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The Value of Molecular Diagnostics

To better understand the technology that BreastDefense is using, a report byAdvaMedDxgives is a very good overview of the molecular diagnostic field.

“The introduction and expanding use of molecular diagnostic tests to detect cancer and manage cancer care mark a major milestone and herald future progress in the fight against this disease – begins the report by AdvaMedDx a trade association that leads the effort to advance medical technology.

Advances in diagnostics technologies and in our fundamental understanding of the mechanisms of cancer at a molecular level are driving the development of new treatments and diagnostic tests.

Molecular diagnostics can assess a person’s risk of developing a disease, determine whether a person is a carrier of a hereditary condition, screen for diseases that are present but not yet symptomatic, provide a diagnosis of existing symptoms, or monitor how a patient is responding to treatments.

The brief report is intended to concisely summarize the complex science underlying the use of molecular diagnostics, particularly genetic tests, and their application in cancer screening, diagnosis, prognosis, treatment selection, and monitoring.

The specific and actionable insights that molecular diagnostics provide at every stage of care make them one of the most dynamic and transformative areas of diagnostics health care. “

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Breast Biopsies – are not always accurate

The video The Pathology of Errors is about the consequences of a inaccurate image reading. Since treatment is based on the diagnosis of the pathologists report, it is critical that the diagnosis is correct. It is now recommended that women seek second opinions when given a diagnosis of breast cancer. This video is a good overview of what can happen.

When a suspicious lump is found on a mammogram, women are sent for a tissue biopsy. But sometimes the pathologist has difficulty determining if cancer is present. As with mammography, the images under the microscope can be inconclusive. In these instances many pathologists will get a second opinion from another pathologist.

BreastDefense does not rely on images.  By measuring these suspicious tissues at the molecular level, BreastDefense will be able to answer the question is it cancer or is it benign from stage 1 thru 4 with 99% accuracy, for both false positives and false negatives. It can give the pathologist a clear answer, cancer or no cancer.

Here is an abstract on a study done in 2015 to quantify the magnitude of diagnostic disagreement among pathologists.

Diagnostic Concordance Among Pathologists Interpreting Breast Biopsy Specimens

The actual error rate for pathologists is unknown.  The time has certainly come for more studies in this area.

 

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40 over 40

40% of Women Over 40 Have Dense Breasts.

Why does this matter?

Fact
the denser the breast the higher the risk of getting breast cancer.

Fact
having dense breasts is a greater risk factor than having a family history of breast cancer.

Fact
mammograms miss about 50% of breast cancer in the densest breasts.

The above Facts come from the website dense breasts canada  Watch their video- it is very powerful.

EARLY DETECTION MATTERS

Dense breasts are normal and common. 40% of women over the age 40 have dense breasts.

Dense breasts make it harder for radiologists viewing your mammogram to spot cancer because dense breast tissue shows up as white and so does a cancerous tumour.

Ask your doctor if you have dense breasts.

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Young Women with Breast Cancer – The Forgotten Generation?

Are young women a forgotten generation when it comes to breast cancer?  Thousands of young women are diagnosed every year. They often face the most aggressive cancers.

One young Canadian women, profiled in Rachel Ray Everyday shared her story.  Judit Saunders was 26 years old and working as a registered nurse at a major children’s hospital in Calgary when she discovered a lump. She was diagnosed with hormonally driven HER2 positive breast cancer. She went through all the standard care treatments. Two and a half years later , it came back as stage four breast cancer. Now, she is in treatment for life, but she hasn’t let the disease stop her from living.

BreastDefense could make the ongoing monitoring of cancer easier.

When cancer is diagnosed in a young person it is a very different experience than when diagnosed mid to late life. “In the young adult years, you’re really laying the foundation for the rest of your life. Finishing school, starting careers, starting a family” says Geoff Eaton, Young Adult Cancer Canada (YACC) executive director and two time cancer survivor.

Young Adult Cancer Canada has teamed up with Memorial University to conduct a study that hopes to shed more light on the challenges of young adults with cancer.  “we’re spending more money on people who are kind of past the majority of their life and ignoring the people who have most of their life still to live” says MUN’s Dr. Shelia Garland. The Prime Study – named since it is examining people who are diagnosed with cancer in the prime of their lives – has seen 500 young adult cancer survivors weigh in with their own experiences.. The aim is to explore the physical, social and emotional challenges facing young adults with cancer.

