Precision medicine in concert with innovative and disruptive technologies, is creating a mountain of (big) data, moving into the clinic and finding wider and wider acceptance across hospitals and healthcare networks, based on its promise and potential for enhancing patient care via improved diagnostics and more precise therapeutic targeting. This development that requires the healthcare industry to continually evolve which is nicely reflected in the many events that took place in 2016: The year was marked by lots of activities which included both advancements and setbacks in immunotherapy, the formation of new exciting companies, large investments in population initiatives and commercial companies, many acquisitions that will change the face of the industry, as well as scientific breakthroughs that have found early adopters but still await broader uptake. With various diagnostics companies expanding their menus of genetic tests, we also saw an increased and active presence of the FDA along with an impact on reimbursement.
Many news-worthy announcements made headlines on variety of topics such as advancements and applications of liquid biopsies, the disputed CRISPR gene-editing technology’s first application in humans by a Chinese research team, stem cells significantly improving the outcome of stroke in patients, advancements of interoperability between health systems including Epic and Athena Health committing to the cause, digital healthcare services taking over in the area of health prediction (e.g. IBM’s Watson supercomputer being used in oncology to assist in medical decision-making), using the microbiome to prevent, diagnose, and treat diseases, Veritas Genetics launching the $999 Whole Genome and setting a new standard for genetic testing, or Souza taking over Illumina as the new CEO in July of 2016, focusing on the software side of the company, while Flately joined the board spending his resources on the relevant issue of reimbursement.
We learned about significant investments in larger population studies or initiatives, as demonstrated by the continuous efforts around the Precision Medicine Initiative (PMI, now All of Us), with the NIH funding its biobank to support the PMI Cohort Program on top of an additional direct investment of $55M towards the PMI Cohort Program. Other examples of significant resource investment in the field includes: China embracing precision medicine on a massive scale, the joint coalition brought together by billionaire Patrick Soon-Shiong that includes Amgen, Celgene, GSK, and Blue Cross with the goal to advance combination studies with drugs from multiple pharma companies, and AstraZeneca launching a project to sequence 2 million genomes with the aim to pool genomic and medical data in hunt for rare genetic sequences associated with disease. Furthermore, the Cancer Moonshot was kicked off bringing the private and government sector together, and the Chan Zuckerberg Initiative announced committing $3B to cure diseases by 2100 via building tools that allow bringing scientists and engineers together in large numbers for extended periods of time with the hope of sparking novel ideas leading to revolutionary solutions.
Different diagnostics companies expanded their repertoire of genetic tests, which includes Invitae, Kailos Genetics, Color Genomics, Pathway Genomics, and Illumina, while 23andMe announced it will abandoned plans to develop a next generation sequencing technology. With the vast amount of data being generated, aspects of data sharing and/or regulatory oversight took center-stage: companies like Ambry Genetics and Invitae are making their customer data publicly available either via AmbryShare or ClinVar. Another route of data sharing is demonstrated with the Apple’s Research Kit which now incorporates genetics data via its new 23andMe module for more precise data interpretation. With the increase in new health-related gadgets, apps and tests that have been launched, the FDA is now more active and visible in this space, having issued a draft guidance on the subject of next-generation sequencing-based tests. On the reimbursement side however, we see some progress to date with Medicare and Medicaid bumping up final pricing for certain NGS tests.
2016 saw numerous acquisitions with Peridian DX integrating Tute Genomics to further enable personalized medicine for clinical labs via a fully integrated platform, Sunquest acquiring GeneInsight to enhance precision medicine capabilities, LabCorp taking over Sequenom one of the NIPT leaders, Danaher buying Cepheid, a global molecular diagnostics company that develops, manufactures, and markets molecular systems and tests, and Syngene Intl. acquiring Strand Life Sciences assets and with that the rights to NGS data analytics. On the other hand, we witnessed PacBio announcing the termination of the highly publicized collaboration with Roche Diagnostics for the development and supply of diagnostic products based on the company’s Single Molecule, Real-Time SMART technology.
Given the flurry of activities mentioned above, what better way is there to ring in the New Year then with a conference that brings forward and discusses the highlights of these significant developments that are changing and influencing the practice of precision medicine? Be among the first to hear where the field is moving to, what the next phase in this area will look like, and how it will impact you and your business. More at: http://past.pmwcintl.com/
