How much would you pay to know your risk of developing cancer? American company Myriad Genetics offers such a ‘fortune-telling’ service for £2000, although the genetic test itself costs less than £200 to carry out. Despite the price tag, many still want a glimpse into their future, including actress Angelina Jolie, who had the test done earlier this year. After discovering that she was at risk of developing breast cancer, she took no chances and had a double mastectomy.
Artwork by Amber Barton
The soothsaying service works on the principle that some cancers are hereditary. Inheritable mutations in the BRCA1 and BRCA2 genes greatly increase a woman’s chance of getting both breast and ovarian cancer. These BRCA genes carry the code for proteins involved in repairing DNA damage. When mutations render these caretaking proteins non-functional, the DNA can become unstable, making mutations that lead to cancer more likely. Thankfully, BRCA mutations are uncommon and scientists can sequence the genome to test for them.
Until this year, however, Myriad has held a tight grip on BRCA testing, having held patents on the genes since the late 1990s after introducing their BRACAnalysis test for breast and ovarian cancer in 1996. This is all due to change, as the Supreme Court of the United States (SCOTUS) made a decision in June that naturally-occurring DNA can no longer be patent eligible.
US law states that inventors who discover something natural should not be able to patent it, as it is not a true invention. Despite Myriad’s claims that its BRACAnalysis test requires human ingenuity, SCOTUS ruled that sequencing genes does not actually make anything new. In fact, every human being carries these genes – it’s just a matter of finding them and examining them for mutations. This ruling makes scientific sense. After all, Darwin never got a patent for his ‘invented’ idea of natural selection! But aside from the end of Myriad’s monopoly, the SCOTUS verdict gives other causes for celebration for scientists and patients across the globe.
Since the 1990s, Myriad has sent letters to several institutions to stop their BRCA research. Although there were initially no lawsuits filed, their actions hinted at ulterior moneymaking motives. But now, new companies can get involved with genetic testing, allowing competition in the market by offering cheaper tests. Ultimately, this will lead to testing being accessible to all sectors of the public, and not just to people like Angelina Jolie, who has a net worth of over £90 million. This is also encouraging news for scientists who can finally study the BRCA genes, free from controversy. The ruling will accelerate research for therapies alongside a myriad of diagnostic and prognostic assays.
But are scientists out of the legal quagmire yet? One snag is that cDNA or complementary DNA (which SCOTUS wrongly calls composite DNA) can still be patented. Made in a laboratory as opposed to isolated from cells, cDNA can be used to test for BRCA mutations, although it is not the only method for sequencing DNA. Claiming that its cDNA patents were breached, Myriad sued Californian company Ambry Genetics, a lab which has been providing the test for £250 in the wake of the ruling. Ambry Genetics, however, denies using cDNA in its BRCA test. There is no doubt that Myriad, which gains 75% of its revenue from its flagship test BRACAnalysis, can’t help but feel a palpable sense of competition. As if competition was Myriad’s only problem, Ambry Genetics and Texan firm Gene by Gene recently launched a countersuit arguing that Myriad still tries to unlawfully monopolise the genetic testing industry, breaking US antitrust laws.
Between the squabbling companies, however, I believe we can look forward to a future of great progress. I have faith that the US justice system, which ended a 16-year-long monopoly, will resolve these controversies, for the good of patients across the globe. When this happens, a commercial form of Darwin’s unpatented natural selection will select for cheap, efficient and most importantly of all, lifesaving service. Watch out, folks, a genetic testing revolution is at hand!