The majority of breast cancers – 51% , are women between the ages of 50 and 69. But there are still many many women under the age of 40 – (over a 1000 new cases a year in Canada),  that get the news from their doctor that they have breast cancer.

BreastDefense is a simple test that could benefit breast cancer survivors in monitoring remission.

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From Bench to Bedside – BreastDefense and Translational Medicine

Translational research is generally considered a process that starts in the lab—the “bench”—where a new drug, device, or procedure is developed, and ends with the production that makes it available in the clinic—the “bedside.”

Barry S. Coller from the Rockefeller University, NY defines translational medicine as: “The application of the scientific method to address a health need.”

He holds that, in contrast to basic research, which has the generation of new knowledge as its primary goal, the primary goal of translational science is improvement in human health.

BreastDefense is very close to the “bedside”. The BreastDefense tissue test could be made available to women within a year and the blood test just 24 months later.

“We know more about the human body today than we did yesterday, and tomorrow we’ll know even more—a lot more. In the last two decades, advances in human genome sequencing, molecular imaging, and other areas have sparked a research revolution that reveals ever more detailed and precise information about how our bodies work. Every day brings new discoveries, many of which may hold the potential to improve human health in meaningful ways.

But the pace at which those discov­eries lead to improved health has been frustratingly slow. Yes, new drugs and new therapies do reach patients, and when they do, they often make a tre­mendous difference. But relative to the number of research projects conducted, papers published, and trials run, it is clear that new health care advances have lagged behind the vast amounts of data generated by the explosion in biomedical discovery.

If you look at drug development, the failure rate is over 95 percent,” he says. “So an enormous amount of money is being spent nationwide on things that don’t work.”

This except was taken from Duke Medical Alumni News.

BreastDefense is a simple test that we are confident will work and will quickly have a huge impact on breast cancer survivor rates.

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Many Women Could Be Spared Chemotherapy

 

The largest precision medicine study ever done was presented at a plenary session at the annual meeting of the American Society of Clinical Oncology in Chicago. Researchers looked at more than 10,000 women aged 18-75.

Researchers were looking at  whether the standard of care of chemotherapy and endocrine therapy benefit all women with the HER-2  breast cancer.

The test assigned women to a score of 0-100 based on the likelihood that cancer would return within 10 years. The study’s aim was to assess the majority of women in the middle range of 11-25 to see if there was a benefit from chemotherapy.

The results concluded that, depending on a patients age, women who received only endocrine therapy did not fare worse than those who were also treated with chemotherapy.

“practically speaking, this means that thousands of women will be able to avoid chemotherapy with all its side effects, while still achieving excellent long term outcomes” said Dr. Harold Burstein, an associate professor at Harvard Medical School.

The abstract from the New England Journal of Medicine can be found here.

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What do Dogs and BreastDefense have in Common?

Some biologists think that a target of 99% accuracy for any cancer screen is unattainable.

It seems that SignPost is not alone in this pursuit.

According to a company called BioScent Dx, dogs are able to smell minute changes in a human bio-markers including hormones, proteins and other organic compounds. This has lead to dogs being trained to aid in the monitoring of conditions such as diabetes, narcolepsy and cancer. BioScent Dx is working on developing a cancer screen for recurrent breast cancer.

Studies have shown that, when trained, dogs can detect cancer from human breath, fecal, and urine samples with up to 99% accuracy.

BreastDefense has determined through initial work that 99% accuracy of breast cancer is attainable.

 

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The Sharks and The Minnows

The wide net of cancer detection is picking up the Sharks – the aggressive tumors – and the Minnows- the non-aggressive tumors.

“We are not seeing enough of the really lethal cancers, and we’re finding too many of the slow moving ones that probably don’t need to be found” says Laura Esserman, a breast cancer surgeon at the University of California, San Francisco.

Early detection has long been seen as a powerful weapon in the battle against breast cancer. Some experts now see it as a double edged sword.

BreastDefense will be able to solve this problem. BreastDefense will be able to distinguish the Sharks from the Minnows.

The entire article can be found here.

This article was written in 2014. There is still no test to tell the difference between invasive and benign breast cancer. However in the past couple of years big data and biology have intersected to create novel methods of research. The technology is advancing rapidly.