Friday, November 29, 2013

The FDA Set Back Science One Hundred Years Barron’s Medical Suggest Start With Breast Cancer 23 And Me

Barron’s Medical Journal Reporting From Harvard University Boston, MA USA

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.

Thursday, November 14, 2013

Is Amy Robach Making The Right Breast Cancer Treatment Choice At 40


Barron's Medical Journal Reporting From Duke University Medical School Durham, NC USA (Global Newswire )(AP News)

Is Amy Robach Making The Right Breast Cancer Treatment Choice At 40


Durham, NC (AP) After Good Morning America’s Amy Robach was diagnosed with Breast Cancer Barron’s Medical Journal Asked The CEO Of Sam Houston Biotech Inc Rose Conrad what she taught of the announcement ? Rose was happy to see that so many Women will now take notice and be willing to take a test at forty years of age to see if they are candidates for breast cancer. Conrad went on to say, why did Good Morning America not include A Genomic Test as part of the breast cancer testing process.

Genomics is a discipline in genetics that applies recombinant DNA, DNA sequencing methods, and bioinformatics to sequence, assemble, and analyze the function and structure of genomes (the complete set of DNA within a single cell of an organism). We then ask Rose is her company Doing any work with Genomics for breast cancer and if so explain the process. Genomics is the Gaussian processes in action, to predict the likelihood of chemotherapy benefit as well as recurrence, for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive. Additionally, physicians use Sam Houston to make treatment recommendations for certain node-positive breast cancer patients, and the test report also provides quantitative scores for select individual genes. Sam Houston has been extensively evaluated in thirteen clinical studies involving more than 4,000 breast cancer patients worldwide, including a large validation study published in The New England Journal of Medicine and a chemotherapy benefit study published in the Journal of Clinical Oncology. Both Medicare and private health plans covering over 90 percent of U.S. insured lives provided reimbursement for Sam Houston for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive through contracts, agreements or policy decisions.

Breast Cancer Researchers and Scientist are ahead of the curve with several new technologies based on Nanoparticles and Semi Conductors Namely Genomics and treatments. The field of genomics is caught in a data deluge. Targeted breast cancer DNA sequencing is becoming faster and cheaper at a pace far outstripping Moore’s law, which describes the rate at which computing gets faster and cheaper.

The result is that the ability to determine Targeted breast cancer DNA sequences is starting to outrun the ability of researchers to store, transmit and especially to analyze the data.

The cost of sequencing a human genome — all three billion bases of DNA in a set of human chromosomes — plunged to $10,000.00 which means genomics breast cancer DNA sequencing is around $3000.00.

The lower cost, along with increasing speed, has led to a huge increase in how much breast Cancer sequencing data is being produced.

Numerous investigations have shown that both tissue and cell distribution profiles of anticancer drugs can be controlled by their entrapment in submicronic colloidal systems (nanoparticles). The rationale behind this approach is to increase antitumor efficacy, while reducing systemic side-effects. This review provides an update of tumor targeting with conventional or long-circulating nanoparticles. The in vivo fate of these systems, after intravascular or tumoral administration, is discussed, as well as the mechanism involved in tumor regression. Nanoparticles are also of benefit for the selective delivery of oligonucleotides to tumor cells. Moreover, certain types of nanoparticles showed some interesting capacity to reverse MDR resistance, which is a major problem in chemotherapy. The first experiments, aiming to decorate nanoparticles with molecular ligand for active targeting of cancerous cells

Miniaturization will allow the tools for many different tests to be situated together on the same small device. Hybrid Sam Houston Researchers Say that nanotechnology will allow them to run many diagnostic tests simultaneously.

Nanoparticles nanoshells is use to antibodies that recognize cancer cells. Sam Houston scientist envision letting these nanoshells seek out their cancerous targets, then applying near-infrared light. The heat generated by the light-absorbing nanoshells can successfully killed breast cancer tumor cells while leaving neighboring cells intact.

A nanometer is a billionth of a meter. It's difficult to imagine anything so small, but think of something only 1/80,000 the width of a human hair. Ten hydrogen atoms could be laid side-by-side in a single nanometer.

Sam Houston minuscule molecule that will be used to detect breast cancer is a quantum dot. Quantum dots are tiny crystals that glow when they are stimulated by ultraviolet light. The wavelength, or color, of the light depends on the size of the crystal. Latex beads filled with these crystals can be designed to bind to specific DNA sequences. Hybrid Sam Houston understands that Hyperthermia gold nanoshell Targeted breast cancer genomics at 40 for high risk women will reduce breast cancer at 60 years of Age. Training Genomics Counselor and Storing DNA Analysis in the cloud will allow Hybrid Sam Houston to say that Chemotherapy will help their breast cancer outcome or if Chemotheraphy and Hyperthermia will extend their life.

