New DNA Colorectal Cancer Home Test

Surprise, surprise. Within a day of finishing an update on colorectal home tests in the last blog, the feature article of the New England Journal of Medicine (NEJM) related to a new DNA-based stool test for colon and rectal cancer. It wasn’t that long ago when DNA-based stool colorectal cancer home tests were mostly replaced by what was considered more reliable blood-based fecal immunochemical tests (FITs). Despite this, it was continued to be advised that screening tests for colorectal cancer include DNA markers. The NEJM reports on study of a home test that takes into consideration both blood and DNA markers and claims a level of sensitivity approaching colonoscopy, widely considered the gold standard for colorectal cancer screening.

Developments over the past few years of more sensitive and faster DNA analytic methods, have allowed for production of this novel multiple target test. The test, called Cologuard, is produced by Exact Sciences of Madison, Wisconsin.  Based on the data from the NEJM study, an advisory committee to the Food and Drug Administration (FDA), on March 27, 2014 in a 10 – 0 vote, recommended pre-market approval of the test. The panel considered the noninvasive test to be safe and effective with the benefits outweighing any possible risks.

ScreeningBloodBlood + DNA
Sensitivity - Colorectal cancer74%92%
Sensitivity - Advanced pre-cancers24%42%
Sensitivity - High Grade Polyps46%69%
FDA ApprovalYesLikely
Cost~$15Significantly Higher

The current study involved almost 10,000 individuals of average risk for colorectal cancer in 90 sites throughout the U.S. and Canada. All study participants underwent a colonoscopy and Cologuard and PolyMedco FIT tests. The DNA-based test had a sensitivity of 92%, in that it correctly identified 92% of individuals with colon cancers as well as 69% with high-grade polyps as verified by colonoscopy findings.

Although Exact Sciences had proposed that Cologuard be considered an adjunctive colorectal screening test to FIT, members of the FDA Molecular and Clinical Genetics panel expressed excitement with the study results, with some suggesting that it replace current FITs. Although the Molecular and Clinical Panel’s recommendations still needs to be reviewed by the FDA, approval is widely anticipated.

Jacob J Klausner

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Home Tests Detect Colon Cancers

It’s been over a year since we last covered stool tests for colorectal cancer. As March is colon cancer awareness month in the US, let’s look at some more recent developments in home screening tests.

For several years now, it’s been recommended by the American Cancer Society and the Centers for Disease Control and Prevention that individuals of average risk who are between the age of 50-75 years, have yearly screening tests for colon-rectal cancer. Studies indicate  that 90% of colorectal cancers occur in those over the age of 50. Nevertheless it is advised that Native Americans and African-Americans begin screening at age 45. Studies investigating effectiveness of such tests have reported varying accuracy in detecting hidden or occult blood.

A study just published in the Annals of Internal Medicine, reviewed the quality and results of 19 investigations that had been published in the past 17 years utilizing 8 different fecal immunological tests (FITs). This study concluded that FITs are able to detect about 4 out of 5 patients with colorectal cancers, i.e. they have a sensitivity of 79%. In addition, FITs are 94% accurate in ruling out patients who do not have colorectal cancer.

FITs may be administered at home or at the doctor’s office and are considered to be superior to older fecal occult blood tests (FOBTs). Whereas FOBTs require prior diet and medication modification and multiple specimens to be sent to a laboratory, second generation FITs allow for single samples and provide results in a minutes. As of now, the FDA has approved the test distributed by the Pinnacle BioLabs and which can be purchased directly for $15 as well as some retail pharmacies. The company is also working on having two major retailers distribute the test.

FITs are capable of detecting blood originating from the lower GI versus blood from the stomach or the upper GI. While a positive FIT test could indicate colon or rectal cancer, it may also reflect Crohn’s Disease, irritable bowel disorder, colitis or diverticulitis. A positive FIT test should always be reported to a physician and may require a colonoscopy for a more definitive diagnosis.

Colon and rectal is estimated in 2013 to be the third most common cause of cancer deaths in both men and women in the U.S, following lung cancer and prostate or breast cancer respectively. For this reason, in addition to yearly FIT testing, it is recommended that individuals of average risk in this age group, undergo a colonoscopy every 10 years and an interim lower colon sigmoidoscopy every 5 years. It’s also advised that individuals of increased risk, such as those with either a family history or a past history of polyps, may be screened even earlier and  more frequently.

