How does the company do this by using genetic radar technology to achieve early screening of cancer?

Release date: 2017-06-29

Since ancient times, the PK of humans and diseases has never stopped, and medical care has always saved and protected human life. Nowadays, with the rapid development of biotechnology, bioinformatics and big data science are surging, and the “personalized” new generation of medical treatment, Precision Medicine, is on the scene!

On a sunny afternoon, in Silicon Valley's Predicine, Silicon Valley secret agent interviewed Dr. Jia Shidong, a precision medical expert and founder and CEO of Predicine.

The dream of individualized medicine

The clock was reversed for 20 years. In the cold winter day in the north, Jia Shidong, an intern at Harbin Medical University, went to the doctor with the attending doctor. He saw dozens of patients in the morning of the respiratory department. The drugs were basically the same kind of drugs. Jia Shidong was strict. According to the teacher's guidance, symptomatic treatment, but in the subconscious, he felt that the same medicine could not have the same effect on everyone. The experience of that day led to his thinking: Can clinical treatment be treated differently for individual treatment, thus implementing individualized treatment? In this way, the dream of accurate diagnosis and personalized medicine has quietly sprouted in the heart of Jia Shidong. . .

Subsequently, Jia Shidong was admitted to the Chinese Medical Temple - Concord Medical University Ph.D., his research topic is the use of cutting-edge technology of molecular biology at that time, the cloning and sequencing of human papillomavirus genes associated with cervical cancer. After graduating from Ph.D., Jia Shidong went to the Dana-Farber Cancer Institute of Harvard Medical School for postdoctoral research. Here, he first discovered a new cancer drug target p110beta that can be used to treat a variety of cancers. This groundbreaking and important research was published in the world's top academic journal Nature in 2008, and he won the PART Researcher Award from the Dana-Farber Cancer Institute. The cancer drug target p110beta has triggered the development of new p110beta inhibitors by international pharmaceutical companies such as GSK and AstraZeneca, which are now in Phase I/Phase clinical trials worldwide.

In 2010, Dr. Jia Shidong joined the prestigious Novartis Institute for BioMedical Research, Inc. as the laboratory director, researching and developing CDK4/CDK6 inhibitors, which was recently approved by the US FDA for Treatment of advanced or metastatic breast cancer in postmenopausal women.

Subsequently, Dr. Jia Shidong came to Genentech, Calif., a model of the perfect combination of academic and pharmaceutical industry. As Director of the Laboratory and Head of the Tumor Precision Clinical Trial Program, he led and directly promoted the success of the AKT inhibitor drug in a phase II clinical trial of prostate cancer and breast cancer worldwide. Since 2014, Dr. Jia Shidong has also been the editor-in-chief of the Journal of Circulating Biomarkers, an academic journal, showing his strong research in cancer precision medicine and biomarker research!

Let the dream shine into reality

So, what prompted Dr. Jia Shidong to give up the superior working environment of Genentech and create Predicine?

First come to the brain to make up the human genetic material. We know that nucleic acids (DNA and RNA) are human genetic material, DNA forms RNA through transcription process, and RNA forms a functional protein through translation process. Variations in any part of DNA, RNA, and proteins can cause diseases, such as cancer.

Dr. Jia Shidong told us that the successful development of a cancer drug takes an average of 10 years and costs 2.6 billion dollars. During his time at Genentech, he was responsible for leading the Accurate Clinical Trial Program for Prostate Cancer Drugs, and Phase II clinical trials successfully entered Phase III clinical trials. After the great joy of the success of the taste project, he realized more responsibility at the scientific level. Because prostate cancer usually has bone metastases, clinical tissue samples are difficult to sample, and non-invasive liquid biopsy is the best way to achieve accurate treatment of prostate cancer. At present, the mainstream technology of liquid biopsy is to detect circulating tumor DNA (ctDNA) in blood, but clinically requires molecular detection at both the RNA and DNA levels. Since the RNA molecule is a single-stranded structure, stability and detection analysis are difficult. The current detection of circulating tumor RNA (ctRNA) gene mutations in the blood is a technical gap.

Prostate cancer is the most common disease in Europe and the United States and the fastest growing disease in China. The demand for RNA+DNA combined biopsy technology in pharmaceutical companies and clinical patients is extremely urgent. In order to solve this technical problem in the industry, Dr. Jia Shidong came forward after he sought no results in many parties, and determined to focus on RNA+DNA liquid biopsy to achieve technological breakthroughs. In this way, in 2015, Predicine was born in Silicon Valley, California! Dr. Jia Shidong is the founder and CEO. Predicine = Precision Diagnostics & Medicine, or Precision Medicine, which means "precise medicine through precise diagnosis."

