From FDA website: "As required by the 2012 FDA Food Safety and Innovation Act, the FDA is providing 60-day notice to Congress prior to issuing draft or final guidance on the regulation of laboratory tests. At the same time, the FDA is posting, for public viewing, the draft proposal provided to Congress regarding LDTs (Notification to Congress: FDA’s Laboratory Developed Tests Framework - July 31, 2014).
After this 60-day notice, the FDA intends to issue a draft guidance, which will be open for public comment for 90 days. The FDA will publish a notice in the Federal Register when the draft guidances are released. The agency also intends to hold a public meeting during the comment period to collect additional input. When the FDA schedules the public meeting it will be announced in the Federal Register notice. The FDA values input on these proposals. Please refer to this website for future notices regarding the comment period and any related meetings."
As I understand it, myriad has already submitted companion testing to the FDA for Parp related testing.
The FDA has the broadest authority in terms of regulating the safety and effectiveness of genetic tests as medical devices under the Federal Food, Drug, and Cosmetic Act. Whether FDA regulates a test is determined by how it comes to market. A test may be marketed as a commercial test "kit," a group of reagents used in the processing of genetic samples that are packaged together and sold to multiple labs. More commonly, a test comes to market as a laboratory-developed test (LDT), where the test is developed and performed by a single laboratory, and where specimen samples are sent to that laboratory to be tested. The FDA regulates only tests sold as kits and, to date, has practiced "enforcement discretion" for LDTs.
can't post link!
"More than 30,000 men will die from prostate cancer this year, so there is an urgent need to improve clinical care for patients," said Brawer. "Prolaris adds real value to the healthcare system by reducing unnecessary surgeries or exposure to radiation for men at low risk, while increasing medical interventions for men with aggressive prostate cancer, which we believe will save and improve more lives and potentially save the healthcare system more money."
from website -
Prolaris–A prognostic test for prostate cancer.
Prolaris®, a novel prognostic test developed by Myriad Genetic Laboratories, directly measures tumor cell growth characteristics for stratifying the risk of disease progression in prostate cancer patients.
Prolaris is a risk stratification tool for patients with prostate cancer. It can enable you to better define a treatment/monitoring strategy for your patients with prostate cancer, enhancing their quality of life without jeopardizing their life expectancy.
Prolaris provides a quantitative measure of the RNA expression levels of multiple genes related to the progression of tumor cell division.
The 46-gene expression signature includes cell cycle progression genes selected based upon correlation with prostate tumor cell proliferation: low gene expression is associated with a low risk of disease progression and high gene expression is associated with disease progression.
Prolaris can identify low or intermediate-risk patients who may be candidates for surveillance as well as patients who may be potentially at higher risk and benefit from closer monitoring or additional therapy.
Prolaris has been proven to predict prostate cancer-specific disease progression in 4 published clinical trials.
I have posted it repeatedly, you choose not to acknowledge or understand a 30% reduction in aggressive therapy (surgery and radiation) is worth huge money to CMS and saves on side effects for the male patient.
Prostate cancer is very prevalent 60% in 60 y.o. prostates, 70% in 70 y.o prostates, 80% in 80 y.o. prostates. What to do about it is the dilemma, especially if there is other serious chronic disease present. Physicians don’t know whether or not to be aggressive with therapy or take a wait and see approach. Side effects of the therapies are really nasty.
So….successfully stratifying the men into high and low risk is the holy grail. as one practicing urologist put it - Prolaris is a game changer.
I hope you are never faced with the decision of how aggressively to treat early stage prostate cancer.....
Forward P/E (fye Dec 29, 2015)1: 61.55
PEG Ratio (5 yr expected)1: 3.75
Price/Sales (ttm): 14.74
Price/Book (mrq): 22.00
what would the stock price for mygn be if had the same measured values/ratios as ilmn
current price $37.51
Forward P/E (fye Jun 30, 2016)1: 16.90 $136.61
PEG Ratio (5 yr expected)1: 1.24 $113.43
Price/Sales (ttm): 3.49 $158.42
Price/Book (mrq): 3.81 $216.59
average about $156.26!!
difference between today's price and the potential is due to short position IMHO.
Question IPR3100: May a patent owner challenge the standing of a petitioner in the preliminary response?
A patent holder may challenge the standing of a petitioner in the preliminary response. For example, a patent holder may provide evidence that the petitioner has filed a civil action challenging patentability prior to filing the petition or that the petitioner otherwise is estopped from challenging the patent owner’s claims.
Question IPR3020: Who may file for an inter partes review?
A person who is not the patent owner and has not previously filed a civil action challenging the validity of a claim of the patent may petition for an inter partes review of the patent.
mygn closing stock price now above closing price on 8/1/2014 (prior to run up before earnings call)............