Simple Cancer Biomarkers are Inadequate to Enable Personalized Medicine

It seems that researchers are finding that using single cancer biomarkers to develop companion diagnostics (CDx’s) to be used with future targeted therapeutics is very challenging. An article in the November 15 issue of Genetic Engineering and Biotechnology News, called Traversing the Cancer Biomarker Labyrinth, by Kathy Liszewski, is a very interesting read.

Apparently progress in this field has slowed in finding clinically useful biomarkers for diagnostics and making other tests that guide doctors for disease prognosis and prediction. Researchers are using a variety of reductionist technical approaches that range from analysis of certain glycans, key microRNAs, and epigenetic changes, to big data analysis of massive data stores of genomic data to tease out more clues to what is going on in cancers.

Scientists seek to develop early detection blood tests that can detect cancers of interest.  Such a blood test could be considered a ‘liquid biopsy’ and might include a panel of a dozen or more miRNAs that represent a biomarker signature.  An oncologist might one day be enabled to quickly screen certain patients with a blood test that would help them diagnose, stage or predict the potential outcome of a cancer.

Achillion vs. Actelion More Biotech M&A’s to Come

Last week’s announcement by Swiss drug maker, Roche Holding AG, that it was buying biotech firm InterMune, Inc. for $8.3 billlion sparked speculation by industry watchers about who would be the biotechs that might be involved in the next round of M&As. InterMune makes a drug, Esbriet (pirefnidone) that treats a lung condition, idiopathic pulmonary fibrosis. Esbriet is approved in Canada and Europe. The drug has the potential to become a blockbuster seller. InterMune’s product would join Roche’s Pulmozyme and Xolair to build up its lung drug portfolio.

A number of names popped up such as Achillion Pharamaceuticals, Actelion, Puma Biotechnology, Intercept Pharmaceuticals, and others. Maybe people heard Achillian but were attracted to similar sounding Actelion.

• Achillion Pharamaceuticals makes Phase II hepatitis C virus (:HCV) candidate, ACH-3102.
• Puma Biotechnology is developing its Phase III breast cancer candidate neratinib, PB272.
• Intercept Pharmaceuticals makes its phase II nonalcoholic steatohepatitis drug, obeticholic acid, OCA.
• Actelion Pharmaceuticals makes a cancer drug to treat a rare form of non-Hodgekin’s lymphoma.

Some in the big pharma side are still holding out hopes of buying a biotech that can make their next blockbuster. So which will it be? Achillion? Actelion? Others? To be sure, we will need wait and see.

Pros and Cons of Sharing Personal Genomes on Social Media

I recently particpated in an online conference session held by NGS Leaders when CHI held its Beyond Sequencing conference in San Francisco recently on June 21, 2011. The session was moderated by NGSLeaders’ Eric Glazer and a panel of NGS experts.  The panelists included Kevin Davies, PhD.(Bio-IT World) Pillar Ossorio , PhD. (Univ. of Wisconsin), Johnathan Eisen, PhD, (UC Davis), and Kamamiesh (Kam) Patel, PhD. (Sandia National Labs).  This panel session was about “When People Share Their Genomes on Facebook.”  Both Kevin and Kam participated by telephone and the others were with a live audience in the meeting room.  The session used WebEx to link remote participants.

Kevin summarized the recent history of personal genomics services since the field was started by 23andme.com and deCode Genomics.  He pointed out that these services were marketed as services that enabled consumers to learn much about their genetic make up.  The services just provide information that might help people learn more about their risk for common disease or for geneology.  The customers’ genetic information is not to be used as a diagnostic. While the technology is initially based on microarrays and SNPs, some companies hoped to use NGS when the cost gets low enough.  However, Kevin said that the future of personal genomics is still in the hands of the FDA to decide on guidance to the industry.  Johnathan predicted that we will see a lot of push inside of genomes and personal microbiomes.  Microbiomes are the total kinds of microscopic things that live in or on our bodies.

As the discussion turned to social media, Kam said that the social media giants have big potential uses for health information.  A person could meet with their doctor, then the doctor could later access the person’s Facebook page and follow the progress of a treatment regimen.  But there are pros and cons to watch out for such as exploiters and cost issues.

Johnathan spoke about ‘crowd sourcing’ would be useful for health information.  He said that Facebook is only partly open.  He noticed a new push for open science such as to post lab notebooks on a social media site.  As for citizen science, he predicted that personal genomics, open science projects and citizen science will merge together.  When that happensm then anybody can make or use the information for their own open science projects.

A big question is who owns the personal genetic information held on social media sites.  Pillar, a lawyer, said that  we can think about this in terms of copyrights and patents.  She said that for example, when I get genetic information, I might just get a license for personal use, — it might be limited or unlimited.  The media site rules migth determine who can use the information, etc. At least we have the GINA law to protect our rights regarding employment and insurance discrimation.  However, she thinks that much of this is unknowns.  Pilliar said that the courts would likely say that if you put your genetic information on a public social media site, you are effectively giving away information to the public domain.  She said that people need to be educated about the subject so people would know who should participate.  She said that George Church has a screening process to weed out ignorant people.  He makes applicants take a genomics class and his program has a high cost.

Eric asked the panel when might clinical use will happen or become routine.  Johnathan said that technology will happen soon, but he did not know when clinical practice will happen.  Kevin said that the clinical use of personal genomics is happening now and cited the case of the boy from Wisconsin who was helped by NGS based diagnostics.  He said that there is a huge amount of genetic medical education that is needed.  Pillar said that she believes that the clinical context will take some time to work out.  My take on personal genomics and social media is that we are still in the early early days.