While most adults are aware of a 10 or 5-year time frame for a colonoscopy, few know that yearly screening is also recommended. More simplified and reliable home tests that entail single samples that do not need to be sent anywhere for results, increase the likelihood that more people will comply with strongly suggested screening recommendations.

Factors Which Increase Risk For Colon Cancer

* Cigarette smoking

* Alcohol usage

*   Lack of exercise

*   Obesity

*   Red meat diet

*   Fatty diet

*   Low fiber diet

*   Prior polyps


Jacob J. Klausner

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Crowd Diagnosing of Medical Illnesses

Internet technology has touched all our lives. Though not all changes are viewed positively, in the area of dissemination of health information, the internet has been without a doubt – revolutionary.

Take for example the San Francisco start-up company CrowdMed launched in the Spring of 2013. Four years in the development and planning stages, this internet site attempts to link individuals with medical conditions that defy clear diagnosis with the opinions of clinicians and non-clinicians throughout the world. In other words, it attempts to employ ‘the wisdom of crowds’ to solve the most difficult medical cases that exist or simply provide a second opinion.

The more common or basic medical ailments can usually be quickly diagnosed and treated by most practitioners. But there are individuals who experience concurrent conditions, rare illnesses, or ailments that are rare to a specific locale and therefore defy easy diagnosis. These and other type of situations can make it very difficult establishing the correct diagnosis and proper treatment. This is especially the case in geographically remote areas where only the most basic medical services are available.

It is has been reported that approximately 8 percent of the world’s population, or a total of 350 million people, experience one of 7,000 rare or very difficult to diagnose conditions. Furthermore, many new conditions are discovered yearly, making it very difficult for most busy clinicians to keep up.

The way CrowdMed works is you first register on line as either a patient or a medical detective (MD). As a patient, information related to symptoms, health history, family health history, medications, lifestyle is posted by opening a case with a $50 refundable payment. In addition, diagnostic laboratory results and imaging findings can be downloaded. Also the patient can be asked further questions or you can discuss the case with other participants. The patient also indicates if and how much they are offering as a cash reward for the best diagnosis. This is decided by the patient or their physician ninety days after the posting or when 50 MDs have provided input, whichever is first. Rewards are distributed to the Medical Detectives based on their point scores for the case.

Medical detectives are enticed to register, as they may view providing feedback, a fun exercise or intellectually challenging. There is also the prospect of entering a competition or a betting contest with the reward being either cash or earned points that leads to a charitable donation on behalf of the most astute MDs. The charitable contribution apparently comes from 10% of the award proceeds retained by CrowdMed.

To date, CrowdMed has raised over $2.3 million in venture capital and claims to has saved an estimated $7.8 million in traditional medical expenses in solved and pending cases. The Medical Detectives of CrowdMed have in the short time since launch, have relieved immeasurable suffering for those patients who have participated and may even have saved some lives.



  • Private beta phase testing with real patients proved to be “stunningly accurate”
  • Utilizes patented diagnoses prediction market technology
  • Accurately lists the most probable diagnoses
  • Provides second opinions easily
  • Potential for curtailing unnecessary diagnostic procedures and treatments
  • Doesn’t require the hassle of another clinician visit
  • Saves time and money in seeing a clinician.
  • Leads to proper treatment sooner
  • Eliminates individual clinician’s bias, lack of knowledge or experience.
  • Addresses privacy concerns.



  • Site is not yet widely known
  • Buy in by clinicians still remains
  • False hope for desperate patients


Jacob J. Klausner

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Bio-Nano-Chips Reveal Epilepsy Drug Levels

Imagine that you need to regularly go to a laboratory to have your blood drawn to determine the level of a medication you’re taking. Now imagine a new alternative and all you need to do is provide some saliva in the comfort of your home. Apply the saliva to a smaller than a credit card size disposable piece of plastic that contains a biologically sensitive nano-chip and the level of the medication is determined within seconds.

No need to imagine any further. Researchers at University of Texas Houston have just released findings that demonstrate this to be realistic for two anti-convulsant medications commonly used in treating epilepsy.

