The FDA Set Back Science One Hundred Years Barron’s Medical Suggest Start With Breast Cancer 23 And Me
Boston MA ( AP )The most dangerous thing the Federal Drug Administration has done in the last one hundred and fifty Years. Was to step in to the greatest thing to happen to science in one hundred years. Says Rose Conrad The CEO of Sam Houston Medical Software a Houston, Texas Base Company that specialized in Genomics Science. Conrad says the entire science community in the United States was elated when Google the Internet Search Company invested in a company called 23 and Me. For Ninety Nine dollars you can get a entire Genetic test for ninety nine dollars. Out of the blue was sent a 
letter by the FDA to stop selling the test. Anne Wojcicki, co-founder of $99 DNA testing service 23andMe, countered a warning letter issued by the Food and Drug Administration demanding the company "immediately discontinue marketing" its DNA testing kit.
"We stand behind the data that we return to customers—but we recognize that the FDA needs to be convinced of the quality of our data as well," Wojcicki said in a blog post on the company's website Tuesday night.a
On Nov. 22 the FDA ordered 23andMe to halt marketing of its genetic testing device, expressing concern that it could return inaccurate results and lead consumers to undergo unnecessary health procedures.
Did you know that we have a breast cancer treatment model that has not changed in many Physicians offices since 1970? In 1970 A MCF-7 is a breast cancer cell line isolated in 1970 from a 69-year-old Caucasian woman. MCF-7 is the acronym of Michigan Cancer Foundation - 7, referring to the institute in Detroit where the cell line was established in 1973 by Herbert Soule and co-workers The Michigan Cancer Foundation is now known as the Barbara Ann Karmanos Cancer Institute.
This is why we now have analytics that says that fifty percent of the Women in the United States that get chemotherapy do not need it. This is why that so many reports says that Black women get breast cancer and a rate of 18% and White women a rate of 7% . Prior to MCF-7, it was not possible for cancer researchers to obtain a mammary cell line that was capable of living
longer than a few months, since the 1950’s when this car was created a big change in the way we treat breast cancer patients in 1970… Now In 2012 we are making another major change. The Change is a Medical Technology Called Genomics. The patient, whose name, Frances Mallon, is unknown to the vast majority of cancer researchers, died in 1970. Her cells were the source of much of current knowledge about breast cancer Scientist around world is working with genomics. For an example, The International Cancer Genome Consortium (ICGC) today announced four new projects in China to identify the genomic drivers in colorectal, esophageal, liver and nasopharyngeal cancers, helping lay the foundation for developing treatments tailored to patients’ individual needs. China is a founding member of the ICGC, having launched a gastric cancer project in 2008.
The Consortium leads worldwide efforts to map the genomes of both common and rare cancers and has the goal of identifying cancer-causing mutations in more than 25,000 tumors representing more than 50 types of cancer of clinical and societal importance across the globe. Houston base companies like Sam Houston Biotech found involvement in human breast cancer progression, based on the analysis of human breast cancer biopsies and experimental animal mice models. HIF-1 as a therapeutic target can extend the life of many stage four breast Cancer patients.
Sam Houston discovered The tumor suppressors VHL (von Hippel-Lindau protein) and p53 target HIF-1α for ubiquitination to inactivation breast cancer tumors cells increases the of HIF-1. This process Increased phosphatidylinositol 3-kinase (PI3K) and AKT. In breast cancer, increased activity of the HER2 (also known as neu) receptor tyrosine kinase is associated with increased tumor grade, chemotherapy resistance, and decreased patient survival. HER2 has also been implicated 
as an inducer of VEGF expression. Sam Houston demonstrate that HER2 signaling induced by overexpression in mouse 3T3 cells or human MCF-7 breast cancer cells results in increased HIF-1α protein and VEGF mRNA expression that is dependent upon activity of PI3K, AKT (also known as protein kinase B), and the downstream kinase FRAP (FKBP-rapamycin-associated protein)
Sam Houston concern with patients with diabetes and breast cancer may not receive full Benefit of HIF-1. All women having access to a physician can have access to HIF-1.
