Multidimensional, computationally rich approaches represent the next wave of innovation, taking personalized medicine to the next level, while demanding more of practitioners, who in turn demand convenient, informative updates on the ever-changing state of clinical omics,” Clinical OMICs noted in introducing itself to readers with its first issue, dated April 23, 2014. Among significant players taking personalized medicine to the next level have been up-and-coming companies and initiatives that over the past five years have translated their research and clinical insights into commercial success.
Below are six examples of companies that have carved out their own niches in the realms of personalized medicine and its underlying application of omics technologies and clinical genetic insights.
10x Genomics got 2019 off to a flying start at the J.P. Morgan 37th Healthcare Conference in San Francisco. CEO and co-founder Serge Saxonov announced that company revenues more than doubled year-over-year, to $146 million in 2018—from $71 million in 2017. Also in January, it announced a $35 million extension of its Series D financing, bringing total capital raised to $243 million. Meritech Capital Partners led the round, with Fidelity and Wells Fargo participating.
10x Genomics has scaled up operations by launching six new major products, and acquiring two companies. It bought epigenetics company Epinomics in August 2018, and two months later acquired Spatial Transcriptomics, a provider of spatial genomics technology designed to allow RNA sequencing to perform in 2D.
“We are now addressing an emerging area of spatial analysis, which will integrate histology and molecular analysis,” Saxonov told Clinical OMICs. “The key to our success has been rapid non-incremental innovation. Most importantly, this comes from awesome people across many different disciplines working together in multi-disciplinary teams. We work hard to nurture the right culture so that these teams are empowered to innovate, create and move with a sense of urgency.”
Saxonov said 10x Genomics solutions are used by more than 90% of top research institutes worldwide on initiatives like the Human Cell Atlas, the Immunological Genome Project, and the Vertebrate Genomes Project. “A crucial aspect of our culture both internally and externally is deep collaboration. We work together with our customers who are scientists at some of the best research institutes, biotechnology and pharmaceutical companies around the world,” Saxonov said. “We also strive for meaningful partnerships with other companies within the industry—companies like Miltenyi, BioLegend, and Immudex—to bring the best solutions to our global network of customers.”
Veritas, The Genome Company, broke the proverbial $1,000 genome barrier in 2015 by making whole genome sequencing available for $999 to nearly 5000 Personal Genome Project (PGP) participants at Harvard Medical School. The following year, Veritas began offering whole genome sequencing and interpretation widely to consumers at the same price through its myGenome product.
Last year, Veritas went further down on price, with a limited $199 myGenome offer that sold out 1000 kits in less than six hours.
“It proved the intensity of consumer demand and the need to continue to bring down the cost. By doing so, we can increase access, more meaningfully feed research that brings personalized medicine and prevention to the forefront, and allow individuals to take more control of their health,” said Veritas co-founder and CEO Mirza Cifric.
Cifric and George Church, Ph.D., of Harvard and MIT co-founded the company with other researchers at PGP, which Church founded in 2005.
“One of the key needs is to help families avoid the 5% of births with very serious genetic diseases,” Church told Clinical OMICs in 2017. “Other compelling applications include avoiding inherited cancers by preventative surgery, cardiac risk mitigation with drugs and contingent diagnostics and pharmacogenomics.”
Since then, among numerous partnerships, Veritas teamed up with Inova in 2017 to create MyMap, which combines myGenome with Inova’s MediMap pharmacogenomic testing, genetic counseling, research, and clinical resources. In April 2018, it joined with Genomenon to develop a next-generation literature prioritization engine.
Also last year, Veritas rolled out two premium whole genome sequencing products. For $1,499 ($500 for myGenome customers), myGenome Premium offers insights on 400+ genes associated with 20+ highly actionable conditions and 125 genes associated with 200+ carrier conditions. And for $2,999 ($1,999 for myGenome customers), myGenome Diagnostic delivers in-depth diagnostic interpretation of all genes known to be associated with genetic conditions.
“Our world-class clinical team sets us apart,” Cifric said. “As sequencing becomes a commodity, a key differentiator is clinical interpretation. We have one of the best clinical teams in the industry, including more than 50 bioinformaticians, curators, developers, genetic counselors, M.D.s, and Ph.D.s dedicated to delivering the highest quality genomic services and information to consumers and physicians alike.”
“Veritas bet on the genome at a time when the prevailing viewpoint said the marketplace wasn’t ready,” Cifric added. “We felt differently, and that bold gamble has been proven correct.”
Years before “precision medicine” became a popular phrase, Geisinger launched MyCode Community Health Initiative, and in the past five years, its foresight has paid off.
“Geisinger had established MyCode in 2007, anticipating the day when DNA sequencing would be cheap enough that we could begin sequencing the entire exome or genome on our patient population in order to predict and prevent inherited forms of cancer and cardiovascular disease,” David Ledbetter, Ph.D., executive vice president and CSO of Geisinger, told ClinicalOMICs.
MyCode has grown to attract more than 200,000 patient participants, and returned actionable results to more than 1,000 participants and their families—an estimated potential impact on 5,000 total patients—who were found positive for disease-causing genomic variants in potentially life-threatening conditions. These include early onset cancers (breast, ovarian, colon) or early-onset heart attacks and other cardiac events.