At the 67th Annual meeting of the American Epilepsy Society in Washington D.C., Dr. Giridhar P. Kalamangalam presented data (Platform A.09/Abstract 1750229) related to the anti-convulsant drugs phenytoin and phenobarbital. In a limited pilot study, they demonstrated that the measurements attained from these small programmable bio-nano-chips (BNCs) equate with measures from laboratory serum testing, considered to be the gold-standard. Kalamangalam calls these BNCs ”labs on a chip” that had first been developed in a Houston laboratory, the JT McDevitt Research Laboratory at Rice University.

Major Benefits of Bio-Nano- Chip Drug Testing
- Cost Effective – Approximately $3 / BNC
- Non-invasive
- Rapid Results
- Convenient Administration
- Performed in remote areas lacking easy access to traditional laboratories

Individuals with epilepsy need to maintain their anti-convulsant medication within a therapeutic level to avoid experiencing seizures when the medication levels drops. This necessitates frequent checks on the anticonvulsant levels, but with utilization of BNCs drug adjustments should be able to be made immediately.

The Houston researchers in collaboration with bioengineers, are aiming next to develop a portable battery operated portable scanner that can be used at home to read the BNC disc and provide drug level results using saliva samples. Aside from medications, the BNCs may have the potential of detecting DNA, proteins, cells and other chemicals of life.

Photo demonstrates relative size of BNCs

Photo demonstrates relative size of BNCs

It is estimated that currently there are about 50 million people throughout the world and 3 million in the U.S., who experience various types of epileptic seizures. Epilepsy is believed to be the third most common neurological condition, following Alzheimer’s and stroke. There is no doubt that further developments in BNC technology have the potential of leading to significant medical cost savings.


Jacob J. Klausner

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Repeated Recalls Impact Home Testing by Diabetics in 2013

Just when we thought we were finished this year with recalls of blood glucose home testing devices and supplies, a new one surfaced last week.

This most recent recall pertains to certain lots of Abbott glucose test strips that provide incorrect low readings of blood glucose levels. As a result, the patient may be inclined to adjust their glucose management, thinking that their low glucose levels need to be raised, when they may already be higher than normal, resulting in hyperglycemia.

Abbott has announced the recall in the United States of of 20 lots of FreeStyle and FreeStyle Lite Blood Glucose Test strips. These test strips produce erroneous results only when used with the company’s FreeStyle Blood Glucose Meter and FreeStyle Flash Blood Glucose Meters, which were last manufactured in 2010. Also impacted in the recall is the OmniPod Insulin Management System. The same strips when used with newer test devices, reportedly produce correct glucose measurements.

The expiration dates for the Abbott test strips are between May 2014 and March 2015 and their lots are listed.


John Wilkinson, director of medical devices at the British Medicine and Healthcare Products Regulatory Agency is quoted as saying “While three lots of the test strips have been affected by the manufacturing fault this problem has been resolved and there is no evidence that any patients in the UK have been adversely affected by the faulty test strips” He advises that people who have FreeStyle Lite Blood Glucose Test Strips “should continue to test their blood sugar but should be mindful that they could give a misleading low reading.” In the U.S., Abbott  has notified anyone possessing strips with affected lots to call Abbott’s diabetes care customer service at 888-736-9869 and arrange for replacement of the strips at no cost.

During the summer, Nova Diabetes  announced a recall of 21 lots of their Nova Max Glucose Strips. These totaled 62 million strips that had been distributed in the U.S., Canada, Chile, Peru, Argentina, Dominican Republic, Jamaica, United Kingdom, Belgium, Finland Congo and Saudi Arabia. In contrast to the Abbott strips, Nova Max strips resulted in false high glucose measurements.

Here is a list of the effected test strip lot numbers.


The company has requested that those with the affected strips, call 800-682-7390 to request replacement of the recalled item. Alberto Gutierrez, director of the FDA’s  Center for Devices and Radiological Health said that “It is important that patients using these test strips discontinue their use immediately”.

Incorrect blood glucose readings are not limited to the glucose strips. Last Spring, Abbott’s FreeStyle InsuLinx Blood Glucose Meter, experienced a software glitch that resulted in erroneous low glucose readings being displayed and saved. Such false readings have the potential of delaying treatment for hyperglycemia and may have serious adverse health consequences.