Genomics provide a faster cheaper more effective way to detecting Breast Cancer by using Semiconductor Sequencing.
A example of this technique is Sam Houston Semiconductor Sequencing.
"Quantum Theory" In Action for Breast Cancer Patients.
A polymerase is an enzyme whose central function is associated with polymers of nucleic acids such as RNA and DNA. The primary function of a polymerase is the polymerization of new DNA or RNA against an existing DNA or RNA template in the processes of replication and transcription. In association with a Sam Houston also uses a Visualize Real-Time Breast Cancer Data using Signal Stochastic Resonance Units Neurons Detection
and Analysis for Breast Cancer model after McCulloch-Pitts.
Gennxeix. computer-assisted diagnosing of breast cancer from mammograms. Sam Houston works is a genetic network simulation trained with tumor incidence data from knockout experiments.
Sam Houston uses Semiconductor Sequencing Chips that create a direct connection between Biochemical and digital information, bringing these two languages together. Gennxeix's chips are designed like any other semiconductor chips.
Pairing proprietary semiconductor technology with sequencing
chemistry a nucleotide is incorporated into a strand of DNA by a polymerase, a hydrogen ion is released.
Sam Houston used a high-density array of micro-machined wells for bioctechnology process in a massive way. Each well holds a different DNA template. Beneath the wells is an ion-sensitive layer and beneath that a proprietary Ion sensor.
Genomics can be the GPS to Extend life in Breast Cancer Patients.
Barron's Medical Journal reported that hope for young women, those under 35, who get breast cancer out of the blue – especially because they are far more likely than older women to have a hard-to-treat type of breast cancer called triple negative breast cancer. A chemotherapy treatment called neoadjuvant chemotherapy can actual reduce the size of large triple negative breast cancer tumors. The efficacy of neoadjuvant chemotherapy, as measured by the rate of pathological complete response (the absence of invasive and intraductal disease in the breast and the axillary lymph nodes), varies according to breast-cancer subtype.
When anthracyclines, taxanes, and agents directed against anti–human. First degree relatives of Breast Cancer Patients that take a Genomic test and find that the genes P53, P63, Her-2 and more are the largest candidates neoadjuvant chemotherapy treatments. A Houston base company called Sam Houston researcher work product. lets discuss some of their finding. Sam Houston discovered that some patients with HER2-positive breast cancer tended not respond to HER2-targeted therapies. Also, some patients with triple-negative breast cancers responded to therapies while others didn't. "We have been lumping things together that shouldn't be lumped together The new classifications - four types called HER2 "enriched," luminal A, luminal B and basal-like - categorize breast cancers by their genomic structure using a dizzying array of data points not previously available that have identified new pathways for the cancer to do its damage, making it possible for researchers to identify new places to target disease.
Anne Wojcicki, named "Most Daring CEO" by "Fast Company" magazine. Her start-up, 23andMe, lets consumers learn about their medical future with a $99 DNA test.
Wojcicki said her company has worked extensively with lab partners to ensure that all testing results are accurate, but she acknowledged that the company was "behind schedule" in responding to the FDA's request for more information, which resulted in the product's lack of marketing clearance. "This is new territory for both for 23andMe and the FDA," Wojcicki said. "This makes the regulatory process with the FDA important because the work we are doing with the agency will help lay the groundwork for what other companies in this new industry do in the future." Wojcicki, who recently separated from Google co-founder Sergey Brin, co-founded 23andMe in 2006. Google is an investor in the company. The FDA gave the company 15 working days to respond to its letter and outline the steps it is taking to address the agency's concerns. Recently, the Food and Drug Administration sent a letter to 23andMe telling the company to stop marketing its DNA testing kits, because the kits require FDA approval, which the company had not obtained. The letter emphasizes the need for 23andMe to prove that their tests are accurate. "FDA is concerned about the public health consequences of inaccurate results from the [Personal Genome Service] device; the main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work," the letter reads, referring to 23andMe's genetic testing product.
