Doctor End Medicine Mouse Naked Reboot Silicon Valley Will

As readers of Genetics and Health know, I am vocal in my support of providing patients with a wealth of education, information and advice before, during and after they undergo a genetic test.

With this in mind, Navigenics is a company I have had my eye on for some-while.  The company offers a comprehensive SNP based genetic risk assessment screen but has placed great emphasis on the ‘preventative health, wellness and ongoing support’ aspect for its customers and members.

Navigenics kindly agreed to be interviewed on all aspects of the company’s service, its philosophy and also provided comment on the various ethical and scientific debates that are currently raging around the whole subject of genetic testing.

Watch this space! ….

Elaine Warburton  www.geneticsandhealth.com

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It’s been quite a month for genetics and ethics!  There has been much commentary on GINA (Genetic Information Non discrimination Act) and now an influential academic group have developed an ethical framework of recommendations to encourage individuals to join whole-genome association studies.

According to a large group of genomics scholars, researchers, ethicists, and policy designers and watchers, in order to live up to its potential, whole-genome research in the future should be built upon some ETHICAL foundation that will give people the confidence and trust they will need in order to become volunteers.

The group of experts published a statement of consensus this week in PLoS Biology that is intended to serve as practical guidance for scientists involved in whole-genome association research and for ethics boards. The statement proposes eight recommendations aimed at creating more secure and consensual practices for research institutions involved in whole-genome association studies.

In summary, they are:

1. Detailed consent from volunteers for future use of their genetic material that includes as much detail as possible, including information about the sampling and sequencing process, associated commercialization activities, possible risks, and the nature of likely future research initiatives. Option for volunteers to re-consent for specific projects.

2. The right to withdraw consent, including the destruction of tissue samples and written information, must, so far as possible, be respected and be part of the whole-genome research ethics process. In addition, the fact that this right may be severely limited once data are disseminated must be clearly communicated as part of the initial informed consent process.

3. The design of personal genome projects and ethics review should explicitly consider how the ability to withdraw from subsequent use is enhanced or diminished by how data and samples are collected, stored, and disseminated. The appropriate balance will need to be considered for each project on a case-by-case basis.

4. Personal genome research projects should have an established process, approved by a research ethics review entity, for evaluating whether findings (incidental or otherwise) meet criteria for offering to individual participants. This process should be highlighted in the initial consent and should acknowledge the participants’ right not to know certain results.

5. The process of identifying and disclosing research results should involve professionals with the appropriate expertise required to provide the participant with sufficient interpretive information.

6. Data release policies must be designed to appropriately balance the benefits and requirements of access against the privacy interests of research participants. The rationale for the proposed data release policy needs to be clearly explained, justified as necessary for the goals of research, and deemed acceptable by the relevant ethics review entity.

7. The implications of data release must be adequately disclosed to the potential participants in the consent process. This disclosure should include a discussion of the likely finality of the release process and the implications that this may have on privacy and the future right to withdraw.

8. As part of the consent and ethics review process, the issues associated with family members and relevant groups and populations should be considered (this may, for example, involve encouraging/requiring discussions with family members).

For further information, please click on the following link:

http://biology.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pbio.0060073

Elaine Warburton  www.geneticsandhealth.com

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(Picture courtesy of BBC News)

Scientists have discovered the oldest human remains in western Europe.

A jawbone and teeth discovered at the famous Atapuerca site in northern Spain have been dated between 1.1 and 1.2 million years old.

Scientists also found stone tools and animal bones with tell-tale cut marks from butchering by humans.

Its small size suggests it could have belonged to a female.

The finds provide further evidence for the great antiquity of human occupation on the continent, the researchers write in the journal Nature.

Elaine Warburton  www.geneticsandhealth.com

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 VereFluanalyser

A joint venture between a microelectronics company and a medical diagnostics company has produced the world’s first “lab-on-chip” portable device for detecting various types of flu, including bird flu, at the point of need.

The launch of VereFlu, described as a “breakthrough molecular diagnostic test that can detect infection with high accuracy and sensitivity”, was announced on Monday by its makers, STMicroelectronics of Switzerland and Veredus Laboratories of Singapore. The device was successfully trialled at the National University Hospital of Singapore.

Unlike existing diagnostic methods, VereFlu is a breakthrough molecular diagnostic test that can detect infection with high accuracy and sensitivity, within two hours providing genetic information of the infection that traditionally would take days to weeks to learn. With its high level of automation, users outside the traditional lab environment can easily perform the tests at the point of need.

The device integrates two powerful molecular biological applications to identify and differentiate, using a single test, human strains of Influenza virus types A and B, and the H5N1 strain of Avian Flu.  This portable “mini-lab” allows the diagnostician to analyze a patient sample like blood, serum and respiratory swabs, on a single disposable thumbnail-sized chip.

The cost of the VereFlu test is comparable with other existing tests in the market although a spokesperson did not provide any specific price. It is understood that a single PCR test is priced around Sing$100 (US$72), including specialized labor costs for testing.

Elaine Warburton  www.geneticsandhealth.com
 

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Following my article on GINA (Genetic Information Nondiscrimination Act), the influential doctors’ group, the American College of Physicians (ACP), wants the GINA to become law.

The ACP does not directly address the concerns of employers or health insurance companies, but sides with the GINA supporters on individual rights to insurance protections. The ACP agrees that insurance providers should not be able to use an individual’s genetic information to deny or limit health coverage or establish eligibility, enrolment, or to set requirements. In addition, ACP said insurers should be prohibited from setting different premium rates based on an individual’s genetic information.

ACP also said it should be illegal for employers and insurers to require individuals or their families to undergo genetic testing and that written and informed consent should be mandatory for disclosure of genetic information. 

Conversely the insurance industry group American Health Insurance Plans has said it that although it supports the passage of a genetic discrimination law, GINA is not quite the law it wants.  The Group’s spokesperson William Corwin, the medical director of clinical policy at Harvard Pilgrim Health Care, said the law could get in the way of “appropriate health care decision-making.” He also advised that the Group had expressed concerns that there may be many “unforeseen advances” that could create circumstances where insurance companies would “need to request genetic tests to determine whether customized therapies or treatments are warranted.” Corwin also said GINA would stop health insurers from using genetic testing to identify “patients who may benefit from specific types of screening or disease management services”

The Personalized Medicine Coalition, which is comprised of R&D Universities and hospitals, clinical lab testing companies, patient advocacy groups, and government partners, has consistently backed the adoption of such a law.

Elaine Warburton  www.geneticsandhealth.com

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