China is the world's number one cancer power. Taking lung cancer as an example, Chinese lung cancer patients account for 46% of the total number of lung cancer patients worldwide. At present, the global clinical trials of new cancer drugs in China are “late, slow, and difficult”. Under the trade-off of the global clinical trial situation, the clinical Phase I and Phase II trials are carried out faster abroad, and only enter the China stage if the necessary clinical Phase II or Phase III trials. Due to the limitations of Chinese policy laws and technologies, the number of clinical trial organizations and medical institutions that China can interface with international standards is scarce. In terms of biomarker research, the law stipulates that clinical samples of Chinese patients cannot go abroad, and biomarker testing of all clinical samples must be completed in China. Since biomarkers are the only way to achieve accurate drug development and personalized medicine, biomarker detection has become the rate limit for clinical trials of new drugs in China.

Therefore, in 2016, Dr. Jia Shidong founded the company of Predicine, Huidu Medical, in Shanghai. "Hui" stands for "smart medical care", "Fu" stands for "far crossing the ocean", and "Huidu" also means "huidu sentient beings".

Predicine operates in Silicon Valley and Shanghai, China, to achieve global positioning.

The company's vision is to connect patients and healthcare with the mission of technological innovation to advance the global healthcare system.

Gathering

Birds of a feather flock together. Dr. Jia Shidong, an international leader in precision medicine and liquid biopsy, soon formed a group of like-minded elite "dream team."

Dr. Du Pan, co-founder and chief technology officer of the company, served as assistant professor at Northwestern University, senior computational biologist at Genentech, and chief scientist at Roche, in bioinformatics and liquid biopsy. The second-generation sequencing data analysis has 16 years of deep business accumulation.

The other main players have doctoral degrees from prestigious universities, from the world's top pharmaceutical companies or academic research institutions, and have published more than 300 professional articles. The idea of ​​this team is that “the starting point is the culmination of the industry”!

Technological innovation, clinical application

In the highly competitive high-tech industry, patented technology is the standard for winning. So, what is the “unique skill” of Predicine? That is: Gene RADAR: RNA and DNA single molecule digital reading.

Detection of DNA has been commonplace all along. In fact, the detection of RNA is closer to the function than the detection of DNA, and is more related to clinical diagnosis and treatment. Because of the instability of RNA, it is easy to degrade, and the technical bottleneck is difficult to break through.

In less than a year since its inception, Predicine has successfully developed the first generation of patented RADAR (RNA and DNAsingle molecule digital Reading) based on the combined detection of RNA and DNA in the world. Through the comprehensive scanning and monitoring of thousands of tumor genomic loci in the blood, and the simultaneous detection of trace amounts of tumor circulating RNA (ctRNA) and tumor circulating DNA (ctDNA) in blood, the breakthrough of gene and transcription levels At present, liquid biopsy is limited to the detection limit of tumor circulating DNA, realizing a comprehensive liquid biopsy of tumor in the true sense.

With innovative technology, it is necessary to solve clinical problems. Predicine has redoubled its efforts to introduce three types of liquid biopsy services for full-course health care: Predi-Seq, Predi-Screen, and Predi-Act.

PrediSeq is located in the biomarker clinical study of drug development, used to screen clinical trial patients, efficacy monitoring, drug resistance analysis, and finally developed into a companion diagnosis along with new drugs through clinical trials.

Since the April 2016 AACR (American Association for Cancer Research) annual meeting, Predicine has released “PrediSeq Prostate Cancer”, “PrediSeq Lung Cancer”, “PrediSeq Pan-Cancer”, “PrediSeq Cancer”. Biotherapy solutions for various diseases and drugs such as Immunotherapy and PrediSeq DDR (DNA damage repair). At the AACR Annual Meeting in April 2017, Predicine shared the latest data from Predi-Seq on various cancer research through booths, receptions and 3 posters.

At present, RNA and DNA-based gene radar non-invasive liquid biopsy has been successfully applied in international clinical trials, providing liquid biopsy for clinical trials of various drugs including PD-1, PARP, p110beta, and AR inhibitors in global clinical trials. solution. In response to the application of PrediSeq Cancer Immunotherapy in clinical trials, the famous media in the field of precision diagnosis in the United States published a cover article entitled Tumor Biomarkers Guide Immunotherapy.

PrediScreen is targeted for early screening for cancer in high-risk and normal populations by liquid biopsy. Predicine has accumulated extensive clinical data and experience through research collaborations and commercial projects. Through the statistical modeling of genome and clinical big data and machine learning, the premature screening model PrediScreen was initially established. At present, Predicine and the world's top pharmaceutical companies and medical institutions are continuing to conduct close scientific research cooperation and further accumulate solid scientific data on early cancer screening.

PrediAct is targeted at individualized precision medication guidelines for hospital and clinical applications, enabling real-time detection of tumors, efficacy monitoring, and drug resistance analysis. In September 2016, at the China Clinical Oncology Conference (CSCO), Predicine was the first to launch the “Liquid Biopsy Global Cooperation Alliance”, which will pass the global, multi-ethnic, large population of blood biomarker baselines. Database to achieve early screening and disease monitoring of cancer. At present, Predicine has developed the PrediAct liquid biopsy solution for common tumors in China. It is cooperating with many hospitals in China to serve patients and conduct individualized clinical drug guidance and efficacy monitoring.

