Phase Scientific: Revolutionizing In Vitro Diagnostics with Proprietary Sample Preparation Technology for Multi-Fold Enhancement in Purification Precision

To improve the accuracy of in vitro diagnostics (IVD), many companies have chosen to focus on the testing process, whereas PHASE Scientific is one of the few companies that has chosen to make breakthroughs in the fundamental and critical step of “sample preparation.”

Zhao Yantao, founder of PHASE Scientific, has been deeply engaged in the IVD industry for many years. He previously served as a project manager at a U.S. biotechnology company, where he led his team to develop the world’s first FDA-cleared innovative technology and product for drug testing using saliva samples.

Dr. Yan Tao Zhao, Founder of PHASE Scientific

Passionate about science since childhood, Zhao Yantao describes his original aspiration as a dream to contribute to the cause of human health. As he delved deeper into the in vitro diagnostics (IVD) field, he became increasingly aware of a critical issue demanding urgent resolution: how to enhance the precision of diagnostic testing?

While pursuing his Ph.D. in Bioengineering at the University of California, Los Angeles (UCLA), Yantao Zhao independently developed a breakthrough patented technology for sample preparation. This technology enables the concentration and purification of test samples even when the initial sample concentration is low, significantly increasing the concentration of target molecules and thereby facilitating their detection.

This proprietary technology can also reduce the concentration process from hours to minutes and seamlessly integrate with any detection tools, including simple point-of-care rapid tests and complex laboratory assays, thereby enhancing their sensitivity and accuracy.

While technical expertise and experience are undoubtedly essential prerequisites for entrepreneurship, startups face a more immediate and practical challenge: how to secure initial funding for their projects?

At the time, Zhao Yantao was pursuing his Ph.D. at the University of California. After conceiving the idea of starting a business, he promptly applied for startup funding from the U.S. government, but his application was rejected due to deficiencies in his project proposal. “There is an advantage to the U.S. government’s startup support system,” Zhao told VCBeat. “With each unsuccessful application, the government specifies which criteria were not met, allowing us to make targeted improvements.”

Drawing lessons from repeated failures, he ultimately submitted a “response” that satisfied the U.S. government. Zhao Yantao applied for U.S. startup grants six times before succeeding on his seventh attempt, securing the first startup grant supported by the U.S. government. He subsequently secured five additional startup grants, continuously refining the research and development of core technologies. In 2014, PHASE Scientific was established in the United States, accumulating a total of $3 million in startup funding from the U.S. government and the Bill & Melinda Gates Foundation.

TuoXi^®Schematic Diagram of Dental Caries Risk Test Kit

After two years of R&D, leveraging the proprietary sample preparation technology independently developed by Yan Tao Zhao, PHASE Scientific has launched its first rapid testing product—TuoXi, a rapid test kit for assessing caries risk.^®Zhao Yantao explained, “In fact, dental caries are caused by specific oral microbiota. By detecting the concentration of relevant microbial communities in the oral cavity, we can accurately assess a user’s risk of developing cavities.” Anyone can simply use Tuoxi^®By detecting the presence of cariogenic bacteria in the oral cavity, one can assess the risk of dental caries within twenty minutes and take corresponding preventive measures.

PHASE Scientific’s sample preparation technology can process a wide variety of sample types, such as saliva, blood, and urine, concentrating biological markers—including viruses, bacteria, proteins, nucleic acids, and inorganic substances—by 10- to 100-fold, thereby significantly enhancing detection sensitivity.

“I had always assumed that our sample preparation technology had no place in the field of molecular diagnostics, since PCR itself amplifies specific DNA fragments by millions of fold,” said Zhao Yantao. “It was not until I returned to China in 2017 and engaged in discussions with experts in the in vitro diagnostics (IVD) sector that I gradually realized our sample preparation technology also held great promise for nucleic acid extraction.”

In 2017, Zhao Yantao returned to Hong Kong, China, and established Phase Scientific International Limited. To further strengthen its development in the domestic market, the company established a Suzhou branch in 2018.

In traditional molecular diagnostics, nucleic acid extraction has relied on solid-phase magnetic bead and column-based methods, which have remained the industry gold standard for decades without being disrupted. However, insufficient purity in front-end sample processing means that only impure nucleic acid samples are available for downstream PCR amplification, leading to unsatisfactory results in subsequent detection. Zhao Yantao jokingly refers to this phenomenon as “Garbage in, Garbage out.”

Sample preparation has long been a core competency of PHASE Scientific. Recognizing the demand for sample preparation in molecular diagnostics, Zhao Yantao’s team developed a dual-phase nucleic acid extraction method called “PHASIFY,” for which a patent application has been filed. Zhao Yantao shared an anecdote: “While conversing with a liquid biopsy expert in the United States, I informed him that we had developed a technology capable of disrupting traditional nucleic acid sample extraction methods. He was highly skeptical, noting that over the past decade, countless company founders had claimed their technologies could challenge the gold standard for nucleic acid extraction, but without exception, all had failed.”

Zhao Yantao asked, “What percentage of the purity achieved by traditional purification methods must PHASE Scientific attain to be considered a ‘successful challenge’?” The answer was: more than 20%. Zhao Yantao then conducted a comparative experiment, dividing the same blood sample into two equal aliquots. One aliquot was processed using the gold-standard extraction method, while the other was processed using the PHASIFY product. The results showed that the nucleic acid purity obtained with the PHASIFY product was several times higher than that achieved by the traditional method.

PHASE Scientific's Two-Phase Nucleic Acid Extraction: PHASIFY^TM

How Does the Dual-Phase Nucleic Acid Extraction Method “PHASIFY” Achieve Purification Precision Several Times Higher? Zhao Yantao Briefly Explained the Principles Behind This Technology: “We add PHASIFY chemical reagents to the sample, transforming it into a state resembling ‘oil’ and ‘water.’ When mixed, the solution becomes a milky, opaque emulsion containing countless microscopic ‘oil’ and ‘water’ droplets. Due to specific chemical, biological, and physical properties of the target nucleic acids, they selectively accumulate within one type of droplet, thereby enabling their separation and purification.”

PHASE Scientific's PHASIFY^TMThis technology can be applied to various liquid biopsy tests, including early cancer screening and non-invasive prenatal testing. Currently, research institutions and the industry are committed to promoting the use of liquid biopsy for early cancer screening. However, due to the extremely low concentration of early tumor gene fragments in the blood, which makes them difficult to detect, the effectiveness of such tests has been limited. PHASE Scientific aims to leverage its proprietary core technologies to improve the sensitivity and accuracy of existing liquid biopsies, thereby achieving a breakthrough in early tumor screening.

It is reported that Phase Scientific is applying for a Class I medical device registration certificate for this product, with approval expected in 2020. The company has completed its initial round of financing and has launched a new funding round, aiming to raise between $10 million and $15 million. The proceeds will be primarily used for the development and commercialization of its liquid biopsy products, as well as for establishing collaborations with various cancer treatment institutions.