Contributing to MyCode’s success, he said, has been the close and trusting relationship between Geisinger and patients in central and northeastern Pennsylvania. Patient participation through focus groups and patient-participants on MyCode’s Ethics Advisory Board help ensure a very high consent/participation rate and positive impact on patient engagement systemwide, Ledbetter added.
Geisinger launched the DiscovEHR partnership with Regeneron Pharmaceuticals in 2014 to sequence DNA of MyCode participants. Regeneron created one of the world’s largest DNA sequencing labs and was seeking a healthcare partner with comprehensive, longitudinal electronic health data, with the expectation that leveraging that data with genomic data would allow identification of new drug targets.
“Our interests, resources, and expertise were therefore perfectly complementary, and so a five-year collaboration was initiated, which has just been renewed for a second five-year period,” Ledbetter said.
From its founding in 2015, Tempus set two ambitious goals: Building the world’s largest library of molecular and clinical data; and an operating system to collect, sort, and analyze that data, improving its accessibility and utility to physicians. To that end, Tempus has launched numerous clinical collaborations aimed at uncovering patterns in genomic data, with the goal of helping cancer specialists predict how their patients will respond to treatment.
“We don’t want to create another data silo. We want to put it back into the hands of our collaborators to improve patient care,” said Ryan Fukushima, Tempus COO.
Over the past year, Tempus has partnered with the American Society of Clinical Oncology to support research sites participating in ASCO’s Targeted Agent and Profiling Utilization (TAPUR) Study, designed to describe the performance of FDA-approved, targeted drugs for advanced cancer with a potentially actionable genomic alteration.
Fukushima said a critical factor in the company’s success has been a willingness of stakeholders—including providers, researchers, and pharma—to partner with Tempus to help make sense of its data and build better datasets for precision medicine.
“The second is multiple technology advancements hitting at the same time, including the proliferation of cloud computing and the ability to store and compute large amounts of data at low cost, machine learning and artificial intelligence applications to clean and analyze data in ways like never before; and a million-fold reduction (2x the pace of Moore’s Law) in the cost of generating genomic data due to improvements in sequencing technology,” Fukushima said.
In 2014, a year after its founding, Guardant Health launched its first of two successful assays for later-stage cancer. Guardant360 has been used since then by more than 6000 oncologists, over 50 biopharmaceutical companies and all 27 National Comprehensive Cancer Network (NCCN) Centers. Guardant launched the second later-stage cancer assay in 2017—GuardantOMNI, a panel measuring 500 genes from ctDNA. Later this year Guardant will roll out LUNAR-1 recurrence monitoring tests for cancer survivors, as well as LUNAR-2 tests for early detection of the disease in asymptomatic individuals.
“We believe that the key to conquering cancer is unprecedented access to its molecular information throughout all stages of the disease, which we intend to enable by a routine blood draw, or liquid biopsy,” said Guardant co-founder and CEO Helmy Eltoukhy. “The challenge with diagnosing and treating cancer is everything today is predicated on needing physical access to the tumor. This requires surgery, scans, etcetera. Instead, if one can provide the same information through blood, we could completely change the paradigm of treating cancer.”
The company’s success reflects its focus on putting patients first, hence its heavy investment in clinical evidence generation. A recent example is Guardant’s February release of positive study results showing Guardant360 matched standard-of-care tissue testing in first-live, advanced non-small cell lung cancer (NSCLC). “We have over 40 Guardant360-based clinical studies that have helped drive nearly 100 peer reviewed publications and nearly 300 scientific abstracts,” Eltoukhy said. “These publications have been in many high-impact journals and have increasingly provided support for use of Guardant360 in the first-line advanced cancer setting, even before tissue, for genotyping applications.”
WuXi NextCODE has grown over four years into a global genomic data and insights company that powers drug and diagnostic development with biopharma and medical center partners. The company also partners with pediatric hospitals to provide clinical exome diagnostic and interpretation services. It took its present form in 2015 when NextCODE Health was acquired by WuXi PharmaTech for $65 million. NextCODE—a spinout of personalized medicine pioneer deCODE Genetics, acquired by Amgen in 2012—was merged with WuXi’s Genome Center to form the company.
“WuXi NextCODE’s success stems from continued innovation building on the legacies of the three companies from which it was formed,” said Jeff Gulcher, CSO and co-founder.
The first is deCODE, which generated whole genome sequence data and detailed medical data on more than 400,000 people in Iceland, and developed the database architecture and tools to manage and analyze these data. The second is WuXi Apptec, which owns the only large CLIA- and CAP-accredited genomics laboratory in China. The third is new subsidiary Genomics Medicine Ireland (GMI). In November, the company joined GMI and The Ireland Strategic Investment Fund in a $400 million initiative intended to position Ireland as a key hub for genomics R&D.
The Irish initiative broadens WuXi NextCODE’s global focus; it bases operations in Shanghai; Cambridge, MA; and Reykjavik, Iceland. Also last year, WuXi NextCODE joined with Google Cloud and AWS to provide genomics services worldwide. WuXi NextCODE technologies include the SeqPlus formalin-fixed, paraffin-embedded (FFPE) sample preparation method, designed to extract DNA fragments of higher molecular weight, producing sequence alignments that cover 98% of the genome, at a depth of 20X. That approaches results obtained with fresh frozen samples at comparable levels of sequencing, with similar numbers of heterozygous and homozygous calls.