Recommendations When Testing Blood Glucose at Home

- FDA advises that glucose testing should not be interrupted, even if only defective test strips are available.

- When opening a new vial of test strips, a sample control test strip should be used to verify the quality of the new strips. If the resulting readings are not within the suggested range, the strips should not be used.

- If results are inconsistent with historic glucose readings for the individual, then the test should be repeated using strips from another vial.

- If results remain inconsistent with historic glucose readings after being repeated, contact should be made with the healthcare provider.

- Regardless of the consistency of test results, if the individual feels the results are not accurate or they do not feel well, then contact should be made with the healthcare provider.

- The individual should make no adjustment in their diabetes management based solely on the strip results without input from their healthcare provider.

With these recent reports of inaccurate glucose readings due to glucose strips or software issues, a brief review symptoms that result from low and high sugar may be useful.

Symptoms of Hyperglycemia (High blood glucose)
- Feeling Excessively Thirsty
- Blurred Vision
- Excessive Urination
- Nausea, Vomiting or Stomach Pain
- Feeling Weak

Symptoms of Hypoglycemia (Low blood glucose)
- Sweating Excessively
- Feeling Hungry
- Trembling
- Feeling Weak
- Headache
- Feeling Confused
- Seizures
- Unconsciousness

 Despite these recent recalls of home glucose testing supplies, there is no doubt that testing glucose levels at home is of major help to patients and providers in maintaining blood glucose levels within the proper range for longer periods of time. But we can’t forget, when the consequences are so great, that equipment can malfunction and errors occur in the manufacturing of supplies.

- Jacob J Klausner

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Self-test for Strep Throat

As temperatures outside begin to dip and as another winter approaches, we again face the onset of a new cold and flu season. While most people will experience a sore throat with the common cold which is of viral origin, others will experience a sore throat from bacterial infection (Group A streptococcus), which can lead to more debilitating symptoms.

The confusion for most people with sore throats relates to the similarity of symptoms with a sore throat of viral and bacterial origin. This makes it difficult to establish an accurate diagnosis without a visit to a clinician. After clinical examination and reference to agreed upon guidelines, no confirmatory testing may be needed or treatment required. As a result, patients often find themselves in a quandary, unsure whether to spend the time and money to seek further medical care.

To address this problem, investigators at Harvard Medical School have looked into the use of a home tool to assess the likelihood that the sore that is of bacterial origin, warranting further treatment. They have found that by combining several factors into a simple measurement instrument, it is possible to accurately do so. They considered symptoms such as coughing, runny nose, hoarseness and ear pain and concluded the most predictive symptoms of a sore throat of bacterial infection are:

• Fever
• Absence of coughing
• Age – Older than 15
• Recent local incidence of strep. throat

A major benefit to this tool is that it does not depend on any medical knowledge or the need for physical examination by either the patient or clinician. There is no need to feel if the throat lymph nodes are swollen or if the tonsils are draining. Instead of such examination findings, the home score substitutes data of recent levels of confirmed streptococcus infections in the community. It is claimed that the instrument determines the risk of strep. throat with the accuracy that approximates a clinician’s examination.

A Strep A home test provides for self-triage and the following advantages.

• Reduces unnecessary visits to clinicians
• Reduced need for confirmatory throat culture or streptoccal DNA testing
• Reduces unnecessary prescribing of antibiotics
• Reduces bacterial resistance to antibiotics
• Reduces disruption of normal bacterial population and side effects
• Reduces medical care costs

Currently, there are several obstacles to more widespread utilization of this home strep. First, the home tool is not applicable to children under 15 years of age who are more likely to experience strep. throat and are aggressively treated. The main issue with its utilization in adults is that clinicians and individuals do not have ready access to recent data of streptococcus infection in the community. It’s assumed that most hospitals and large practices already have access to data to allow them to calculate their own incidence rates. It is further anticipated that with increased conversion to electronic medical records as well as more consumer oriented technology with its medical apps and web-based personal medical portals, this will become a non-issue. Until then, personal knowledge of local strep. throat incidence and the symptoms listed above can serve as to guide, though an incomplete guide, in assessing low risk of strep. throat in adults.

