Curing cancer may prove more difficult than the "moon shot" referenced during the State of the Union. Is the cure for cancer realistic or rhetoric? "Is it realistic? In a word no." said Dr. Otis Brawley, the chief medical officer of the American Cancer Society. "In my world, 'cure' is a four letter word, but we are going to cure some people."
While cure may remain out of reach for quite some time, survival rate is a different story. In 2015 an estimated 1.66 million new cancer cases were diagnosed in the United States (up from 1.44 million in 2008). The key to improving outcomes is early detection per the American Cancer Society. As an example for all types of ovarian cancer, the 5-year survival rate is 45%. If found in stage 1 (before spread outside the ovary) survival rates improve to 92%. Unfortunately only 15% of all ovarian cancers are found at this early stage. Early diagnosis is the key to improving outcomes and that is the mission of Grail.
Liquid Biopsy
circulating tumor DNA "ctDNA" represents small pieces of cancer DNA shed from a tumor and found in the blood stream. These somatic mutations have led to a new generation of cancer biomarkers. Sequencing technology is now advanced enough to identify these biomarkers at a reasonable cost. As sequencing depth improves smaller pieces of ctDNA can be detected cost-effectively. And small is good as it correlates to tumor growth.
Grail: Illumina to validate cost effectiveness
Illumina (ILMN) has formed Grail with the aim of "massively decreasing cancer mortality by detecting the disease at a curable stage".. Bill Gates, Jeff Bezos, Arch Ventures and Sutter Hill participated in the $100 million Series A financing. Illumina has also transferred two years of internal research into ctDNA biomarkers to kickstart this venture.
The Healthcare Spending Challenge
The significance of Grail is better understood in the context of the current healthcare climate.
- Societally we are trying to reduce the portion of GDP spent on healthcare.
- New diagnostic tests must prove cost effectiveness before insurance providers will cover and reimburse.
- The process of proving cost effectiveness requires years of clinical data from large cohorts. The cost of this effort is likely going to approach $1 billion, requiring clinical trials involving perhaps 30,000 people.
- Most of the science behind Liquid Biopsy is naturally occurring and well known, making it questionable for patent protection.
- This blood test will need to be priced under $1,000 and perhaps as low as $500 in the US to address the general population.
Summary
The ability to detect cancer by finding shed DNA with a blood test is largely accepted already. Improving sensitivity and specificity will occur with the passage of time as sequencing technology and biomarker research progresses. The biggest leap is to prove cost-effectiveness. This will likely succeed by documenting a progressively earlier diagnosis through repeat testing. Assume Grail were to show the average stage at diagnosis is 3.5 in the first year. If that were to improve to an average of 3.0 and 2.5 in the second and third year respectively, the data would be compelling. The need to repetitively sceen for cancer is what drives detection earlier. That need is also what drives the size of the available market which could exceed $100 billion.
The next 3 years will be exciting with the dozens of companies utilizing liquid biopsies for treatment monitoring, recurrence and personalized clinical trials. But the holy grail is early detection and that quest could be achieved by 2019.