The impact of genomics and pharmacogenomics in the current arena of clinical oncology is well-established. In breast cancer, mutations in the BRCA1 and BRCA2 genes have been well-characterized to carry a high risk of the disease during a woman's lifespan. However, these high risk genes contribute to only a small proportion of the familial cases of breast cancer. Hence, further efforts aimed to study the contribution of genetic mutations in other genes, including the estrogen receptor gene, TP53, CYP19, and mismatch repair genes to further investigate the genetic component of breast cancer.

Multiple pharmacogenomic studies have previously linked genetic variants in known pathways with treatment response in cancer patients. Currently, polymorphisms in drug metabolizing enzymes, efflux transporters, as well as, drug targets have shown correlations to variations in response and toxicity to commonly prescribed chemotherapeutic treatments of breast cancer. CYP2D6 variants have been correlated with tamoxifen response and interindividual variability seen. An emerging application of cancer genetics and pharmacogenetics involves the use of inherited or acquired genetic abnormalities to predict treatment toxicity or outcomes. Recently, methods that involve the scanning of entire genomes for common variants have begun to influence studies of cancer causation. Currently, treatment individualization for breast cancer can take place on the basis of few molecular targets including the estrogen receptor and the overexpression of the HER2 receptor. Overall, the current review summarizes the recent findings in the genetic and pharmacogenetic research of breast cancer and the advances made in personalization of treatment.

Women that use a Genomic Breast Cancer Test at 40 has a eighty seven percent chance to make sixty

Tuesday, November 5, 2013

Want To Know The Power Of Breast Cancer Research Funding Perjeta


Want To Know The Power Of Breast Cancer Research Funding Perjeta

Barron’s Medical Journal Reporting from The University Of Texas Medical School Houston, Texas USA


Houston ( AP ) Barron’s Medical Journal is at The University of Texas Medical School to bring you the latest in breast cancer research. Yes there is a new kid on the block for breast cancer Perjeta. Perjeta was only used for Women that had stage four breast cancer and now thanks to millions of dollars spent on breast cancer research the FDA has approved Perjeta to be use in Stage one breast cancer. This is fantastic news and the power of genomics science what use to take years now companies like Roche and other are using genomic to speed up their research.

United States (U.S.) Food and Drug Administration (FDA) granted accelerated approval of a Perjeta (pertuzumab) regimen for neoadjuvant treatment (use before surgery) in people with high-risk, HER2-positive early stage breast cancer. This approval is based primarily on data from a Phase II study showing that nearly 40 percent of people receiving the combination of Perjeta, Herceptin (trastuzumab) and docetaxel chemotherapy had no evidence of tumour tissue detectable at the time of surgery (known as a pathological complete response, or pCR). The Perjeta regimen is the first neoadjuvant breast cancer treatment approved by the FDA and also the first to be approved based on pCR data.

The approval of pertuzumab for neoadjuvant treatment of breast cancer is based on a randomized, multicenter, open-label trial in patients with HER2-positive, operable, locally advanced or inflammatory breast cancer

Brought To You By Singer & Song Writer Kristen Mills (T2-4d). Breast tumor samples were required to show HER2 overexpression (IHC 3+ or FISH amplification ratio of at least 2.0 determined by a central laboratory). The trial enrolled 417 patients who were randomly assigned to receive 1 of 4 neoadjuvant regimens prior to surgery as follows: trastuzumab plus docetaxel; pertuzumab plus trastuzumab and docetaxel; pertuzumab plus trastuzumab; or pertuzumab plus docetaxel.

Pertuzumab, trastuzumab, and docetaxel were administered preoperatively by intravenous infusion (IV) every 3 weeks for a total of 4 cycles. Following surgery all patients received 3 cycles of fluorouracil, epirubicin, and cyclophosphamide (FEC) IV every 3 weeks and trastuzumab was administered IV every 3 weeks to complete 1 year of therapy. The trial’s primary endpoint was pathologic complete response (pCR) rate defined as the absence of invasive cancer in the breast (ypT0/is). The FDA-preferred definition of pCR is the absence of invasive cancer in the breast and lymph nodes (ypT0/is ypN0). PERJETA is a sterile, clear to slightly opalescent, colorless to pale brown liquid for intravenous infusion. Each single use vial contains 420 mg of pertuzumab at a concentration of 30 mg/mL in 20 mM L-histidine acetate (pH 6.0), 120 mM sucrose and 0.02% polysorbate 20.

