Monday, January 13, 2014

After 23andMe, Another Personal Genetics Firm Is Charged with False Advertising

Original post by Dina Fine Maron on Scientific American, 1/11/14

It sounded like a miracle of science and convenience: swab your cheek and drop the saliva sample in the mailbox and GeneLink Biosciences, a personal genetics company, would analyze your DNA and send back nutritional supplements customized to your personal genome. The regimen, the company promised, was good for diabetes, heart disease, arthritis, insomnia and other ailments. The Federal Trade Commission (FTC), however, thought it sounded like false advertising and brought a lawsuit against the company, charging its claims were misleading and not founded in sound science.

The case is the latest in the continuing controversy over personal DNA testing services. Two months ago the U.S. Food and Drug Administration warned 23andMe to stop selling its personal genetics testing kits because the company failed to prove its tests worked and the agency worried about the public health consequences of inaccurate results. The GeneLink case, the FTC’s first against a personal genomics company, could serve as a shot across the bow to other similar businesses. Under the terms of a proposed settlement announced on January 7, Orlando, Fla.–based GeneLink agreed to stop making unsubstantiated health claims. The settlement, which would only take place after a 30-day public comment period and a final decision from the FTC, would keep GeneLink and its former subsidiary, foru International, from making any future claims that their products can impact the course of disease unless such claims are supported by two double-blind, randomized control trials—the gold standard of medicine. A violation of that agreement could lead to fines.

“What we’re alleging is that [GeneLink’s] claims got ahead of the science,” says Carolyn Hann, a lead attorney on the case for the FTC’s Bureau of Consumer Protection. “By taking action against GeneLink and foru we were trying to indicate to this industry we were aware of the claims being made and we wanted the industry to understand where we stand on these issues,” she says. The FTC could not comment on whether other cases against genetic companies are in the offing. Although the commission opened investigations into two other genetic firms in the past, both cases were closed before action was taken, in part because the outfits were no longer going to market their products in the U.S.

GeneLink and its former subsidiary, now an independent company, had claimed that they were sending cheek swab samples to a third-party laboratory for analysis of genetic variations called single nucleotide polymorphisms (or SNPs). The companies claimed they could examine specific SNPs that affect nutritional health and aging and then offer personalized nutritional supplements and skin health products. “Any claims at all that one can look at those SNPs or other SNPs and make any meaningful recommendations for nutrition, cosmetics or anything along those lines are just entirely unfounded and entirely without any scientific merit,” says geneticist James Evans, editor in chief of the journal of the American College of Medical Genetics and Genomics.

The heart of the controversy was GeneLink’s claims that its custom-blended supplements could help compensate for aging or mitigate health issues such as heart disease and arthritis.

Under this lawsuit the FTC also charged that GeneLink failed to adequately protect consumer’s personal data, including contact information, Social Security and credit card numbers, and genetic data. According to FTC documents, GeneLink and foru had obtained genetic information from nearly 30,000 consumers since 2008. The proposed agreements would force the firms to set up comprehensive information security programs to protect such consumer data in the future and to assign at least one employee at each company to oversee that program. The corporations would also be required to receive initial regular external audits to check that the information is secure. The FTC cannot file criminal charges, only civil suits.

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Thursday, January 2, 2014

U.S. Preventive Services Task Force Finds Benefit in Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related Cancer for Small Group of High-Risk Women

WASHINGTON, D.C. – December 24, 2013 – The U.S. Preventive Services Task Force (Task Force) today published its final recommendation on risk assessment, genetic counseling, and genetic testing for BRCA-related cancer in women. The Task Force recommends that women with family members who have had breast, ovarian, tubal, or peritoneal cancer talk with a health care professional to learn if their history might put them at risk for carrying a BRCA mutation. Women who screen positive should receive genetic counseling and, if indicated after counseling, BRCA testing. Additionally, for the vast majority of American women (90 percent), who do not have a family history associated with an increased risk for the inherited mutations, the Task Force continues to recommend against genetic counseling and testing.

One important step in preventing BRCA-related cancer is helping women understand their risk. Mutations in the BRCA1 and BRCA2 genes, which are present in 0.2 to 0.3 percent of women, are just one of many factors that can increase a woman’s risk for developing breast and ovarian cancer. Women with these potentially harmful mutations can have up to a five times greater chance of developing breast cancer, and BRCA mutations can also increase a woman’s lifetime risk for ovarian cancer to as high as 40 percent.

“Too many American women and families are faced with the challenge of dealing with cancer diagnosis and treatment. We have great hope in the science of genomics to improve screening practices and even prevent some cancers,” says Task Force chair Virginia Moyer, M.D., M.P.H. “At this point, the evidence shows that most American women will not benefit from genetic counseling or the test for gene mutations in BRCA1 and BRCA2. For women who have a family history that might be associated with an increased risk for these mutations, we found that some may benefit from in-depth genetic counseling that thoroughly reviews their family history and, if indicated and after weighing the pros and cons of BRCA testing, receiving the test.”