However, according to one expert, the accuracy of the test is not the biggest issue. The company's testing methods have been found to meet federal standards for lab testing, called Clinical Laboratory Improvement Amendments (CLIA), said Amy Sturm, a genetic counselor at The Ohio State University Wexner Medical Center.
A greater problem is that the results provide "a very incomplete view" of a person's risk for a given disease, Sturm said. Limited view.
The company says that its DNA testing kit and analysis — which have been sold in the United States for more than five years, according to the FDA — can tell people whether their genes indicate an increased risk for more than 250 diseases and conditions.
To do so, the test identifies certain genetic markers, or single nucleotide polymorphisms (SNPs), which are single spots in the DNA that vary among people and have been linked in research studies to diseases. 
But for many of these diseases, the company tests just a few genetic markers, when in reality, many other factors, including additional genetic markers, likely contribute to the development of the diseases, Sturm said.
For example, to assess breast cancer risk, the test relies on three SNPs within the breast cancer genes BRCA1 and BRCA2, and eight other markers (SNPs) linked with breast cancer.
"The fact of the matter is … that's just such a limited view of breast cancer genetics," Sturm said. Researchers suspect that hundreds, if not thousands, of genetic markers likely influence breast cancer risk. And so even if people do not have those three SNPs, they could still have a genetic mutation that puts them at risk for breast cancer. The company also does not obtain a family history, or take into account environmentalfactors that may contribute to disease risk. [6 Foods That May Affect Breast Cancer Risk.
For instance, 23andMe provides a report on a person's risk of type 2 diabetes, but genetics contributes to just 26 percent of a person's risk, according to the company. The rest is due to environmental factors, such as obesity, physical inactivity and a history of heart disease, 23andMe said. And there are still unknown genetic factors that the test cannot take into account "It's just a very small snapshot of anyone's particular risk," said Barbara Bernhardt, a genetic counselor and professor of medicine at the University of Pennsylvania School of Medicine.
While 23andMe does explain that its tests do not take into account all of the factors that contribute to disease risk, that won't necessarily stop people from getting the wrong idea, Sturm said.
For example, a few years ago, Sturm counseled a man who had questions about his 23andMe results. The man was very concerned about his risk of esophageal cancer, based on his results. But after taking the man's family history, Sturm found out the man should be more worried about heart disease, which ran in his family, than esophageal cancer, Sturm said. And the increased risk of esophageal cancer discussed in the 23andMe report was based on a single genetic marker that had been studied only in a Chinese population, Sturm said. (The man was not Chinese, so it was unclear if the results applied to him, Sturm said.)
This counseling experience highlights another major issue with direct-to-consumer genetic tests: Consumers can take them without going through their health-care providers, experts say. "The danger is just, most people do not have the educational background to fully understand [the tests] themselves, what the result means," Sturm said.
Bernhardt agreed. "Since the beginning, the main concern has been about the potential for misunderstanding of the results, and the lack of resources that may be available to people to help sort out results," she said.
If people's results show they are at average risk for a disease, they might be overly reassured by the finding; and if the results show they are at increased risk, they may seek medical tests that they do not need, Sturm said. For instance, the man Sturm counseled kept asking if he needed a screening test for esophageal cancer, when he did not need one.
However, 23andMe does advise consumers to speak with their doctors if they have concerns about their results, and also offers to connect people with genetic counselors to explain results. But it's unclear how many people take advantage of these services, Sturm said.
In addition, people who take a genetic test through their doctors would likely undergo pre-test counseling to discuss what the results might reveal, and whether the patient would be ready to deal with such results. People who take the 23andMe test don't need to undergo pre-test counseling, even though the results might show a genetic risk for conditions such as Alzheimer's disease.
We have to move the Ball forward FDA stop this Maddnes.
