BioFluidica's Liquid Biopsy Technology for Breast Cancer Outperforms Traditional Needle Biopsy

It was bound to happen. Liquid biopsies, the increasingly ubiquitous, non-invasive blood tests that can detect cancer in the blood, often at very early stages, are showing positive results in breast cancer. 

 

Among the most impressive data comes from BioFluidica, a San Diego-based biotech company whose LiquidScan, a next-generation liquid biopsy platform to detect HER2–positive genetic profiles in patients with breast cancer, performed better in a small but significant trial than traditional needle biopsies, according to study results from BioFluidica.

Larger clinical trials are on the way, says BioFluidica CEO Rolf Muller (left). But it now seems virtually inevitable that in the not-too-distant future, cancer clinics nationwide and  worldwide will be deploying liquid biopsies to discover and diagnose breast cancer. 

One of several companies studying liquid biopsy for breast cancer, Biofluidica provides advanced biomarker capture with what they call "unprecedented precision" that is clinically validated in six different cancer types as well as stroke. Muller believes the company’s technology will revolutionize disease and bring improved, non-invasive diagnostics to many people.

Biofluidica's diagnostic platform can precisely capture and isolate disease biomarkers in the blood such as circulating tumor cells (CTC's), and has been clinically validated.

HER2 is the human epidermal growth factor receptor 2, a gene that makes a protein found on the surface of all breast cells.

 

People with HER2–positive breast cancer showed favorable success when using personalized HER2-directed therapy, according to trial results from BioFluidica.

The study demonstrated that current biopsies are missing more than a quarter of patients who may be eligible for HER2-directed therapy. The results suggest that the use of non-invasive liquid biopsy methods can rapidly and accurately identify if patient samples have HER2 status.

 

"We at Biofluidica are very excited after a lot of work to commercialize rare cell and exosome applications important to oncology and fetal medicine,” Muller said in a press statement. "Specifically our recent study on HER2 breast cancer, which opens the door to more detailed tools that may guide targeted therapeutic decisions. "

 

While there are successful tests based on analysis of cell-free DNA, many diseases are not amendable to a cfDNA test. This may be because of the size of the DNA marker, the relative concentration of the marker in the blood, or because of a need to explore more within the biology of the disease in question.

The study was performed by BioFluidica, Neogenomics Laboratories, and Kay Yeung, MD, PhD, from the University of California San Diego Moores Cancer Center and the University of California San Diego Biorepository & Tissue Technology Shared Resource. 

"Our hope with LiquidScan is to be able to facilitate and revolutionize disease research and management. Thanks to its flexibility, LiquidScan can be readily adapted for several applications,” said Muller in a press statement.

"The platform is ideal for those applications where the ability to conduct frequent tests and deliver results quickly where point-of-care testing is critical. I am especially excited that we might be able to find more patients that could be eligible for improved therapy using the high sensitivity LiquidScan Next-Generation Liquid Biopsy platform.”

Breaking News: Liquid Biopsy Company IV Bioholdings Announces Partnership with International AI Company Sonrai Analytics

If a Generation "Y" version of Ferris Bueller walked up to you at Bella Vista in La Jolla and said, "If you don't stop and look around once in a while, you could miss it," he may be an executive at a liquid biopsy company. 

America's cancer diagnostics industry, where simple, non-invasive blood tests are exhibiting unprecedentedly meaningful information about a patient's cancer, is a hot commodity on Wall Street and Main Street. 

But if you don't stop to look around once in a while, you really could miss it.

Take IV BioHoldings (IVBH), a clinical-stage liquid biopsy company based in Newport Beach in Orange County, California. 

This morning, the company announced a meaningful multi-year partnership with Sonrai Analytics, an international artificial intelligence (AI) company that will further accelerate IVBH's efforts to transform the paradigm of precision medicine and save many lives.

Sonrai Analytics' AI applications will bolster IVBH’s analytic capabilities and enable the company to improve on clinical insights for the company’s pipeline of noninvasive blood tests for lung cancer, non-alcoholic fatty liver disease and breast cancer. 

Based in Belfast, Northern Ireland, Sonrai adopts AI approaches to help biotech, CRO and pharma companies efficiently utilize their data. 

In a conversation yesterday with IVBH Founder-CEO Marty Keiser (left), a family man with a refreshing, almost Quixotic take on the work he is doing, he noted that in the digital age, "Abundance beats scarcity every single time. The partnership with Sonrai will leverage AI and enable us to democratize healthcare research and development and accelerate massive value creation for all stakeholders through our novel and highly efficient decentralized partnership model.”

At IVBH, which was built to improve the detection, diagnosis and treatment of cancer and other disease, the work moves at a steady but careful pace that investors love and cancer patients deserve. 

"We are seeing very exciting data emerging from the wet lab at the moment, with evidence of strong clinical efficacy and biological plausibility," he said. "The data is further confirming the novelty of our science and extending our competitive lead in the marketplace."

IVBH expects to begin clinical trials for the Mammogen genTRU-breast diagnostic program in the fourth quarter of 2022. Yes, this year. And the company expects to launch commercially in the first half of 2023. Yes, 2023.

Keiser's goal at Mammogen, which is one of several companies under the IVBH umbrella, is to "complement and enhance existing standards of care and emerging technologies, and get more patients to intervene earlier and reduce unnecessary procedures that are invasive, risky, expensive and stressful."

It seems like a marriage made in liquid biopsy heaven. Sonrai’s cloud-based platform provides full transparency and user-control, and brings the ability to manage structured and unstructured data sources and file types from small CSV files -- a plain text file that contains a list of data - to terabytes of Gigapixel images. 

And of course it also offers AI, machine learning and deep learning methods to extract maximum value from modern precision medicine digital approaches.

“From the very first meeting, it was evident that IVBH was approaching everything in a completely novel way,” Sonrai Founder-CEO Darragh McArt, PhD, said in a press statement. 

Over the last year, said Keiser, IVBH transitioned its time and resources institutionalizing the people, partners and infrastructure required to accelerate its diagnostic solutions to market with speed, efficiency, and a rigorous approach to risk mitigation

“The collaboration with Sonrai closes the loop for us," Keiser said, "providing IVBH with the dedicated data science, engineering and regulatory expertise — and the AI-powered solutions required to optimize the IVBH platform — from R&D through commercialization."