Some breast cancers have large amounts of a protein called HER2 on the surface of the cells. These cancers are ‘HER2 positive’ and can be treated with a drug called trastuzumab which targets the HER2 protein. You may have trastuzumab with chemotherapy. Paclitaxel anddocetaxel are drugs that doctors often use.

Sam Houston Biotech A Houston Based cancer Research Organization has found that genomic science has advanced. Sections of microarray provide targets for parallel in situ detection of DNA, RNA and protein targets in each specimen on the array. The better News is that Genomics is on the Clock. Genomics provide a faster cheaper more effective way to detect the Her2 gene by using Semiconductor Sequencing. A example of this technique is Gennxeix Biotech Inc Semiconductor Sequencing. "Quantum Theory" In Action for Breast Cancer Patients. One of the major player and touch down makers for breast cancer is Houston Texas Methodist Hospital. In A clinical Trial A Rev. Noel Denison, a retired Methodist minister, was diagnosed with locally advanced HER2-positive breast cancer and is enrolled in the study at Methodist, one of only two locations in the United States. The clinical trial is for locally advanced or metastatic HER2-positive breast cancer and combines standard chemotherapy with trastuzumab emtansine, better known in the breast cancer world as T-DM1, and pertuzumab, a monoclonal antibody that also attaches to HER2 on cancer cells. Using Genomics and semiconductors to detect breast cancer plus T-DM1 to treat breast cancer is a winning combination. What is T-DM1? T-DM1 is in a new class of cancer-fighting agents called antibody drug conjugates. By combining the antibody trastuzumab directly with docetaxel (standard chemotherapy) and/or pertuzumab, the T-DMI is designed to attack the tumor cells directly and deliver the chemotherapy. Trastuzumab emtansine (T-DM1) consists of our proprietary DM1 cancer-killing agent attached to the HER2-binding antibody, trastuzumab, developed by Genentech (a member of the Roche Group) using our linker and methods of attachment. Trastuzumab emtansine is in global development by Roche under a collaboration agreement between ImmunoGen and Genentech. Marketing applications for trastuzumab emtansine are under review in the US and Europe. The Defense and the most dangerous aspect of breast cancer is its ability to spread to distant sites, most tumors are initially unable to do that Learning more specifically what triggers metastases may provide additional targets for preventing and treating the malignant process that causes cancer deaths.

It’s widely accepted that cancers acquire the ability to spread through the gradual accumulation of genetic changes, and experiments have also shown that these changes occur in parallel with changes in the protein content and 3-dimensional patterning of the protein meshwork that creates their immediate surroundings Gene that stops the growth of KCNK9 Genes is gene is p53. p53 is a fundamental determinant of cancer susceptibility, p53 integrates stress signals and elicits apoplectic responses that maintain genomic stability. When cells sense a decrease in oxygen availability (hypoxia), they develop adaptive responses in order to sustain this condition and survive. If hypoxia lasts too long or is too severe, the cells eventually die. Hypoxia is also known to modulate the p53 pathway, in a manner dependent or not of HIF-1 (hypoxia-inducible factor-1), the main transcription factor activated by hypoxia. The p53 protein is a transcription factor, which is rapidly stabilized by cellular stresses and which has a major role in the cell responses to these stresses. This process is why it is important Conrad says for people that are first degree relatives of breast cancer patients, must take a genomic test to see if they are the carrier of gene KCNK9. By identifying this gene we can direct patients with the correct advise as to deal with the fact that they have a lunp on the breast to they are going to get a lump on their breast. Often what happens is that a breast cancer patients dose not go to the doctor or take important test to see if there is a lump on the breast. what happens is the spread of breast cancer is responsible for more than 90 percent of breast cancer deaths.

Pertuzumab is a type of biological therapy called a monoclonal antibody. It works by targeting the HER2 protein but in a different way to trastuzumab. We know from research that having both pertuzumab and trastuzumab together may be better than having just one of them alone.

TDM1 is a combination of trastuzumab and a chemotherapy drug called DM1. Trastuzumab finds the cancer cells and delivers the DM1 to them. This type of drug is called a conjugated monoclonal antibody.

It is clear to Barron’s Medical Journal first year oncologist will have a new way of treating breast cancer all before the end of President Obama second Term