martes, 24 de abril de 2018

FoundationFocus CDxBRCA LOH - P160018/S001

FoundationFocus CDxBRCA LOH - P160018/S001

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: FoundationFocus™ CDx BRCA LOH 
PMA Applicant: Foundation Medicine, Inc.
Address: 150 2nd Street 1st Floor, Cambridge, MA 02141
Approval Date: April 6, 2018
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160018S001a.pdf
What is it? FoundationFocus™ CDx BRCA LOH was originally approved as a companion diagnostic designed to detect the presence of mutations in the BRCA1 and BRCA2 genes. The laboratory test can also be used to detect the percentage of genomic loss of heterozygosity (LOH) in tumor tissue samples from patients with ovarian cancer. BRCA1 and BRCA2 stand for Breast Cancer, early onset genes 1 and 2, which are also associated with ovarian cancer. LOH is a genetic event that occurs in many cancer types, and results in the loss of one allele (or copy) of a genetic locus. Patients with BRCA mutations or a high percentage of LOH are classified as positive for homologous recombination deficiency (HRD), which means cells are less able to repair harmful breaks on both strands of DNA. If BRCA mutations are detected or patients have positive HRD status, the patients may be considered for treatment with Rubraca (rucaparib).
Rubraca (rucaparib) is a treatment for patients who have been previously treated for ovarian cancer who have BRCA mutations or positive HRD status, as detected by the FoundationFocus™ CDx BRCA LOH. Rubraca (rucaparib) blocks proteins involved in important cell functions, such as repair of damaged DNA.
How does it work?
  • The doctor orders the test. A tissue sample from the tumor of a patient with ovarian cancer is taken by the doctor, and the sample is sent to Foundation Medicine, Inc. in Cambridge, MA.
  • At Foundation Medicine, Inc., the patient's DNA is isolated from the tumor tissue sample, and then mixed with reagents that specifically detect and analyze the DNA sequences. The patient's sequenced DNA is then analyzed to evaluate the presence or absence of BRCA mutations, the percentage of LOH, and the HRD status.
  • A trained medical professional reviews the results, and then sends a report to the ordering doctor.
  • The presence of BRCA mutations or positive HRD status will be used to help inform treatment decisions with Rubraca™ (rucaparib).
When is it used? FoundationFocus™ CDx BRCA LOH is used to determine if patients previously treated for ovarian cancer may benefit from treatment with Rubraca™ (rucaparib). 

What will it accomplish? FoundationFocus™ CDx BRCA LOH helps to inform treatment decisions with Rubraca™ (rucaparib).
When should it not be used? There are no known contraindications.
Additional information (including warnings, precautions, and adverse events):

Recent Device Approval: FoundationFocus CDxBRCA LOH



FDA has recently approved the FoundationFocus™ CDx BRCA LOHThis was originally approved as a companion diagnostic designed to detect the presence of mutations in the BRCA1 and BRCA2 genes. The laboratory test can also be used to detect the percentage of genomic loss of heterozygosity (LOH) in tumor tissue samples from patients with ovarian cancer. BRCA1 and BRCA2 stand for Breast Cancer, early onset genes 1 and 2, which are also associated with ovarian cancer. LOH is a genetic event that occurs in many cancer types, and results in the loss of one allele (or copy) of a genetic locus. Patients with BRCA mutations or a high percentage of LOH are classified as positive for homologous recombination deficiency (HRD), which means cells are less able to repair harmful breaks on both strands of DNA. If BRCA mutations are detected or patients have positive HRD status, the patients may be considered for treatment with Rubraca (rucaparib).

An Introduction to Tai Chi - Harvard Health

An Introduction to Tai Chi - Harvard Health



Harvard Health Publishing

Discover the Healing Power of Tai Chi — The Ancient Secret to a Healthier, Happier Life

Boost your balance ... Ease your pain ... Reduce your stress ... Strengthen your heart ... and more!

