Q: ONCE SEQUENCING HAS BEEN VALIDATED AS A CLINICAL SOLUTION VIA TRUSTED WORKFLOWS, AND COINCIDING WITH THE TECHNOLOGICAL DEVELOPMENTS DRIVING COSTS LOWER, WE CAN EXPECT ACCELERATED HUMAN GENOME PROFILING FOR CLINICAL DX. HOW SOON, DO YOU THINK, WILL WE SEE ACCELERATED GROWTH AND WHAT CAN WE EXPECT?
A: We will see accelerated human genome profiling for clinical Dx in 2019 and the coming years as more biomarker-based cancer drugs are gaining approval. Sequencing plays a crucial role in drug-CDx co-development for targeted therapies and immuno-oncology. The continuous reduction in sequencing costs will drive accelerated growth. Additionally, insurance coverage and regulatory approval of sequencing-based genomic profiling tests have paved the way for the efficient review and increased availability of additional cancer profiling products.
Q: TELL US MORE ABOUT YOUR ORGANIZATION/COMPANY. WHAT PATIENT POPULATION ARE YOU SERVING AND WHICH SERVICES ARE YOU SPECIALIZING IN?
A: Predicine has developed an NGS-based RNA+DNA combo liquid biopsy technology to support clinical trials and targeted therapies. We have facilities in the US and China which gives us the unique ability to test specimens from around the world. Specifically, we have established a CLIA/CAP facility in Silicon Valley for supporting clinical trials, a CAP facility in Shanghai, China for clinical trials and patient testing, and a facility in Harbin, China dedicated to patient testing only. Our US site supports biomarker-driven clinical trials, and our China sites cover both clinical trial and clinical testing. We currently work with the top 10 pharma companies to support their global clinical trials.
Q: WHAT MAKES YOUR HEALTHCARE/COMPANY SERVICE UNIQUE?
A: Predicine is a global healthcare molecular insights company. Our founding team comes from Genentech, Roche and Novartis with extensive industry experience and deep domain expertise in biomarker-driven precision drug development. “From Pharma, For Pharma” is the backbone of our business operations. We focus on emerging technology where there is no solution available in the field and aim to build clinically relevant molecular insights in the long run.
3 things make Predicine special:
1. ctDNA+ctRNA liquid biopsy technology innovation. Different from currently available ctDNA technology, Predicine has developed a ctDNA+ctRNA combo liquid biopsy test based on our proprietary GeneRADAR technology that measures ctRNA and ctDNA concurrently in a single test. This technology detects not only genomic variants (SNV, indels, rearrangement, copy number gain/loss) at ctDNA level but also detects ctRNA-based biomarkers (such as splicing variants) at the biological function level. The addition of ctRNA boosts detection sensitivity and specificity for cancer variants that might be missed by ctDNA detection alone.
2. Cross-border operations. We have established an integrated one-stop biomarker platform that offers harmonized assays through our CLIA and CAP facilities in the U.S and China to support global clinical trials. This is particularly helpful for biopharma partners that are running global clinical trials including China because biospecimens import and export in China is nearly impossible.
3. Predicine Network and RWE biomarker database. We are establishing a real-world biomarker landscape database through Predicine’s network of oncologists, cancer hospitals and institutions to support our biopharma partners with trial design and precision enrollment. We launched the Double-Ten Initiative in which we profile matched liquid and tissue biopsy samples in the top 10 most common cancer types with 10,000 samples in each indication. The goal of the project is to build a comprehensive healthcare molecular insight database connecting genotype, phenotype and clinical response data.
Q: WHAT IS YOUR ROLE AT AND WHAT EXCITES YOU ABOUT YOUR WORK?
A: I am the Founder and CEO of Predicine. The inspiration of starting Predicine came from our experience working at Genentech, where biomarker-driven clinical trials and precision medicine were limited by technology and business operations. We wanted to challenge the status quo by innovating technology and business model to solve the pain-points shared by many global biopharma companies.
Predicine was founded to fulfill its grand mission – to empower the global healthcare ecosystem through innovation. Predicine’s name tells its story, precision diagnostics to enable precision medicine. In the last 4 years, we have made significant progress to bridge the gap through innovation in technology (i.e., developed an RNA+DNA combo liquid biopsy test) and innovation in business model (i.e., established an integrated biomarker platform to enable biomarker-clinical trials in US and China). My role is to bring in resources needed to accomplish the mission, including people, strategies, funding and technological ideas.
Working at Predicine has been transforming and inspiring for me. I come to work full of gratitude and promise in the morning and leave office with inspiration and new learnings at night. I am excited to see the immediate impact of our work on patients who benefit from targeted and immuno-oncology therapies because of Predicine. To me, it is a true privilege to work with the best and brightest minds on this cutting-edge technology to address the unmet medical need. Science is joy, and business is chemistry.
Q: HOW WILL GENOME PROFILING CHANGE THE STANDARD-OF-CARE IN THE NEAR AND/OR FAR FUTURE?
A: Cancer is a genetic disease. Genome profiling of cancer has proven its clinical utility in guiding treatment selection, disease monitoring, drug resistance and early detection. Genome profiling is now part of the standard of care practice today and will continue to improve physician ability to drive patient-specific treatments in the near future.
