DiaCarta and Pangaea Biotech Join Forces to Launch Non-Invasive Tests to Detect Genetic Mutations in Blood from Cancer Patients

DiaCarta and Pangaea Biotech S.L have signed a long term agreement to launch in the U.S.A and China a non-invasive test to detect genetic material in blood of cancer patients, a technique known as ‘liquid biopsy’. The test, developed by Pangaea, allows oncologists to personalize treatment, monitor response in real time and switch therapies if necessary. DiaCarta is a recognized leader in translational genomics and personalized diagnostics with proven experience in development and commercialization of molecular diagnostic tools. The company’s proprietary QClamp® XNA-PCR technology has resulted in a suite of gene mutation detection kits with detection sensitivity superior to ddPCR. QuantiVirusTM HPV cervical cancer and DigiPlexTM genotyping tests are the products powered by SuperbDNATM and multiplex bar-coding technology platforms, respectively. DiaCarta OptiSeqTM provides an ultra high sensitivity next-generation sequencing (NGS) platform for cancer genome profiling from difficult samples including patient whole blood. Pangaea is a reference provider of molecular diagnostics services and in vitro/in vivo testing and a leader in development of non-invasive diagnostic assays. Both Pangaea and DiaCarta pursue active R+D Molecular Diagnostics programs and Liquid Biopsy Program is one of their main strategic assets on both qPCR and NGS platforms.

Under the terms of the agreement, DiaCarta will commercialize in the U.S.A and China Pangaea’s assays to detect EGFR, KRAS and BRAF gene mutations in blood of cancer patients. The tests can be used in a number of tumor types such as lung, colon, pancreatic and breast cancer as well as melanoma. In addition to making the test directly available to cancer patients through healthcare providers, both companies have planned to provide genetic testing and NGS services powered by DiaCarta OptiSeqTM to pharmaceutical companies with novel targeted therapies in clinical trials in Europe, China and the U.S.A., taking advantages of DiaCarta’s CLIA and Independent Clinical Service labs in US and China, respectively.

For oncologists, having an accurate genetic diagnosis is essential to be able to select the right treatment for each cancer patient, since alterations in specific genes are highly predictive of response or resistance to targeted drugs. To identify these alterations, Pangaea analyzes blood from cancer patients to obtain a comprehensive genetic profile and provide doctors with valuable information they can use to tailor treatment to each patient.

Testing in tumor tissue remains the recommended method to detect oncogenic mutations. However, advances in biopsy techniques now allow for ever-smaller samples to be taken, meaning tissue is often exhausted after the initial diagnosis and serial analyses cannot be performed. In tumors such as advanced non-small-cell lung cancer (NSCLC), normally diagnosed at an advanced stage, some 25% of patients do not even have sufficient biopsied tissue to perform initial diagnostic analyses. Therefore there is a clear need to be able to analyze tumoral genetic material in alternative biosources such as blood.

According to Dr. Rafael Rosell, Chief Scientific Officer, Chairman and Co-Founder of Pangaea, "Great advances have been made in the treatment of lung cancer in recent years, but there are still a lot of unanswered questions. To start finding the answers, we need new clinical trials with novel diagnostic assays that can start to improve the outlook for cancer patients.” Dr. Rosell believes “it is becoming increasingly clear that we need to find alternatives to traditional tissue biopsies to perform vital genetic analyses. It’s also of paramount importance to be able to detect resistance to therapy as soon as it occurs in our patients. A clear advantage of these non-invasive tests is that blood samples can be taken repeatedly, allowing us to monitor disease progression in real time, detect the appearance or disappearance of clinically relevant mutations and switch treatment when necessary.”

According to Javier Rivela, CEO of Pangaea Biotech, “This agreement with DiaCarta is strategic for us since it allows us to place all our capabilities in the fields of molecular diagnostics, clinical trials and precision oncology at the disposal of patients.”

“Teaming up with Pangaea in Spain, Europe, together with our CLIA certified lab in Bay Area and Independent Clinical Service Lab in Nanjing, China, we are well positioned to serve to pharmaceutical companies with novel targeted therapies in clinical trials globally. Further, our QClamp® on NGS, the OptiSeqTM platform can implement mutant DNA target enrichment to detect very low copy mutant numbers that are not possible by conventional NGS protocols.” said Aiguo Zhang, Ph.D., Founder, President and CEO of DiaCarta. “With these platforms and our expertise in IVD development and commercialization, we are pleased and excited to work with one of the world leading experts in lung cancer Dr. Rafael Rosell and his team at Pangaea.”

Cancer is one of the leading causes of morbidity and mortality worldwide, with approximately 14 million new cases and 8.2 million cancer related deaths recorded in 2012. The number of new cases is expected to rise by about 70% over the next two decades. Targeted drugs which are highly effective against the genetic alterations that drive tumor growth have been developed for certain tumor types. However, cancerous cells quickly develop mechanisms of resistance to these therapies and many patients relapse. Therefore, the concept of personalized medicine is a high priority for the design of new clinical trials with next generation therapies.

About DiaCarta
DiaCarta is a translational genomics and personalized diagnostics company headquartered in Richmond, California with business and clinical operations in Shanghai and Nanjing, China, respectively. We are dedicated to the science of rapid and highly sensitive detection technologies and diagnostic solutions for healthcare that positively impact treatment plans and improve the well-being of individuals around the world. QClamp®, a revolutionary new way to screen for tumor oncogenic driver and resistance mutations in tumor DNA derived from cancer patients, utilizes a sequence-specific xeno-nucleic acid (XNA) clamp that suppresses PCR amplification on wild-type DNA template and allows selective amplification of only mutant template with detection sensitivity below 0.1% for a variety of samples including FFPE tissue, liquid biopsy and traditionally challenging cytology specimens. The QClamp® XNA-PCR technology has also been applied for mutant DNA target enrichment on our OptiSeqTM next-generation sequencing platform. To learn more, visit www.diacarta.com.

About Pangaea Biotech
Pangaea Biotech S.L is a biotechnology company led by world-renowned oncologist Dr Rafael Rosell. Founded in 2007, Pangaea has grown rapidly to become a reference laboratory in its field and has established client relationships with some of the largest global pharmaceutical, diagnostics and biotech companies. Pangaea has three main areas of activity: development of diagnostic tools and services - with a special focus on Liquid Biopsy - development of new anti-cancer drugs, and patient care provided by the Dr Rosell Oncology Institute (IOR) located in Quirón Dexeus University Hospital, Barcelona, Sagrat Cor University Hospital, Barcelona, and Hospital General de Cataluyna, Sant Cugat dels Valles. Both Pangaea and IOR are highly experienced in the field of clinical trials and offer a dedicated Clinical Trials Unit and comprehensive molecular diagnostics and pathology testing services.

About Dr Rafael Rosell
The Pangaea team is led by Dr Rafael Rosell, MD, PhD. Dr Rosell is the founder and former President of the Spanish Lung Cancer Group; President and Scientific Director of Pangaea Biotech S.L; Chief Medical Officer and President of the Dr Rosell Oncology Institute; Director of the Cancer Biology and Precision Medicine Program, Catalan Institute of Oncology (ICO). Dr Rosell’s contributions to translational medical oncology, with particular emphasis on the field of non-small-cell lung cancer with EGFR mutations, have earned him international recognition: in 2013 he was recognized by The Lancet as the highest authority in lung cancer in Europe. He has received numerous awards in recognition of his tireless investigations into the causes and treatment of cancer.