Health

FDA Eases Access to DNA Screening for Inherited Diseases

Published

10 years ago

February 20, 2015

MATTHEW PERRONE, AP Health Writer

WASHINGTON (AP) — Federal health officials are easing access to DNA tests used to screen parents for devastating genetic disorders that can be passed on to their children. The surprise announcement offers a path forward for Google-backed genetic testing firm 23andMe, which previously clashed with regulators over its direct-to-consumer technology.

The Food and Drug Administration said late Thursday it will not require preliminary review before companies can sell so-called carrier screening tests to the public. The tests, currently administered by health care professionals, are used by prospective parents who are healthy but may be carriers of cystic fibrosis, Tay-Sachs and other rare familial conditions.

In the same announcement, the FDA said it cleared the first carrier screening test from 23andMe, which was forced to pull its health tests from the market in 2013 due to a lack of scientific evidence.

23andMe’s test screens for the genetic mutations that cause Bloom syndrome, a rare disorder that causes short stature, increased risk of cancer and a variety of other health problems. The disorder is more common in people of central and eastern European Jewish descent, affecting about 1 in 50,000.

The positive FDA decision is a victory for Mountain View, California-based 23andMe, which had recently become something of a poster child for the culture clash between Silicon Valley and Washington.

The company’s CEO Anne Wojcicki said in an interview that her company’s research demonstrates that patients can understand genetic testing results.

“Our user comprehension studies have shown that people can get this information on their own without a physician and that there’s potentially a real benefit to direct access,” said Wojcicki.

Bloom syndrome is one of about 250 conditions and diseases that 23andMe’s original DNA kit claimed to help screen for by analyzing users’ genetic code. Wojcicki says that her company has another 45 to 50 carrier screening tests that could return to the market under the FDA ruling, possibly later this year.

The FDA said in a statement it plans to file a notice of the change and will take comments from the public for 30 days.

“The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information,” said Alberto Gutierrez, director of FDA’s office for diagnostics.

People are considered a carrier for a genetic disorder if they have one normal gene and one mutated gene related to the disorder. A child must inherit two genetic mutations to fully develop the disorder.

23andMe launched in 2006 amid a flurry of publicity and celebrity endorsements, marketing its saliva-based test kit as an affordable way for consumers to peek into their own genetic code. But the company’s aggressive marketing and lack of scientific evidence ran afoul of FDA officials.

In November 2013, the FDA ordered 23andMe to stop selling its health tests. FDA said that despite over a dozen meetings and “hundreds of email exchanges” the company had failed to show the tests were backed by science. Regulators also took issue with a number of claims used to market the technology, particularly calling it a “first step in prevention” against diseases like diabetes, heart disease and breast cancer.

23andMe continues to sell genetic ancestral information and raw, unprocessed DNA data through its basic kit, which costs $99.

Wojcicki is separated from her husband, Google-co-founder Sergey Brin. Both Google and Brin have invested millions in the privately held company.

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Activism

LIVE! — TOWN HALL ON RACISM AND ITS IMPACT — THURS. 11.14.24 5PM PST

Join us for a LIVE Virtual Town Hall on the Impact of Racism hosted by Post News Group Journalist Carla Thomas and featuring Oakland, CA NAACP President Cynthia Adams & other Special Guests.
Thursday, November 14, 2024, 5 p.m. – 6:30 p.m. PST

Published

2 weeks ago

November 12, 2024

Oakland Post

Discussion Topics:
• Since the pandemic, what battles have the NAACP fought nationally, and how have they impacted us locally?
• What trends are you seeing concerning Racism? Is it more covert or overt?
• What are the top 5 issues resulting from racism in our communities?
• How do racial and other types of discrimination impact local communities?
• What are the most effective ways our community can combat racism and hate?

Your questions and comments will be shared LIVE with the moderators and viewers during the broadcast.

STREAMED LIVE!
FACEBOOK: facebook.com/PostNewsGroup
YOUTUBE: youtube.com/blackpressusatv
X: twitter.com/blackpressusa

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California Black Media

Gen. Election Update: Tracking Your Votes on Ballot Propositions — and What They Mean for Our Communities

In the Nov. 5 General Election, Californians cast their votes on ten propositions addressing issues from education and climate funding to prison labor and the minimum wage.

Published

3 weeks ago

November 6, 2024

Oakland Post

By Joe W. Bowers Jr., California Black Media

In the Nov. 5 General Election, Californians cast their votes on ten propositions addressing issues from education and climate funding to prison labor and the minimum wage.

Below is a breakdown of the propositions, their potential impact and an update on how we voted on them.

