Category Archives: Genetics

Genentech Files Petition with FDA Urging Regulation Over All In Vitro Diagnostic Tests Aimed for Use in Therapeutic Decision Making

Posted on by
Reply

Tim WelchBy Tim Welch

The biotechnology company Genentech filed a 31-page citizen petition on December 9, 2008 urging the Food and Drug Administration (FDA) to regulate all in vitro diagnostic tests aimed for use in therapeutic decision making.  Under the current regulatory system used by the FDA, there are two types of in vitro diagnostic tests: those that are developed by device manufacturers and sold as diagnostic test "kits," and those that are developed by clinical laboratories for use within the laboratory ("in-house").  The FDA has regulated the former, while it has not regulated the latter.  This allows developers of "in-house" diagnostic tests to make claims about the accuracy, validity, and effectiveness of their tests which are not subjected to the same scientific scrutiny from the FDA that is required of similar test "kits."  Genentech argues in the petition that this regulatory inconsistency poses a serious threat to patients’ health because "the future of personalized medicine depends on the development of pharmacogenomic tests," and "it is critical that they are accurate, reliable, and clinically valid (i.e., effective)."

Continue reading →

Testing Children for “Sports Genes”

Posted on by
Reply

Lori Andrews by Lori Andrews

While some of us might be heading to the gym as we start the new year, certain parents are making another sort of resolution.  They are dialing up Atlas Sports Genetics and plunking down their credit cards to have their infants and toddlers tested for genes supposedly related to sports ability.  One woman who was considering such a test told The New York Times, “What if my son could be a pro football player and I don’t know it?”

As the denizen of a city famous for sports highs (Michael Jordan’s Bulls) and lows (the Chicago Cubs’ near misses), I am cautious about making predictions about a current team, let alone betting my hopes that a three year old will grow up to be the next Tom Brady or Peyton Manning.  And caution in this field should be the word of the day.  The proposed test raises both scientific and social issues.

Continue reading →

NIH Pulls Genetic Information from Internet after Research Shows Info Can Be Linked to Individuals

Posted on by
Reply

JulieBergerBy Julie Burger

For years, scientists have raced to unlock the mysteries hidden in the human genome. Relatively recent research methodologies, used in genome wide association studies (GWAS), are allowing scientists to much more rapidly uncover genes that may be linked to diseases. In GWAS, genetic and health information from thousands of people is compared to locate mutations or gene variants for diseases like breast cancer, diabetes and heart disease.  (For a scientific viewpoint as to why this research theory might not be successful, click here.)  Because this type of research calls for genetic and other information from thousands, or even tens of thousands of people, researchers are increasingly trying to tap into existing bodily tissue samples and private medical data from blood or biopsy samples taken at a physician’s office or hospital.  Researchers are also asking to share information from other researchers’ studies.  What many people don’t realize is that information about them and their genes could be taken and shared among researchers or even posted on the internet.

Researchers’ quest to correlate genes with disease has encouraged government agencies to implement policies to increase the sharing of genetic samples and genetic and health information even where the individual has not explicitly consented to the secondary use. The National Institutes of Health (NIH) has implemented a plan to increase access to genetic and associated health information. Starting in January 2008, researchers who received government funding for GWAS were required at the end of the study to submit the genetic profile and associated information about the health of the people whose tissue was used. The health information might be blood pressure or weight, or it might be information about drug use, mental health, and it could include information about family relationships.

Continue reading →

Holiday Gift Giving: Should You Give Your Loved One A Genome Scan?

Posted on by
Reply

Lori Andrews by Lori Andrews

With TIME Magazine dubbing the 23andme personalized genome scan the “2008 Invention of the Year,” you might be tempted to give your loved one his or her genetic profile for the holidays.  After all, what says I love you more than letting that special someone peek inside their own genome?  Or what about setting aside your usual New Years Eve revelry and sponsoring a spit party—where your guests can get an on-the-spot genetic tests?

The initial idea for a genetic profile as a gift did not originate with an entrepreneur or scientist, but with an artist. When the wife of a patron of arts asked Iñigo Manglano Ovalle to create a surprise portrait of her husband for his birthday, Ovalle conspired with the patron’s barber to pluck some hair from the man’s head and test it genetically.  Ovalle’s painted bands, based on the test results, looked like the forensic profiles used at the time in law enforcement and revealed no health information.  But the testing techniques used to produce the $399 genome scan offered by 23andme, as well as the tests offered by its competitors deCODE Genetics and Navigenics, do reveal potential future conditions including blindness, cancer, and risks of mental illness.

Continue reading →

Should Native American Identity Be Based on Genetics?

Posted on by
Reply

Lori Andrews by Lori Andrews

In the 1700s and 1800s, runaway slaves joined Native American tribes like the Cherokee and Seminoles.  For generations, these black men and women were full-fledged members of the tribe, taking up arms on the side of the Indians.  In modern times, the African-American members of the Native American nations, known from the beginning as Cherokee Freedmen and Seminole Freedmen, have continued to live on reservations and serve as tribal councils.

As Native Americans gain funds from casinos and from lawsuits against the government for past misdeeds, some tribes are looking for ways to limit membership.  When the Seminoles received a settlement of $96 million from the federal government for land unjustly taken from them, the tribe did not allow the African-American Indians, the Freedmen, to participate.  And last year, the Cherokee tribe voted to revoke the tribal citizenship of the Freedmen.  By stripping over 2,700 Freedmen of their tribal membership, the Cherokees denied them health care access, money for schooling and other Native American benefits.

Continue reading →

Can Genetic Technology Finger Errant Dog Owners?

Posted on by
5

Tim WelchBy Tim Welch

To scoop, or not to scoop?  That is the question.  Residents of two towns in Italy and Israel may be facing potential fines if they opt for the latter.  City officials in Vercelli and Petah Tikva are taking advantage of genetic testing technology to promote cleanliness in their municipalities.  They are creating DNA databases of all registered dogs and testing droppings left behind on the streets.  Finally fed up with owners who carelessly leave behind their puppies’ poop in public areas, these two cities will hand out fines to any citizen whose dog is identified as a match in the database.  The Israeli program also offers incentives to pet owners who place their dogs’ waste into special municipal bins.  Incentives include dog toys and pet food coupons.

In Vercelli, a small northern Italian city of 45,000 residents, the lack of attention to current laws regarding cleaning up after pets prompted the idea for a doggy DNA database.  “If signs and invitations aren’t enough, we’ll try genetics.  I want a clean city,” said Antonio Prencipe, a city councilor.

Continue reading →