An Introduction to Tai Chi
Your Special Health Report includes:
Basic techniques for better breathing
Proper posture the tai chi way
More than 125 detailed, how-to photos
3 routines to relax and help you revitalize
Helpful links to online videos
Tai chi’s 8 active ingredients of healing
And more!

Read More
Dear CERASALE,
Ever wonder what tai chi is all about? For thousands of years, this ancient Chinese practice has proven to be one of the most powerful ways to improve both your physical and mental health.
The key to tai chi’s scientifically backed health benefits is qi. Rooted in ancient Asian traditions, qi is your vital energy. When your qi freely flows, you are balanced and healthy. But, if your qi is weakened or blocked, you can experience physical, mental, and emotional problems. Tai chi promotes the flow of your qi.
Although tai chi sounds mysterious, research is proving it works!
Start healing from head to toe!
In an increasing number of recent studies, tai chi has been found to lower blood pressure ... reduce stress ... build strength and balance ... slow the onset of dementia ... relieve pain ... and the list just goes on and on. And, better yet, everyone can benefit — no matter your age or fitness level. No wonder it’s the tried-and-true practice of top athletes, active adults, and even people in their 70s and 80s who want to get — or stay — in shape!
Now, in a Special Health Report from Harvard Medical School, our experts show you how to restore your body and mind through this gentle mind-body exercise — for a longer, healthier life — without the risk of injury.
Send for this new report now and discover how to:
  • Lower your risk of falling — by as much as 43% ... and your risk of injury by half!
  • Lift your mood — In 82% of studies, tai chi greatly improved mood and lowered anxiety. Plus, it’s effective for treating depression drug-free.
  • Prevent heart disease — It strengthens your heart five different ways!
  • Say goodbye to pain — A growing number of clinical trials show that tai chi offers significant relief from back, neck, arthritis, and fibromyalgia pain.
  • Sharpen your mind — Tai chi can help reduce age-related cognitive decline ... and even slow dementia!
  • Build confidence — While gaining muscle and mind control.
  • And so much more.
You’ll discover why tai chi has proven to be one of the most powerful ways to improve both your physical and mental health — why it’s often called “meditation in motion.” You’ll get gentle guidance through three choreographed routines designed to restore both your body and mind ... and to help you function better all day, each and every day, including one you can do in the comfort of a chair or your bed. Better yet, over 125 step-by-step photos show you exactly how to do every move correctly. Plus, helpful links to online videos — you can watch and follow along — make it almost seem that you’re in your own private tai chi class. And, if that weren’t enough, dozens of tips and techniques point out how to practice each move slowly and safely.
Don’t miss out on the myriad benefits tai chi has to offer, whether you’re in your 50s ... 60s ... 70s ... or more, in minutes just a few times a week. Order An Introduction to Tai Chi, and learn how to balance your mind and body — PLUS save 30% OFF the regular $29 price! There’s no risk. Order now!
Read More
Sincerely,
Howard E. LeWine, M.D.
Chief Medical Editor, Harvard Health Publishing
P.S. How good is your balance? You’ll find a quick technique to steady yourself — anytime, anywhere — on page 10 of your Special Health Report. Click here to order now!

Health News and Information - News Medical :: Radiology - Apr 24, 2018 Edition

Health News and Information - News Medical

 
 April 24, 2018 
 Radiology 
 The latest radiology news from News Medical 
 Shorter courses of radiotherapy found to be safe, effective for prostate cancer patientsShorter courses of radiotherapy found to be safe, effective for prostate cancer patients
 
Radiotherapy given in high doses over a shorter period of time is safe and effective for prostate cancer patients, according to research presented at the ESTRO 37 conference today.
 
   Targeted radiotherapy found to be a good option for women with early breast cancerTargeted radiotherapy found to be a good option for women with early breast cancer
 
Quality of life for women treated with a more targeted radiotherapy treatment - called accelerated partial breast irradiation - is at least as good as quality of life for women treated with standard radiotherapy, according to research presented at the ESTRO 37 conference and published simultaneously in The Lancet Oncology.
 