Biomarkers, Chinese wisdom

Predicine has established CLIA and CAP standard molecular testing laboratories in Silicon Valley, USA and Shanghai, China, with an area of ​​10,000 and 14,200 square feet respectively, providing the highest level, globally synchronized biomarker clinical testing services for international clinical trials. .

The laboratories on both sides of China and the United States synchronize technology and operations, using blood and tissue samples to provide a global, one-stop and comprehensive biomarker diagnostic, bioinformatics and medical big data solution. For cancer immunotherapy, as well as popular drug targets such as PARP, PD-1/PD-L1 and AR-V7, Predicine is working with a number of international pharmaceutical companies to develop a full range of biomarkers to help in China. - US-Europe-Asia-Australia simultaneous international multi-center drug clinical trials. To this end, GenomeWeb, a well-known media in the field of precision medicine in the United States, interviewed Predicine and published a special interview with PredicineBuilding Out Combined DNA/RNA Liquid Biopsy Business in China. (Predicine has established a DNA/RNA combined liquid biopsy company in China).

Clinical trial patient recruitment, commercial innovation

Dr. Jia Shidong told us that it took an average of 10 years to successfully develop a new cancer drug and cost 2.6 billion dollars. Careful analysis found that many of these 10 years were spent on clinical trials for the slow recruitment of patients. This is the “last mile” of drug approval from R&D to FDA approval, but current clinical trial methods cost the most time and expense.

Ten years ago, the IBM Institute for Business Value released a report stating that "inefficient patient recruitment procedures will increasingly become a daunting barrier for pharmaceutical companies to successfully introduce new products," and called for improved patient recruitment procedures to avoid Waste of investment and elimination of costly time delays are designed to accelerate the introduction of new drugs to the market.

But these issues remain unresolved, and researchers at the University of Sussex Innovation Center have proposed simplified recruitment procedures for patients and doctors through more effective patient empowerment. The healthcare industry must be more proactive in addressing the dynamics between programs and recruitment. Security center resources that organize patient data should provide a large amount of needed data in a timely manner to enable appropriate patient populations to meet clinical trial protocol standards.

To accelerate global clinical trials and reduce drug development costs, Predicine has launched a global, one-stop biomarker and clinical big data analysis system solution that directly drives the quality and speed of clinical trials of new drugs worldwide.

To address the painful and slow pain points of recruiting qualified subjects in targeted new drug clinical trials, Predicine was officially launched at the ASCO (American Association of Clinical Oncology) Clinical Oncology Global Academic Conference held a few weeks ago. The world's first global solution (Predi-Trial) based on liquid biopsy for precision patient recruitment for international multi-center clinical trials. To this end, ASCO professional media Clinical Oncologist Daily gave a cover story to Predicine, entitled Liquid Biopsy to Accelerate Patient Enrollment in Clinical Trials.

For international multi-center large-scale clinical trials in the United States, China, Europe, Australia and other places, Predicine has achieved strategic cooperation with many hospitals and clinical trial institutions in China and Europe. Using Gene Radar Patented Technology (RADAR) and its one-stop biomarker detection and data analysis platform based on blood and tissue, it can accurately screen tumor patients who are most likely to respond to test drugs, thus effectively improving the success rate of drug clinical trials. And progress, reduce the cost of drug research and development, and bring hope to the majority of cancer patients.

Looking to the future

Precision Medicine, a new medical concept and medical model, was first proposed by the famous American genomics scientist Maynard V. Olson in 2011. It is based on personalized medicine and has evolved with the rapid advancement of genome sequencing technology and the cross-application of bioinformatics and big data science. Precision medicine accurately locates the cause of the disease and the target of the treatment, and accurately classifies the different states and processes of a disease, ultimately achieving the purpose of personalized and precise treatment and health management for the disease and specific patients. Compared with traditional medicine, precision medicine has the advantage of “individualized tailoring” and provides full care for human health.

In the new era of precision medicine, Predicine can be described as “coming on the ground and taking off.” Dr. Jia Shidong told us that Predicine's performance has completed a breakthrough from 0 to 1, and recently won a new round of financing. At present, the company is expanding the team in China and the United States to actively promote the application of genetic radar liquid biopsy technology in clinical drug testing, early cancer screening and personalized medicine.

In the end of the interview, Dr. Jia Shidong gave the reader a famous saying by Abraham Lincoln: "The best way to predict your future is to create it."

Yes, this sentence is the best endorsement of the Predicine spirit and the legend of Silicon Valley.

Source: Silicon Valley secret probe (micro signal guigudiyixian)

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