NewsletterSept10.doc - Chapter Virtual Community - Oncology by liamei12345


									                            Oncology Nursing Society
                           Fort Worth Regional Chapter  
 866-257-4ONS, toll free             September 2010

President’s Corner
I have been thinking about how and when to find time to obtain CEU’s. I wanted to
remind everyone that has the CE Central. Many CE’s are free because of
sponsorship of drug manufacturers. Our local ONS virtual site references related
links at the bottom of the page. These links also offer CEU's. CME Corner
( is another excellent resource. When needing to obtain
general information for your daily practice, don’t forget to utilize your peers. The
facility that I work at has many wonderful nurses with years of experience. If they
do not know the answer, they usually have a resource that does.

I hope that your local chapter has met your professional needs this year. See you at
the September meeting.

Announcement:                                       Officers 2010
                                                    President: Rhonda Ford
Board members please plan to stay after the         President -Elect: Suzy Lockwood
September meeting for a board meeting.              Secretary: Tracy Messing
Thank you                                           Treasurer: Michelle Grodi
                                                    Program Committee Chair: Sherry Plunkett

                                                    Membership/Nominating Committee Chair –
                                                    Dawna Stankus
                                                    Scholarship Chair: Jenny Ellis
                                                    Newsletter editor: Monique Lounethone
                                                    Virtual Community Administrator:
                                                    Judy Goldthorp
                                                    Community Outreach: Michelle Grodi

Program Chair
September meeting will take place on the 13th due to Labor Day Holiday on September 5th.
Location: Pappadeaux Seafood Kitchen
Topic: “Why Does the Choice of Vascular Access Device Matter?”

October 4th meeting will be held at Bistro Louise. “Nursing Issues for Patients Using XELODA”
Speaker: Jody Pelusi, PhD, FNP, AOCN (Oncology Nurse Practitioner) from Sedona, AZ. Please
check the Fort Worth ONS website regularly for updated information.

Looking for Oncology job?
There is a classified section on the Fort Worth ONS website where jobs are posted for those of
you who are looking to change your career path.

September is:
Childhood Cancer Month                              Ovarian Cancer Awareness Month                    
.aspx                                               Prostate Cancer Awareness Month
Leukemia & Lymphoma Awareness             
Month                                         National Mesothelioma Awareness Day
National Sickle Cell Month                

30th ANNUAL ONCOLOGY NURSES                         8th ANNUAL ONCOLOGY
September 26-29, 2010                               NURSING ADVANCED
San Diego, California                               PRACTICE: Innovation through                  Practice
                                                    March 4-6, 2011
                                                    San Diego, California

                                                     ONCOLOGY NURSING SOCIETY
                                                     ADVANCE PRACTICE NURSING
                                                     November 11 – 13, 2010
                                                     Orlando County Convention Center
                                                     Orlando, Florida
                                                     CONFERENCE SCHOLARSHIP

Texas Health Presbyterian Hospital Allen Breast Cancer Conference
Texas Health Presbyterian Hospital Allen
Conference Center (Rooms 1 & 2)
1105 Central Expressway
Allen, Texas 75013
Saturday, October 23, 2010

Genetics Corner
                          Update on FDA Review of Genomic Testing

                                     Mary Pritzlaff, MS, CGC

                          Moncrief Cancer Institute/UT Southwestern

    On June 10, 2010, the FDA demonstrated its intent to regulate genomic testing when it sent
untitled letters to deCODE Genetics, 23andMe, Knome, and Navigenics. The letters specifically
target deCODE’s DecodeMe test, 23andMe’s Personal Genome test, Knome’s Knome Complete
test, and Navigenic’s HealthCompass test. These products are all SNP-based tests that evaluate
predisposition to a variety of conditions, including cancer, diabetes, heart disease, and
dementia. DeCODE’s DecodeMe test differs from the DecodeProstate test in that the former
tests SNPs for a variety of conditions, while the later tests SNPs exclusively for prostate cancer
risk. Also, the DecodeMe test is available directly to the consumer, while the DecodeProstate
test must be ordered through a healthcare professional. The FDA asserts that the cited tests
are considered medical devices, and therefore require review for safety and efficacy. Further,
the FDA asserts that these tests are considered to be in vitro diagnostic test kits (IVDs). Most
genetic tests are categorized as laboratory Developed Tests (LDTs). This distinction is
important, as IVDs require mandatory FDA oversight, while LDTs are only reviewed at the FDA’s

discretion. The FDA’s assertions that these tests are medical devices and IVDs open the door
for government oversight of the genomic testing industry.

    The FDA’s primary function in providing oversight of these tests is to ensure their clinical
and analytical validity. While virtually all of the genomic and genetic testing laboratories are
CLIA certified, this certification only address the laboratory’s testing procedures and laboratory
standards – it does not evaluate the validity of the tests themselves. In general, the FDA seems
most concerned about tests used for clinical diagnostic purposes that are available directly to
consumers without medical oversight. The FDA has not targeted genomic tests that are
ordered via healthcare professionals (such as deCODE’s Prostate Cancer test) or genomic tests
that have non-medical applications (such as 23andMe’s ancestry test). DeCODE Genetics,
23andMe, Knome and Navigenics have been asked to provide more information to the FDA in
order for the agency to review the safety, efficacy, and accuracy of their tests. They were also
invited to enter a dialogue with the FDA about which of their products may require federal
oversight. At the present time, these companies have not been required to shelve their
products, and are not yet facing legal action.

    The FDA has also sent an untitled letter to Illumina regarding their Infinium HumanHap550
array. In their letter, the FDA states that this array is labeled for research use only. They note
that Illumina is selling this array to deCODE Genetics and 23andMe for commercial use. The
FDA has asked Illumina to submit this product for review. If the HumanHap550 array is pulled
from commercial use, genomic testing may be impeded for the companies that rely on this

    In addition to the FDA’s actions, the House Committee on Energy and Commerce launched
an investigation of direct to consumer genetic testing on May 19 of this year. The House
committee requested information from 23andMe, Pathway Genomics, and Navigenics to aid
their investigation. Also, the Secretary’s Advisory Committee on Genetics, Health and Society
(SACGHS) recommended a mandatory genetic testing registry to create transparency for
genetics consumers and to aid in federal oversight. NIH is beginning the process of
implementing this registry with expanded data about analytical and clinical validity. The
outcome of the government’s investigations of direct to consumer genetic testing will likely
have wide-reaching effects on the industry. At the present time, the companies involved have
been cooperative in working with the FDA, although 23andMe has challenged the assertion that
their tests should be considered an IVD. The media has speculated that these companies will
continue to offer their tests, but may move away from the direct to consumer model as result
of government oversight. There is some speculation that deCODE may pull their DecodeMe
test, based on the company’s recent bankruptcy, their market price competitiveness, and their
long-term business model. The future of genomic testing will largely be shaped in the coming
months, as government and industry begin to address the important issues of consumer safety,
analytical and clinical validity, and medical innovation. For now, all of the involved laboratories
continue with business as usual.


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