   Slight changes in patient's position during radiotherapy may impact survival chancesSlight changes in patient's position during radiotherapy may impact survival chances
 
Very small differences in the way a patient lies during radiotherapy treatment for lung or oesophageal cancer can have an impact on how likely they are to survive, according to research presented at the ESTRO 37 conference.
 
 What is X-Ray Brachytherapy?
 
What is X-Ray Brachytherapy?X-ray brachytherapy is a form of short-range radiation therapy used locally for the treatment of tumors. The technique involves a minimally invasive procedure to insert an X-ray tube at the target site followed by application of the radiation to destroy the cancer cells selectively.
 
 
 Functional connectivity MRI could help detect brain disorders and diseases
 
Functional connectivity MRI could help detect brain disorders and diseasesThere are no laboratory tests to diagnose migraines, depression, bipolar disorder and many other ailments of the brain. Doctors typically gauge such illnesses based on self-reported symptoms and behavior.
 
 
 Novel method enables fast and noninvasive assessment of tumor status
 
Novel method enables fast and noninvasive assessment of tumor statusHow aggressive is a tumor? To measure the tumor status without taking tissue samples, Italian researchers have developed a method based on magnetic resonance imaging (MRI) of whole body parts.
 
 
 Study confirms no survival benefit of adding SIRT to standard treatment for liver cancer
 
Study confirms no survival benefit of adding SIRT to standard treatment for liver cancerThe final results of the palliative cohort of the SORAMIC study in patients with unresectable, locally advanced primary liver cancer have confirmed no clinical advantage to adding selective internal radiation therapy to standard sorafenib treatment compared with using sorafenib alone.
 
 
 What are Microbubbles?
 
What are Microbubbles?Microbubbles are small, gas-filled bubbles, that are widely used as contrast agents in medical imaging and as carriers for targeted drug delivery.
 

Live Social Media Events | NCCIH

Live Social Media Events | NCCIH

National Center for Complementary and Integrative Health (NCCIH)

Addiction Twitter Chat 2018

Please join NCCIH and the National Institute for Alcohol Abuse and Alcoholism (NIAAA) tomorrow, April 25, from 3 to 4 p.m. Eastern Time for a Twitter chat about substance use disorders and their treatment, including the use of mindfulness meditation.

Experts, including NCCIH Acting Director Dr. David Shurtleff and Dr. Lori Ducharme, lead developer of NIAAA’s Alcohol Treatment Navigator, will be available to answer your questions. Join the conversation on Twitter using the hashtag #AddictionChat.

Find out more

A Potential Anticancer Drug From Poppies Has Been Produced in Genetically Engineered Yeast | NCCIH

A Potential Anticancer Drug From Poppies Has Been Produced in Genetically Engineered Yeast | NCCIH

National Center for Complementary and Integrative Health (NCCIH)

Poppy



Researchers from Stanford University and collaborating institutions have successfully synthesized noscapine, a potential anticancer drug, in yeast cells. This research, which was partially supported by the National Center for Complementary and Integrative Health, was published in a recent issue of the Proceedings of the National Academy of Sciences.

Noscapine, a nonnarcotic cough suppressant that is also being investigated as a potential anticancer drug, currently has only one source—the opium poppy. Because environmental factors such as pests, disease, and climate can threaten the poppy crop, which is only grown in a limited geographic area, other ways of producing noscapine are needed to ensure a stable supply of the drug.

Read the full Research Spotlight

Biohackers navigating a world of wonder and potential peril | Genetic Literacy Project

Biohackers navigating a world of wonder and potential peril | Genetic Literacy Project

Genetic Literacy Project

Biohackers navigating a world of wonder and potential peril

 |  | April 24, 2018
biohack 4 13 18 1