Likely to Pass:

Proposition 2: Bonds for Public School and College Facilities
With 56.7% support, Prop 2 is on track to pass. This measure would allocate $10 billion to repair and upgrade K-12 and community college facilities, especially in under-resourced schools. For students, this funding could lead to safer and more supportive learning environments.

Proposition 3: Constitutional Right to Marriage
Prop 3 currently has 61.4% support and is likely to pass. This measure aims to amend California’s constitution to affirm marriage rights for all. For LGBTQ+ individuals in our communities, this is a powerful affirmation of equality and inclusion.

Proposition 4: Bonds for Water, Wildfire, and Climate Risks
Currently passing with 57.8%, Prop 4 is on track to deliver $10 billion for projects that address water quality, wildfire prevention, and climate resilience. This could have a significant impact on communities that face the harshest effects of climate change.

Proposition 34: Restricts Spending of Prescription Revenues
Prop 34 is narrowly passing with 51.4% support, indicating that it may succeed. The measure would require specific healthcare providers to use 98% of revenue from federal drug discount programs on direct patient care. This could improve healthcare access for low-income residents.

Proposition 35: Provides Permanent Funding for Medi-Cal
With 66.8% of voters in favor, Prop 35 is on course to pass, securing permanent funding for Medi-Cal, California’s low-income healthcare program. For many in our communities who depend on Medi-Cal, this measure promises stability and continued access to essential healthcare services.

Proposition 36: Increased Sentencing for Certain Drug and Theft Crimes
With strong support at 70.5%, Prop 36 is poised to pass, increasing penalties for specific theft and drug offenses. This measure would partially roll back sentence reductions established by Prop 47, sparking concerns about potential increases in incarceration rates.

Likely to Fail:

Proposition 5: Bonds for Affordable Housing and Infrastructure
With 56.4% of voters opposed, Prop 5 is likely to fail. The measure aimed to reduce the voting threshold for local bonds from two-thirds to 55%, making it easier to fund affordable housing. Without it, local governments will continue to face higher approval requirements, potentially slowing progress on affordable housing solutions.

Proposition 6: Eliminates Forcing Inmates to Work
Currently failing with 54.9% opposed, Prop 6 is expected to be defeated. This measure would have ended involuntary labor for incarcerated individuals, a practice critics argue disproportionately affects Black inmates. It’s likely failure means the prison labor system will remain unchanged.

Proposition 32: Raises Minimum Wage
With 52.1% of voters opposing it, Prop 32 appears likely to fail. This measure would have raised the minimum wage to $18 an hour. While proponents argued it would provide greater financial stability for low-wage workers.

Proposition 33: Local Government Residential Rent Control
With 61.9% voting “no,” Prop 33 is expected to fail, meaning that local governments won’t gain expanded authority to enact rent control. Real estate groups argued that this measure could hinder housing development. Its failure means that current rent control laws will remain in place, leaving fewer protections for renters.

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California Black Media

Covered California Open Enrollment Began Nov. 1

Open enrollment for Covered California kicked off on Nov. 1, 2024, offering individuals, families, and businesses a chance to secure quality, affordable health insurance for the upcoming year. This annual enrollment period allows California residents to choose from a variety of health plans that meet their specific needs. Covered California offers comprehensive coverage, including preventive care and financial assistance to help eligible applicants lower their monthly premiums.

Published

3 weeks ago

November 6, 2024

Oakland Post

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By Bo Tefu, California Black Media

Covered California offers comprehensive coverage, including preventive care and financial assistance to help eligible applicants lower their monthly premiums. The program features insurance plans from leading providers, ensuring access to essential health services such as doctor visits, hospital care, and mental health services.

This year, notable updates include expanded financial assistance, which increases the support available for eligible households to help offset monthly costs. Additionally, consumers will find greater plan flexibility, allowing them to select options that fit their lifestyles and budgets. Access to no-cost preventive services — like vaccinations, screenings, and annual check-ups — remains a priority.

Key enrollment deadlines are set as follows:

The open enrollment period runs from Nov. 1, 2024, to Jan. 31, 2025.
Those who enroll by Dec. 15, 2024, will have their coverage start on Jan. 1, 2025.

To facilitate enrollment, applicants can fill out an inquiry form on the Covered California website, reach out to Certified Enrollment Counselors, or contact Covered California directly at (888) 234-5366 or via email at GetCovered@cbhn.info.

The California Black Health Network (CBHN) collaborates with Covered California to advocate for health equity, focusing on underserved communities, including unemployed and gig workers. CBHN’s certified enrollers engage in outreach and onsite signups to help individuals access affordable healthcare options.