Vladimir Savanovich, along with his partners, has launched ARNA Genomics US Inc., a company introducing innovative technology and platforms for early cancer detection. The company operates a laboratory in Aliso Viejo, California, and collaborates with a partner laboratory in New Jersey, both equipped to conduct the test and staffed with skilled molecular biologists To date, Vladimir and his partners have invested over $5 million in the project. This funding has been sourced from their personal finances, contributions from Vladimir’s friends, private investors, and the venture fund Exploration Capital, which Vladimir secured through a competitive process.
Novelties and technology
The scientific team discovered unique circulating free tumor DNA (ct-DNA) markers and a pioneering method for detecting such ct-DNA directly from blood plasma without prior extraction. The sample preparation is done in a single tube to maintain the DNA in its most native form for further analysis. This technique enhances the accuracy of diagnostics by allowing for the analysis of individual DNA fragments and their initial quantities per unit volume in the patient’s blood. Subsequently, the team expanded their technological scope by integrating methods to identify cancer-specific proteins and their interactions, which become more pronounced as tumor cells break down. This comprehensive diagnostic approach, known as multi-omics, combines the analysis of both the genome and the proteome. The technology offers exceptionally high specificity and sensitivity in liquid biopsy diagnostics, positioning this test at the forefront of breast cancer diagnostic methods.
Initially, the test was intended for widespread use in diagnosing various types of cancer. However, obtaining FDA approval for such a broad application is exceptionally challenging and expensive, and offers limited useful information to patients and their physicians. Following consultations with external experts, the team shifted its focus to target specific cancers, starting with breast cancer. Utilizing their proprietary technology, a distinctive method for gene search and selection, they analyzed plasma DNA from both healthy individuals and breast cancer patients across major biological subtypes, including Luminal A, Luminal B, HER2/neu, and Triple Negative. This approach facilitated the identification of markers involved in cancer development. The genes and enzymatic activities discovered via this method are protected as part of the company’s know-how and form an important aspect of its intellectual property.
The famous US microbiologist Charles R. Cantor talked about ARNA technology: “ARNA Genomics has unique approach to developing and deploying liquid biopsy tests for early detection of cancers and monitoring response to therapy. Because liquid biopsy tests are non-invasive (usually just a blood test, urine sample, or smear) and inexpensive, they are likely to become widely used as diagnostic tests. This area is extremely competitive, but because ARNA does things differently, it is likely to acquire strong intellectual property and significant market share.”
The latest clinical study showed promising results. Among 80 samples, comprising 44 from healthy individuals and 36 from cancer patients, the result is: – sensitivity 100% (with a confidence interval of 0.99), accurately detecting all cases of confirmed cancer, – specificity 85% (confidence interval 0.99), which implies that it incorrectly labeled 15% of the healthy subjects as diseased, thereby producing false positives.
Liquid biopsy market
Liquid biopsies are a minimally invasive medical test mainly used in oncology. They involve analyzing a patient’s bodily fluid, usually blood, to detect circulating tumor cells (CTCs), tumor DNA fragments or/and proteins associated with cancer. This method offers early cancer detection, monitors treatment response, and identifies cancer recurrence. It’s non-invasive, safer, and easier than traditional tissue biopsies, especially for repeated tests. Liquid biopsies provide real-time genetic information about the tumor, aiding in understanding tumor heterogeneity and in making more informed treatment decisions. While promising, they have limitations like potentially low tumor DNA in early-stage cancers, and ongoing research is focused on enhancing their accuracy. Overall, liquid biopsies are a significant advancement in cancer diagnostics and personalized medicine.
The liquid biopsy market is expanding quickly due to factors like the rising incidence of cancer globally, which increases the need for early detection and monitoring. Technological advancements are enhancing the accuracy and viability of liquid biopsies for cancer management. Their non-invasive nature makes them preferable over traditional biopsies, especially for patients unable to undergo surgical procedures. Liquid biopsies are key in personalized medicine, allowing for monitoring of tumor changes and genetic mutations to customize treatments. The market spans various segments, including equipment and services, and is growing not just in North America and Europe, but also in Asia-Pacific, driven by increasing awareness and healthcare improvements. Research is exploring liquid biopsy applications beyond cancer, broadening its potential. However, challenges like regulatory barriers and the need for standardized, sensitive tests persist. With significant investments and partnerships in the sector, the market is poised for further growth, especially in early detection, treatment monitoring, and recurrence detection, reflecting trends towards personalized, non-invasive healthcare solutions.
Hardware and software
Possessing a strong technological edge is a crucial factor in the biotech industry, yet it’s not the sole element for success. Another key aspect where Vladimir and his partner, George Nikitin, play pivotal roles is in developing a modern hardware and software platform to launch their test in the market. Vladimir envisions an innovative automation and robotics system that will enable quick test deployment in most clinics, with results available by the end of a doctor’s appointment.
Despite the company’s size and the stringent control over expenses, Vladimir Savanovich, with his extensive background in automating scientific and technological processes, collaborates closely with his partner and friend George Nikitin to create unique technologies and systems:
- Full-Cycle Automation and Robotization System: This system, designed to handle the entire test protocol from blood sample to result, features a mechanism for operating four manipulator heads with pipettes. It covers the complete sequence of processes, from opening blood tubes and centrifugation to obtain blood plasma, to handling 96 or 384 wells for reagents and plasma, incubation, and photometric sensor readings. This system aims to nearly eliminate human error and significantly reduce test costs, which is crucial for lower-income regions and countries. With this solution, diagnostic costs are expected to be the lowest in the market, alongside the fastest turnaround times without compromising result quality.
- Proprietary LIMS (Laboratory Management System): Named ARNA Panacea, this software system is developed in Go language using Kubernetes for a microservice architecture and Vue.js for the user interface. It incorporates blockchain technology to validate raw data from instruments transparently and irrefutably during protein and circulating tumor DNA measurement in patient plasma. This method ensures data integrity, proving that test results are accurate and unaltered. Additionally, the system employs deep-learning algorithms to refine the method of categorizing patients as healthy or sick, aiming to prevent overfitting.
These innovative approaches reflect Vladimir and George’s commitment to advancing the biotech field with cutting-edge technology and efficient, reliable diagnostic solutions.
Future plans
ARNA Genomics is targeting entry into the US market. Their goal is to secure FDA approval for their Laboratory Developed Test (LDT) after finalizing their clinical trials in 2024. The company plans to roll out its services initially in New York and Los Angeles. Post these U.S. clinical trials, ARNA Genomics is set to intensify its fundraising activities, aiming to expand further within the US and venture into European and Asian markets.
Under Vladimir’s innovative guidance, the company is focusing on broadening its diagnostic reach to encompass a range of different cancer types. Additionally, they are working towards completing the development of their in-house software platform. Once finalized, the intention is to launch it as a Software as a Service (SaaS) system, catering to various entities involved in clinical trials who require a reliable means to present credible results obtained from their studies.