- Jacob J. Klausner

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Issues With Home Coagulation Tests

For the past several years, it has been estimated that the number of individuals taking anti-coagulants is increasing at the rate of about 5% per year in the US. Latest data indicate that there are an estimated 4.5 million people on anti-coagulants in the country. The most widely prescribed anti-coagulant medication in the U.S. for some time now is warfarin (Coumadin, Jantoven ), although recently newer drugs have come on the market. This increase is partly related to the demographics of an aging population, but also to the their recommended use for more conditions.

Today anticoagulants are prescribed to for:
* Patients who have received mechanical heart valves
* Patients who have afibrillation (Afib) – Irregular heart beat
* Patients over 40
* Obese patients

Many patients on warfarin-type anti-coagulants will need to take them an entire lifetime. These patients require monitoring of their dosage on a regular monthly basis to be certain that their blood will not coagulate too fast or too slowly. This measure of coagulation time is termed prothrombin time/ internationalized normalized ratio (PT/INR) or simply INR.

Risks of Deviation from Anti-Coagulants Therapeutic Dose Range:
* Stroke
* Blood clots in lungs
* Blood clots in deep veins
* Uncontrolled bleeding
* Death

Diet, stress and individual patient variability have been known to affect INR levels.  Most commonly, patients need to go to their physician’s office, laboratory or special coagulation clinics for these INR measures. The blood is drawn, sent for analysis and results are attained in a couple of hours or a few days. The physician then advises the patient if any changes are needed in their anti-coagulant regimen.

Several companies have brought to the market devices that allow patients to check their INR at home and report results to their physicians by phone or online. Home testing allows for more frequent determinations and research has shown that those patients who check weekly remain in the therapeutic range more of the time. In addition, in contrast sampling blood from a vein can sometimes be painful, home testing devices rely upon less traumatic finger stick to produce the needed drop of blood. For patients who are disabled or who rely on others for their travel needs or who need to travel far for monthly testing, home testing is the preferred method. Research has shown that over 75% of patients prefer home testing for its as its convenience and its potential to improve their quality of life.

Home Testing INR Systems

INRatio 2 PT/INR System – Alere. Requires meter to read 15 micro liters of blood on a test-strips.

CoaguChek XS – Roche Labs. Requires meter to read 10 micro liters of blood on a teststrips.

ProTime Microcoagulation System – ITC. Requires meter to read 27 micro liters blood on a cuvette.

In the US, it is reported that 66% of patients are unaware of these home devices and it is estimated that only about 3% actually use them. In Europe, INR self-testing is much more common as is self-management of the anti-coagulant dosage. Advocates for INR home testing argue that INR home testing should be as routine as a diabetics checking their own sugar level.

In the US, insurance coverage for these devices, particularly Medicare, had been delayed for over fifteen years and remains incomplete. Currently Medicare provides reimbursement if warfarin is prescribed for heart valve replacement, but not for other conditions. Private insurers have confusing reimbursement guidelines which often require letter writing and phone calls explaining the necessity for home testing. So although reimbursement may be allowed for supplies which can cost between $7-19 per test, currently physicians or clinics often need to purchase the meters for $1,500-$2,000 and maintain them before loaning them to their patients.

So far, there are no studies that demonstrate reduced morbidity with the use of home coagulation devices. Furthermore, with doubts being raised in the U.S. regarding the financial viability of the new Affordable Care Act and increased discussions about entitlement programs such as Medicare, there are not too many individuals that are betting on additional insurance coverage for such devices anytime soon. On solution has been the development of newer anti-coagulants such as dabigatran (Pradaxa) and rivaroxaban (Xarelto), that do not require regular monitoring. It almost seems that there now needs to be further technical developments that will allow for a cheaper alternative to sophisticated chemical meters. Perhaps with smart phones being so ubiquitous, the chemical reactions on test strips can be converted chromatically and and an App could then translate the colors to INR readings. Until such time, use of these home devices will likely not keep up be with the increased number of patients that will be taking anticoagulants and who require regular INR monitoring.