Unlike standard PCR-based single gene test—which looks for a gene-specific genetic alteration—sequencing-based genome profiling doesn’t presuppose knowledge of the cancer’s exact profile by looking at as many genes as you want. At Predicine, we use next-generation sequencing to detect the “alternations of interest” in “many genes of interest” using sophisticated proprietary algorithms and connect the findings to FDA-approved therapies or clinical trials for the specific alterations.
Q: WHAT ARE SOME OF THE MAIN CHALLENGES WE NEED TO OVERCOME TO SEE WIDESPREAD ADOPTION OF WHOLE GENOME PROFILING ACROSS THE CLINIC? HOW CAN THE COMMUNITY COME TOGETHER TO ADVANCE ITS ADOPTION?
A: The adoption of whole genome profiling across the clinic and implementation of personalized medicine permeates all healthcare delivery processes, requiring extensive investment and infrastructure changes.
The main challenges remain in two categories: internal factors from each provider organization such as technology, data management, and clinical interpretation, and external factors including cost, regulation, reimbursement, ethical concerns, health information management, community and government. The interplay of these internal and external issues and the widespread adoption of sequencing may take time to implement across the clinic.
From the financial perspective, whole genome profiling is applicable for tissue biopsy but it is too costly for liquid biopsy when tissue biopsy is not available or not adequate. There is a need to leverage both tissue and liquid biopsies for whole genome and targeted profiling.
Q: WHY SHOULD WE SEQUENCE THE ENTIRE POPULATION, INCLUDING THE HEALTHY ONES?
A: The global healthcare system is under increasing strain because of the rising prevalence of chronic conditions, such as cancers, diabetes, cardiovascular and cerebrovascular diseases which are often associated with genetic alterations, population aging, poor dietary choices, physical inactivity, tobacco use, and other factors. A vast genetic dataset across tens of thousands of individuals has shown to radically improve the researcher’s abilities to make new discoveries about the causes of these diseases and uncover genetic alterations which advances translational research and clinical science.
In the realm of human genetics, large datasets that cover healthy volunteers and patients provide a population-based more complete picture of how an individual’s genetic landscape associates with human health. It is for the same reason that Predicine launched its Double-Ten Initiative to profile matched tumor tissue and liquid biopsy samples from cancer patients, together with healthy donors as baseline, to build a real-world clinically relevant biomarker landscape for precision medicine.
Q: WHEN THINKING ABOUT THE FIELD YOU ARE WORKING IN, WHAT ARE SOME RECENT BREAKTHROUGHS THAT ARE PROPELLING THE FIELD FORWARD AND HOW WILL THEY IMPACT HEALTHCARE?
A: 2 recent breakthroughs that are propelling the field forward:
FDA approval of NGS-based clinical diagnostic tests is a regulatory breakthrough that paves the way for similar NGS-based cancer profiling tests to come to the market quicker.
The recent approval of AstraZeneca and Fibrogen’s Roxadustat first in China, well before the U.S., EU or Japan demonstrates China’s efficient regulatory mechanism to accelerate global clinical trials and its large patient pool.
At Predicine, we partner with biopharma companies to develop NGS-based RNA and DNA sequencing tests – using either liquid or tissue biopsies – with the ultimate goal to accelerate concurrent drug approval in US and China. I envision more FDA approved NGS tests and companion diagnostics in the next few years, which will radically improve global healthcare as a whole.
Q: IS THERE ANYTHING ELSE YOU WOULD LIKE TO SHARE WITH THE PMWC AUDIENCE?
A: I want to share a piece of exciting news regarding a prospective clinical trial that we are sponsoring to validate the clinical utility of Predicine’s liquid biopsy technology in breast cancer. This study is the first prospective study where PredicinePLUS™ panel is used as the sole liquid biopsy test in the trial for molecular profiling and compared to standard imaging and tissue testing with the ultimate goal to match breast cancer patients with approved drugs and novel therapies in clinical trials. More exciting data will be released in 2019.
A recent study from Northwestern University, led by Professor Massimo Cristofanilli, President of International Society of Liquid Biopsy, compared Predicine and Guardant Health’s ctDNA assay in metastatic breast cancer patients. Result was presented at the recent SABCS 2018 Conference, showing similar performance of 73-gene Guardant360™ and 180-gene PredicinePLUS™ for genes shared on both panels. However, PredicinePLUS™ panel, but not Guardant360™, demonstrated a significant correlation with treatment response and overall survival.
To address the diverse needs in clinical genomics, we have developed a biology-oriented portfolio of liquid biopsy NGS panels (ranging from 25-600 genes) for measurement of TMB, DNA damage repair, fusion, and common cancer variants. We offer harmonized assays to support biomarker-driven global clinical trials in US, EU, APAC including China.
At Predicine, we are passionate about empowering the global healthcare ecosystem through innovation, utilizing our technology in RNA+DNA combo liquid biopsy and cross-border business model to advance patient care and clinical drug development. We look forward to more collaboration with biopharma and academia in the new year!