The battle against cancer has been fought for years, and healthcare leaders have continuously tried to come up with new and reliable solutions. Innovative technologies are constantly being developed and improved upon to find feasible ways to detect and treat cancer, including at its earliest stage. Two pioneers in the fight against cancer are Co-Founders and Co-Chief Executive Officers of Guardant Health, Helmy Eltoukhy and AmirAli Talasaz.
Helmy and AmirAli are both serial entrepreneurs in the biotech field and have known each other for about two decades, even working in the same lab in their graduate school at Stanford. They shared the belief that applying ultra-high-scale DNA sequencing to the clinical markets could fundamentally improve the trajectory of patients’ healthcare journeys. They co-founded Guardant Health in 2012.
The dynamic duo of Helmy and AmirAli believes that the key to conquering cancer is to expand efforts to detect the cancers most likely to be cured through early intervention and access to their molecular information throughout all stages of the disease.
The Inception Overview
Cancer being a disease of the genome made it an area where DNA sequencing could make a significant impact if cancer could be found early enough and tracked in real-time through a simple blood-test. This idea became Guardant Ò Health, and its first product, Guardant360 , was launched in 2014. One challenge Helmy and AmirAli have had to overcome is making this new technology, liquid biopsy, accepted in the industry given that tissue biopsy had long been the standard of care. At Guardant Health, their now widely used liquid biopsy tests aim to transform cancer care management across all stages of the disease.
Their Guardant360 CDx test is the first FDA-approved comprehensive liquid biopsy for patients with advanced cancer, and now the company sets its sights on potentially bringing to market the first FDA-approved blood test for cancer screening with the potential to increase the cancer screening.
Since founding the company, Helmy and AmirAli have scaled the company to almost 1,500 employees and launched multiple commercially available products across the cancer care continuum.
The Mission and Vision
Helmy states that the mission of Guardant Health is to conquer cancer with data. Since day one, their vision has been to develop a simple blood test that screens for cancer at its earliest and most treatable stage. To get there, the company has taken a beachhead strategy starting first where the greatest unmet medical need exists – advanced cancer – and where the DNA shed from a tumor into the blood is easier to detect.
Helmy says, “Our company’s blood tests for cancer profiling and monitoring are easier, faster, and less invasive than traditional tissue biopsy-based approaches. Our tests enable physicians to stay one step ahead of a patient’s cancer at all stages of the disease and help identify the latest breakthrough treatments, which are increasingly targeted to the molecular makeup of the tumor and much better tolerated than traditional ‘one size fits all’ chemotherapy.”
AmirAli expresses that they are closer than ever to achieving the goal of providing a simple blood test that screens for cancer at the very earliest stage, among average risk, asymptomatic people.
“We are excited with our progress in our historic ECLIPSE trial with over 10,000 participants, which is evaluating the performance of our blood test to detect the earliest signs of colorectal cancer, and if successful, will support our submission to the FDA. The promise of blood-based cancer screening is quickly becoming a reality, and we see a brighter future for humanity by improving population health and reducing the harms of cancer,” says AmirAli.
A Soaring Impact on Biotechnology
From a technology application standpoint, the company’s significant impact was unlocking the data generated from next-generation sequencing with minimal loss, that is, identifying just a few molecules of mutated tumor DNA from an entire tube of blood or what is known as “a needle in a haystack” problem. Using the collective expertise of Helmy and AmirAli, they solved two challenges to liquid biopsy that were previously unsolved – sensitivity and specificity.
With sensitivity, many technologies for sequencing in the market were losing 95% of DNA before getting to the sequencer. Guardant Health developed new chemistry that successfully converted nearly 90% of the DNA in a tube of blood, i.e., “the haystack”, to search for potentially a single mutated tumor NDA, i.e., “a needle”.
The other problem was that sequencing technologies had a high error rate of 1 in 100, masking with deep signals and noise. The company’s technology lowered the error rate by a thousand-fold. So now, it sees a 1 in 3 million error rate instead of 1 in 100, or in 1000, like other technologies.
Guardant Health continues to update its technology and believes it is the highest performance technology on the market today.
The Significance of Technology
The science of liquid biopsy has been around since the 1950s. Advancements in the last decade have been the tipping point. There’s been a confluence of different genomic technologies, extraction methodologies, and highpowered bioinformatic tools. The affordability of applying next-generation sequencing to routine testing has enabled Guardant Health to get much more sensitive and specific in seeing the trace fragments of either DNA or proteins contained within a tube of blood.
Until the company launched Guardant360 in 2014, off-the shelf DNA sequencing technologies were not only unaffordable but not sensitive enough to see these trace fragments in blood. Now their FDA-approved Guardant360 CDx provides doctors and their patients guideline-complete genomic results with a turnaround time of seven days.
Setting Goals for the Long Run
Guardant Health focuses on what will have the greatest impact on the most patients. AmirAli mentions that too many families are losing loved ones every day to cancer, a disease that remains the second leading cause of death. AmirAli says, “At Guardant Health, our calling is to guard the quality of human life from a debilitating disease and offer patients more time. There are a lot of opportunities to offer value to cancer patients, particularly around increasing cancer screening rates across cancer types and populations by bringing to market a simple blood test for screening that is FDA approved and widely adopted. Even with our test for complete genomic testing in patients with advanced cancer, which informs potentially life-changing treatment, these testing rates remain tragically low. We cannot consider innovation alone success; we must continue to increase adoption of the innovation to truly make an impact on human health.”
Guardant Health’s informatics platform is a machine learning platform, so the more data it gets, the better. “As we continue to test more and more patients with cancer, at all stages, we continue to exponentially increase our knowledge about the disease. This not only fuels profound innovations in the detection and monitoring of cancer, but in treatments that may one day fight the disease before it is even born. Cancer does not sleep, and neither will we until we’ve accomplished our mission of conquering cancer with data,” concludes Helmy.
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