meat as a risk factor for colorectal cancer. One large study that examined the diets of adults aged 50 to 71 showed that people with the highest intakes of red meat – an average of 5 ounces per day – had a 24 percent greater risk of developing colorectal cancer compared to those with the lowest intake – an average of about half an ounce per day.

Avoid processed/preserved meatsProcessed meats like bacon, salami and hot dogs are commonly preserved with sodium nitrite. When sodium nitrite encounters stomach acid during digestion, it may convert to a compound called a nitrosamine, which is a known carcinogen. Indeed, both high intake of nitrites and processed meats have been associated with increased risk of colorectal cancer compared to lower intakes.

Eat more vegetablesFruits and vegetables have a protective effect against colorectal cancer, likely as the result of a combination of factors that includes their antioxidant content, fiber and species-specific phytochemicals. Research has shown that people with diets highest in fruit and vegetables have lower risk of developing digestive system cancers (including colorectal) compared to people whose diets contain the least amount of these foods.

Get plenty of fiber in the dietFiber is non-digestible plant material that travels through the length of the intestines and arrives to the colon intact. Once there, it may trap dietary carcinogens in the stool, escorting them out of the body expeditiously before they have the chance to cause trouble.

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Date of Birth:

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Inflammatory Bowel Disease (IBD)

Individuals with IBD are at an increased risk

for colorectal cancer.

Most experts recommend people with IBD to

start having colon cancer screening early

and often. For some people, this might mean

having a colonoscopy eight years after being

diagnosed, and then once per year

thereafter.


Inflammatory Bowel Disease (IBD) is a group of disorders that cause swelling and inflammation in the

intestines, affecting as many as 3 million Americans. Often confused with Irritable Bowel Syndrome

(IBS), IBD refers to two chronic diseases: Ulcerative colitis and Crohn’s disease.

While Crohn’s disease and ulcerative colitis have common features, there are important differences.

Ulcerative colitis affects the lining of the large intestine (colon), causing it to become inflamed and

develop ulcers. Crohn’s disease, on the other hand, can affect any part of the gastrointestinal tract

and causes inflammation that extends deeper into the intestinal wall than with ulcerative colitis.

Crohn’s disease is a disease that causes inflammation or swelling, and irritation of any part of the

digestive tract—also called the gastrointestinal (GI) tract. The part most commonly affected is the

end part of the small intestine, called the ileum.

While ulcerative colitis tends to affect only the lining of the bowel, Crohn’s disease typically involves

the entire bowel wall.

Symptoms of IBD can include:

• Mild to severe diarrhea

• Abdominal pain

• Rectal bleeding, sometimes leading to anemia

• Fever

• Fatigue

• Weight loss, dehydration & malnutrition

• Possible delayed development

• Certain types of arthritis & skin disorders

Patient Name:

Date of Birth:

ID Number:

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Common Colorectal Cancer Symptoms

Some of the symptoms below, such as diarrhea or rectal bleeding, can be early warning signs of CRC in the general population.

• Hematochezia• Rectal pain• Diminished stool

caliber

Unique symptoms/signs and complications based on the tumor location

Cecal tumor Recto-sigmoid Tumor site

Symptoms/signs

Right sided (ascending colon)

Unrecognized iron deficiency anemia

Change in bowel habits

• Profound irondeficiency anemia.

• Fistula formationinto adjacent organs.

• Hematochezia (bright red stool)

• Melena (tarry stool)

• Abdominal pain

• Unexplained iron deficiency anemia

• Fatigue

• Change in bowel habits

• Narrow

• Weight loss

• Abdominal distention

• Nausea and vomiting

• fistula formation into adjacent organs

• Fever of unknown origin

• intraabdominal, retroperitoneal,

abdominal wall or intrahepatic

abscesses due to a localized perforated

colon cancer

CRC Symptoms & Complications

Typical symptoms Rare symptoms and complications


Left sided (descending and sigmoid)

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How to Prevent Colorectal Cancer


Healthy Diet

• Diets high in vegetables, fruits, and whole grains have been linked with a decreased risk of

colorectal cancer

• Fiber supplements do not seem to help

• Some cancers can be prevented by lifestyle and dietary changes

Alcohol

• Limit alcohol to no more than 2 drinks a day for men and 1 drink a day for women

Exercise

• Increase your physical activity level

Smoking

• Cutting out cigarettes now may help protect both you and your children from colon

cancer in the future

Get tested

• Screening should begin at age 50 for all “average risk” individuals or sooner if you have a

family history of colorectal cancer, symptoms, or a personal history of inflammatory

bowel disease or polyps

• Colorectal cancer can be prevented through regular screening and the removal of polyps

• Early diagnosis means a better chance of successful treatment

• Studies have shown that genetic mutations that lead to cancer can occur randomly,

without the presence of any other risk factors

• The most effective way to prevent colorectal cancer is frequent screening

Patient Name:

Date of Birth:

ID Number:

Test Report Disclaimer

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This test was developed and i ts performance character ist ics determined by Cel lMax L i fe . Cl in ical

decis ions regarding care and treatment of pat ients should not be sole ly based on th is test . Not a l l

d isease wi l l be accurately detected. How this informat ion is used to guide pat ient care is the

responsib i l i ty of the phys ic ian.

The Cel lMax L i fe test is des igned to ass ist heal th care pract i t ioners in provid ing addit ional c l in ical

informat ion. The informat ion therein should not be re l ied upon as being complete or accurate,

nor should i t be considered as inclus ive of a l l proper t reatments or methods of care or as a

statement of the standard of care. Medical knowledge develops rapidly and new evidence may

emerge between the t ime informat ion is developed to when i t i s publ ished or read.

Cel lMax L i fe provides th is informat ion on an "as is " bas is , and makes no warranty , express or

impl ied, regarding the informat ion. Cel lMax speci f ica l ly d isc la ims any warrant ies of

merchantabi l i ty or f i tness for a part icular use or purpose. Cel lMax L i fe assumes no responsib i l i ty for

any in jury or damage to persons or property ar is ing out of or re lated to any use of th is

informat ion or for any errors or omiss ions.

The informat ion herein is not cont inual ly updated and may not ref lect the most recent ev idence.

The informat ion addresses only the topics speci f ica l ly ident i f ied therein and is not appl icable to

other intervent ions, d iseases, or stages of d iseases. This informat ion does not mandate any

part icular course of medical care. Further , the informat ion is not intended to subst i tute for the

independent profess ional judgment of the t reat ing phys ic ian, as the informat ion does not account

for indiv idual var iat ion among pat ients .


Patient Name:

Date of Birth:

ID Number:

200516-3 crc protect test report公司版 · • colorectal cancer (crc) is the second leading...

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