The Miracles Behind Genetic Testing

In the mid-1970’s Frederick Sanger, a British born biochemist and two-time recipient of the Nobel Peace Prize, developed techniques to sequence Deoxyribonucleic acid – better known as DNA. Sanger’s work opened the door to that which may be the biggest boon to our current economy – and to our sheer survival. According to information provide by the National Institutes of Health:

In February 2001, the Human Genome Project (HGP) published its results to that date: a 90 percent complete sequence of all three billion base pairs in the human genome. (The HGP consortium published its data in the February 15, 2001, issue of the journalNature.

The project had its ideological origins in the mid-1980s, but its intellectual roots stretch back further. Alfred Sturtevant created the first Drosophilagene map in 1911.

The crucial first step in molecular genome analysis, and in much of the molecular biological research of the last half-century, was the discovery of the double helical structure of the DNA molecule in 1953 by Francis Crick and James Watson. The two researchers shared the 1962 Nobel Prize (along with Maurice Wilkins) in the category of “physiology or medicine.”

In the mid-1970s, Frederick Sanger developed techniques to sequence DNA, for which he received his second Nobel Prize in chemistry in 1980. (His first, in 1958, was for studies of protein structure). With the automation of DNA sequencing in the 1980s, the idea of analyzing the entire human genome was first proposed by a few academic biologists.

The United States Department of Energy, seeking data on protecting the genome from the mutagenic (gene-mutating) effects of radiation, became involved in 1986, and established an early genome project in 1987.

In 1988, Congress funded both the NIH and the DOE to embark on further exploration of this concept, and the two government agencies formalized an agreement by signing a Memorandum of Understanding to “coordinate research and technical activities related to the human genome.”

Source: National Human Genome Research Institute

Presently, work in the field of genetics research is quite expansive. According to an article published in PRNewswire on August 18, 2011, the genetics testing market is “likely to see a rate of growth of around 26% during [the years between] 2012-2015.” As the article states:

With the significant increase in the number of available tests, the genetic testing market is witnessing a strong growth pattern. According to our latest report, “Global Genetic Testing Market Analysis”, the global genetic testing sector was worth around US$ 1.5 Billion in 2010 that corresponds to a share of approximately 15% in the total molecular diagnostics market. The market is further likely to grow at the rate of around 26% during 2012-2015 to reach around US$ 4 Billion. Factors contributing to this growth include increasing demand of newborn screening, high incidences of Alzheimer disease, breast cancer, colorectal cancer, diabetes etc, and research innovations.

Source: Global Genetic Testing Market Analysis

It is the “research innovations” that may, in fact, save my wife’s life. As I mentioned in a previous article, my wife was diagnosed with breast cancer at the end of August, 2012. Though the diagnosis was bad enough, we later learned that she has the BRCA2 gene mutation which puts her at higher risk of breast and ovarian cancer. The bright side, however, (if there is such a thing as a bright side when it comes to cancer) is that now, having the information available, she can take steps to mitigate her risks.

The company that determined that my wife has the BRCA2 gene mutation is Myriad Genetics (MYGN). Myriad introduced its BRACAnalysis in the mid 1990s and, currently, it is the dominant player in predictive medical analysis of breast and ovarian cancers. The company has a portfolio of eight patents, but its revenue is heavily dependent upon its BRACAnalysis, which has had its patents challenged.

To date, the jury is still out as to whether or not Myriad will have its patents upheld. If the diagnostic testing procedures used in Myriad’s BRACAnalysis are deemed to be unpatentable, Myriad’s business model could be seriously impaired. A negative outcome for Myriad could also be bad news for patients, given that many investors and R&D driven businesses will not want to make further investments into diagnostic testing research. There are some, however, who believe that Myriad’s dominance in the field will not be impaired, regardless of the outcome of its patent case.

Myriad’s Long-Term Implications: Watching the Watchers. Looking ahead, it appears increasingly unlikely that Myriad’s denouement, when it finally arrives in 2013 or 2014, will produce a significant effect one way or the other on either Myriad or the personalized medicine industry. We think this is likely to be true regardless of the litigation’s substantive outcome.

For Myriad, win or lose in court, its challenged patents will expire by the end of 2015. But the company’s additional patents (the litigation involves only a small minority of Myriad’s overall BRCA portfolio), its decades of experience as the sole provider of clinical BRCA diagnostic testing and its proprietary database of BRCA mutation information should allow Myriad to comfortably maintain its advantage in the marketplace against would-be direct competitors of clinical BRCA diagnostic testing.

Source: Myriad Gene Patent Litigation

Personally, I believe that Myriad is a company that should be taken very seriously – if only for the value added services it brings to market. Knowledge is power and, in my wife’s case, knowing that she has the BRCA2 gene is very powerful information to have. Having such knowledge (though depressing) offers one the opportunity to tailor her (or his) treatment options so that they will have the best chances at survival.

Unfortunately, however, there are many insurance companies that will not pay for BRCA testing, and the tests are a rather expensive proposition for those who wish to pay for them out-of-pocket. In my humble opinion, though, the tests are truly worth much more than their costs, and insurance companies would be wise to incorporate such testing into their cancer treatment coverage options. Doing so would not only be a value added service that insurers could provide to their clients, the tests could actually reduce overall costs of cancer treatments by reducing the number of redundant surgeries that need to be performed if and when the cancer returns. Had my wife known that she was afflicted with the BRCA2 gene mutation prior to her initial surgery, she would have opted for a different surgical procedure (rather than the lumpectomy that was originally performed). In short, having the information in advance would have spared her an additional breast cancer surgery – and it would have certainly spared her insurer the additional costs.

At the present time, I do not own shares of Myriad’s stock, but I fully expect that, at some point in the near future, I will make an investment in the company. Besides being a potentially good investment opportunity, investing in companies such as Myriad gives me a certain piece of mind in knowing that I am investing in a company that provides wonderful social benefits as well.

Finally, another reason to invest in Myriad is that the company may very well be a takeover target for some of the big pharmaceutical companies out there that may be looking to diversify their portfolios. In 1999 Myriad spun off the pharmaceutical part of its business, which came to be known as Myrexis. The company eventually went bust when, in November 2012, the Board of Directors announced that they intended to put the company into liquidation, subject to the approval of shareholders. Thus, a marriage between big pharma and Myriad’s diagnostic business would seem to be a very good marriage in the making.

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