A Steadfast Dedication for Improving Therapeutic Options across the Globe: DiaCarta
Headquartered in Richmond, California with an ISO 13485 and CLIA certified facility, DiaCarta develops, manufactures, and markets cancer research and IVD products and performs molecular testing ‘liquid biopsy’ services for precision molecular diagnostics. The company specializes in genomic testing for biomarkers and offers clinical sample testing services in its CLIA-certified lab. DiaCarta also has business operations and clinical service lab in Shanghai and Nanjing, China, respectively. With a mission to provide highly sensitive and advanced technologies that will improve the way molecular diagnostics and translational genomics impact healthcare treatment plans and the well-being of individuals around the world, DiaCarta is changing the landscape of molecular diagnostics.
In Dialogue with Michael J. Powell, PhD., Chief Scientific Officer at DiaCarta:
What led to the inception of the company?
DiaCarta was founded in 2011 with a vision to make a difference in patients’ lives. We wanted to make diagnostic testing better and available for everybody including enabling better disease diagnosis and patient management through providing more sensitive, reliable and rapid molecular tests. DiaCarta was founded to develop technologies because at the time the commercially available technology for oncology and infectious disease diagnosis and management was not ‘state of the art’ and especially the diagnosis and management of cancer, In the past and also currently a ‘tissue biopsy’ methodology is employed that involves the surgical removal of a piece of a cancer patients’ tumor and to preserve in formalin and then fix in wax; so called Formalin-Fixed Paraffin Embedded (FFPE) and then for a pathologist to look at it under a microscope. This is an invasive procedure and often a tumor biopsy is not possible. DiaCarta was founded to develop a new paradigm for molecular testing.
Can you talk about the biotech arena? What is the prevalent market status?
One of the main challenges in the biotech arena is educating the community and bringing them up to speed to modern testing technology. A lot of people are still in the ‘Dark Ages’ with respect to the advancement in the industry. We have to play a significant role to educate the medical community about the novelways we can test cancer or related diseases to help patients in general. Furthermore, open communication and availability of information are the key right now in biotech. There are a lot of people talking about aspects of new molecular tests available and what the doctor really has at his disposal. However, the industry is dominated by big companies who have a lot of money and invest huge amount on marketing, which is a major problem because it affects small companies because they don’t have that kind of marketing muscle but they have the best technology.
Do challenges motivate you? Can you talk about them?
We are very creative and we are also passionate about what we do. So, challenges often completely motivate us. When we have a challenge and we develop technologies to tackle that challenge. Our motto is One Team One Dream. We really want to make a difference by providing the medical technology to everybody. Not just for those who can afford it.
We have developed our suite of molecular diagnostic tests so that they can be run on instrumentation that is already readily available in customers pathology and molecular oncology laboratories. They can utilize our molecular assays on their platform and we have developed very sophisticated chemistry solutions to enable more rapid, sensitive and reliable molecular tests. Our technology allows researchers and clinical molecular pathologists find disease associated genetic variations (mutations) in a large background of normal genetic material (wild-type). To find the ‘Needle in the Haystack’. There is a lot of data available from large scale genomic analysis studies such as The Cancer Genome Atlas (TCGA) initiative that provides deep insight into the genetic variation (mutation) landscape of mutations in various cancers, and we provide a better method for detecting these variations by eliminating the background from the large excess of normal genetic material found in nucleic acid samples isolated from patients tumor’s and blood stream. It’s like you are looking for a needle in a haystack and instead of looking for single pieces in a haystack to find a needle, you just burn the haystack and make a stack of needles- we replicate the needles so that we can detect them easily.
What are the factors that make your brand most innovative and why?
We have an innovative revolutionary technology which requires less DNA also have higher sensitivity and much more reliable results as we reduce background. Additionally, customers can use existing hardware and don’t have to invest in any new hardware; they can use our tests on their existing machines. This is the beauty of our technology. Furthermore, we are driven by the customer. As Steve Jobs said, “You’ve got to start with the customer experience and work back towards the technology, not the other way around”. We started to watch the market needs; we don’t create technology and try to force fit it into the market. Rather we see, what the customer needs and what do they want as we intend to answer that problem.
Discuss the greatest attributes of DiaCarta.
We produce tests that meet the needs of the market for the rapid, highly sensitive detection of genetic variations(mutations). When clinical labs and testing service screen patients for oncogenic ‘driver’ or drug resistance mutations using current testing methodology sometimes the critical genetic variation (mutation) is hidden and not detected because the sensitivity of the technology is not adequate to be able to find the mutation. So there is potential for misdiagnosis due to the low sensitivity of existing technology and the patient who is eligible to be treated may not be treated due to ‘false negative’ result(s) or may also exhibit a ‘false positive’ result due to the presence of a high background signal generated by the large amount of wild-type ‘normal’ genetic material present in the biological sample. However, unlike invasive surgical ‘tissue biopsy’ there is a trend to move to more convenient ‘LiquidBiopsy’ wherein the clinician acquires a patients blood sample and the circulating cell-free tumor DNA is analysed for pathogenic or deleterious mutations that can signal the presence of disease or development of drug resistance. This is a minimally invasive procedure and allows the dynamic monitoring of patients for disease recurrence after therapy or for monitoring for development of drug resistance People get blood tests all the time, you go to the doctor and get a blood sample. We can screen blood for mutations in a dynamic fashion on a monthly basis, thereby following the potential re-occurrence of malignant disease. Right now our ColoScape™ colorectal cancer test blood test is being clinically validate for detection of CRC re-occurrence after surgery or chemotherapy. Therefore, we look at people who have been treated already and they give a blood sample and we monitor their blood to see if the tumor has come back.
Brief us about your new products that will hit the market soon.
We have ColoScape™ test a blood and tissue biopsy test for detection of colon cancer. There are already some FDA approved tests but they are not very sensitive for detection of early stage colorectal cancer i.e. Stage I and below. Furthermore, have also developed a radiation therapy liquid biopsy toxicity assay called RadTox™ which is totally unique in the field and this is set to change the paradigm of radiation/Chemo treatment monitoring for cancer patients. During radiation therapy, the doctor has to gauge the dose of the radiation and it is very difficult to gauge the amount of ‘collateral damage’ to normal cells vs cancer cells in the patient. We have a contract with the NCI (Nation Cancer Institute) to develop this assay as a companion diagnostic for radiation therapy. This may also be applied for immunotherapy as well. Many people can experience serious life-threatening side effects with immunotherapy and it becomes very important to monitor the patients status during treatment to manage these potential side effects more effectively. By using our toxicity monitoring technology to measure the amount of cfDNA released into the bloodstream derived from tumor cell killing (apoptosis) vs healthy cell apoptosis one get a very early indication of therapy effectiveness and the effect of the therapy on normal tissues (toxicity) and thus therapy management is more effective which leads to saving a patient’s life. Which is after all is what precision medicine is all about!
Next-generation sequencing (NGS) is a powerful tool that has seen a fast increase in clinical labs although only a few NGS tests have been approved by the FDA. However, there have been a lot of debate on if variants from NGS sequencing should be confirmed either by Sanger sequencing, the gold standard, or other techniques such as quantitative PCR, or the combination, or other methods.
Eighty five percent of the lung cancer patients are non-small cell lung cancer (NSCLC) patients. Among this population, patients with exon 19 deletion and L858R mutations respond well to the first (such as erlotinib and gefitinib) and second generation (such as afatinib and dacomitinib) of tyrosine kinase inhibitors (TKIs). However, all the respondents develop resistance after 9 to 14-month period and more than 50% of the resistance cases are due to the single point mutation at exon 20, T790M.
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