- Jacob J. Klausner


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Home HIV Testing To Be Legalized in England

Home testing kits for HIV have been available for sale in the US after the Food
and Drug Administration (FDA) gave their approval on July 3, 2012.
Unfortunately, British citizens are still not able to enter their local pharmacy to
purchase such kits, so some have resorted to purchasing them online while
others have relied on their free distribution from gay advocacy groups. Home
tests are entirely self-contained and allow an individual to determine test results
on their own. Less convenient home-sampling HIV kits, requiring that saliva or
blood be sent to a laboratory for further analysis, have been available in England
for some time.
This is all expected to change some time in April of next year. Last month, the
British Department of Health approved for the first time in principle the over-thecounter
sale of HIV home testing kits. Only those kits that receive approval from
the Medicines and Healthcare Regulatory Authority will be allowed on store
shelves. In addition, kits will also need to carry the European Community or CE
mark, indicating they have met specific requirements established by the
Commission European for such test kits. These requirements mostly pertain to
the test’s ability to correctly identify those individuals who actually have HIV
antibodies and those that do not.
Experts have raised several concerns regarding HIV home-testing. First,
although the technology incorporated in such self tests is very similar to the
technology of HIV tests administered in physician offices for many years, for
several reasons, identical tests that are self-administered are less sensitive than
when administered by medical professionals. As a result, individuals using the
home tests may test positive when in actuality they were not exposed to the HIV
virus but few will test negative despite being exposed. Further, if the test is done
within the first 3 months following suspected HIV exposure and before the body
can form antibodies, then the test outcome will be falsely negative at a time when
the individual is most contagious. Additional concerns relate to those who’s home
test is positive but do not follow up with proper medical care and do not receive
adequate emotional support.
Despite these concerns, it has been estimated that up to 20% of individuals in
the US are are not aware of their positive HIV status. This estimate has provided
home-testing advocates with strong arguments in favor of home-test legalization.
Medical authorities in the U.S. and England, advise that any home test results
that are found to be positive, always be followed up and confirmed with more
reliable medical testing in a physician’s office.

-Jacob J. Klausner


Do you know your HIV risk? Try our online assessment quiz.

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Bowel Cancer Home Screening Kits Issued to Oxfordshire Residents

A recent news item in the Oxford Times reports that the British National Health Service sent out free bowel cancer home tests to over 30,000 residents of Oxfordshire. The home test kits are issued every two years to individuals 60-75 in England in the hope that by simplifying the screening process, more cases will be diagnosed early enough to make a significant difference in the treatment process.

As the NHS states on their website, “Bowel cancer can be present for a long time before any symptoms appear. If bowel cancer is detected before symptoms appear, it is easier to treat and there is a better chance of surviving the disease.” Despite this, less than two-thirds of the residents targeted in Oxfordshire have returned samples to be tested. One resident pointed out in an interview that he had ignored the home test at first because it struck him as unpleasant. Only after the NHS reminder came through the mail did he proceed with the home screening and discover he did, in fact, have bowel cancer.

Literature from the NHS reveals that bowel cancer, as the third most common cancer, is the second leading cause of death by cancer. With both men and women at risk and one in 20 people developing bowel cancer in their lifetime, the Fecal Occult Blood Test is one of the best ways to detect the cancer before symptoms are noticed.


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Health PEI Offers Residents Easy Home Tests for Colorectal Cancer

A new initiative by the Canadian Cancer Society aims to make Prince Edward Island residents more aware of colorectal cancer, the third most prevalent cancer on the Canadian island. Treatment for colorectal cancer can be treated effectively; however, the treatment process is often delayed because individuals do not actively pursue regular screening.  Annual screening for colorectal cancer is recommended for people between the ages of 50-74, but as the Canadian Cancer Society rightly pointed out, most people assume colonoscopies are the earliest method of detection, but in fact, home tests, specifically Fecal Occult Blood Tests, provide accurate detection. According to CBC News, screening on PEI nearly doubled over the course of a year, from 2,200 to 4000. It is suspected that home tests, now offered by Health PEI, are in large part responsible for the increase in screenings because of the ease, especially compared to colonoscopies, with which a home test can be administered.

Home stool test kits actually provide screening for wide range of health issues, from polyps and hemorrhoids to Crohn’s Disease and bleeding ulcers. According to the FDA, there are a few methods by which one can collect samples for the Fecal Occult Blood test and the results can be either be sent to a lab or tested at home. If the directions are strictly followed, the results of the home test are as accurate as those of a lab.

For more information on PEI and the Canadian Cancer Society, read this article by CBC news.

For more information on the Food and Drug Administrations Fecal Occult Blood test recommendations, click here.

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