Current tests work best for women at a high risk for developing cancer, but the test alone does not always provide a definitive answer. There are some harms of testing; results are often inconclusive and many women could be burdened with the uncertainty of whether they are—or are not—at an increased risk for cancer. Inconclusive genetic testing leads many women to choose to take powerful medications or undergo major surgery to reduce their risk for developing cancer. Unfortunately, most will not benefit from these interventions and may needlessly suffer great harm, especially because they were never at increased risk to begin with. Therefore, the Task Force continues to recommend against routine genetic counseling and BRCA testing in women without a strong family history of cancer.

“Evidence still shows that there are serious, negative consequences that could result from testing women who are at low risk for BRCA mutations. The BRCA test works best for women who have reviewed their family history of breast or ovarian cancer and the pros and cons of the screening test with a trained professional,” says Dr. Moyer. “We hope further research will improve the ways genomic science can help women and their doctors understand their risk for cancer.”

The Task Force’s final recommendation statement is published online in Annals of Internal Medicine, as well as on the Task Force Web site at A fact sheet that explains the recommendation statement in plain language is also available. A draft version of this recommendation was available for public comment in April 2013.

The Task Force is an independent, volunteer panel of national experts in prevention and evidence-based medicine that works to improve the health of all Americans by making evidence-based recommendations about clinical preventive services such as screenings, counseling services, and preventive medications.

Contact: Ana Fullmer at / (202) 350-6668

Click here to read the original bulletin by The U.S. Preventive Services Task Force
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CMS Cuts Reimbursement for BRCA1/2 Testing by 49 Percent; Analyst Downgrades Myriad Shares

Original post on GenomeWeb, 12/30/13

NEW YORK (GenomeWeb News) – The Centers for Medicare and Medicaid Services updated its reimbursement level for BRACA testing at $1,438 for 2014, a slash of nearly 49 percent from a previous level of $2,795.

As a result, investment bank Mizuho Securities today downgraded its rating on Myriad Genetics' shares to Hold from Buy and cut the price target on the company's stock to $24 from $36.

In morning trading on the Nasdaq on Monday, shares of Myriad fell 16 percent to $20.18.

In a document filed with the US Securities and Exchange Commission today, Myriad said CMS posted a National Limit Amount of $1,438.14 for CPT code 81211, which covers a test for the full sequencing of the BRCA1 and 2 genes, and for CPT code 81214, which covers a full sequencing of only the BRCA1 gene. No payment rate was set for CPT code 81216, which covers a test for the full sequencing of the BRCA2 gene.

The payment rates for 81211 and 81214 become effective "on or after" Jan. 1, 2014, CMS said.

CMS has opened a public comment period through Jan. 27, 2014, "[a]s the public has not had the opportunity to provide comment on the new NLA for 81211," Myriad said, adding it plans "to address a number of both substantive and process concerns" during the comment period.

"It is unclear why CMS has not valued the BRCA 2 gene in the 81211 code," the Salt Lake City-based company said. "It is also unclear how CMS arrived at the 81211 payment rate within the requirements of the federal gapfill regulations."

In September CMS posted an NLA for Myriad's BRACAnalysis test of $1,449 for the remainder of 2013, suggesting that that rate would last into 2014. Two Medicare contractors, however, quickly said that they had committed an error in setting the $1,449 figure.

In its new BRCA1/2 NLA document posted on Friday, CMS cited the decision by the US Supreme Court in June that invalidated certain claims on patents covering the BRCA1/2 genes held by Myriad. Before the SCOTUS decision, Myriad was the only laboratory offering BRCA testing, but since the judgment a number of firms, including Quest Diagnostics, Laboratory Corporation of America, and BioReference Laboratories' GeneDx business, have launched their own tests.

Medicare's Administrative Contractors (MAC) have received pricing data from the labs offering BRCA testing, and "[b]ased on the new information, the MACs submitted pricing information for CPT code 81211 that resulted in an NLA of $1,438.14," CMS said.

"At present, it is our understanding laboratories are offering the CPT code 81211 test for prices that range from approximately $900 to $2,900. As CPT code 81214 is similar to CPT code 81211, the additional comment period will apply to both CPT codes 81211 and 81214," CMS added.

Mizuho analyst Peter Lawson today downgraded Myriad's shares following the reimbursement cut, saying that although Medicare accounts for only 10 percent of Myriad's BRCA revenues, "CMS pricing has increased the fear that private payors may also cut pricing."

While the reimbursement rate may increase after the public comment period, "we are cautious on that outcome," Lawson said.

Leerink Swann analyst Dan Leonard added that even if BRCA testing reimbursement is increased, any increase will not take effect until after April 1, 2014. "[T]hus, the lower payment rate for 81211 will occur at least through" March 31, 2014, he said in a research note.

He maintained a Market Perform rating on Myriad's shares with a $25 price target.

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