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 LOH. This 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

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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 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 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 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? 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 There 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 How 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 The 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? 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

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

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.