Helixgate

Helixgate

Uncategorized

Proteins.1 Launches to Develop Single Molecule Protein Amplification Tech for Diagnostics

Published

on

Finnish deep-tech startup, Proteins.1, launched with €4.7 million in pre-seed funding, led by Lifeline Ventures and Cloudberry Ventures, with in-kind support from VTT and Business Finland. Harnessing technology transferred from VTT Technical Research Centre of Finland, Proteins.1 is developing a PCR-like enzyme-free, ultra-sensitive amplification platform for the detection of proteins at the single-molecule level. The firm says it aims to transform early disease diagnostics by enabling detection of disease-related molecular warning signals long before there are clinical signs.

While polymerase chain reaction (PCR) technology has transformed modern diagnostics by allowing tiny amounts of DNA to be amplified into detectable signals, no equivalent amplification method has existed for proteins, which often signal the earliest onset of cancer, neurodegeneration, cardiovascular disease, and inflammatory conditions, the company notes. Proteins.1 aims to leverage its technology to establish a new category of ultra-sensitive protein diagnostics, combining high multiplexing, scalable chip-based detection, and significantly lower capital costs compared to existing systems.

The patented, physics-based technology introduces cyclic signal amplification for proteins, potentially enabling up to 1,000 times better sensitivity than current gold-standard platforms, Proteins.1 claims. Unlike conventional immunoassays that rely on enzymatic reactions prone to variability and noise, the Proteins.1 approach is solid-state, enzyme-free, and compatible with semiconductor-based photonic detection.

The platform replaces enzymatic signal amplification with a physics-based magnetic cycling mechanism that repeatedly reads a single captured protein molecule, accumulating signal clarity without increasing background noise. The company says this supports ultra-high sensitivity combined with high multiplexing, potentially enabling the simultaneous measurement of hundreds of biomarkers from a few drops of blood.

“For decades, diagnostics has been limited not by biology, but by what our instruments can detect,” commented Proteins.1 co-founder and CEO Prateek Singh, who is inventor of the core technology. “The body produces early warning signals long before disease becomes visible. Our mission is to make those signals measurable and actionable, years earlier than today.”

Built on research conducted at VTT and further validated through European Union breakthrough innovation funding, the technology has been granted U.S. and Finnish patents, and additional international applications are pending. Initially, the company aims to develop research-use-only applications in oncology, neurology, and immunology, before progressing toward regulated clinical diagnostics. “Early detection dramatically improves survival rates in diseases such as cancer and neurodegenerative disorders,” Singh continued. “If we can detect disease at the molecular stage rather than the symptomatic stage, we entirely change treatment possibilities.”

Proteins.1 plans to expand its engineering and product development team in Finland during 2026–2027, positioning itself as a European hub for next-generation diagnostic technology. “Proteins.1 represents the kind of deep scientific breakthrough that can redefine an entire industry,” said Jyri Engeström at Lifeline Ventures. “The team combines world-class research with proven experience in building and scaling regulated medtech businesses.” Cloudberry Ventures further highlighted the company’s strong alignment with European strengths in photonics, microfabrication, and precision engineering.

Added Rene Kromhof, at Cloudberry VC, “What sets Proteins.1 apart is a fundamentally new sensing approach. Rather than using enzymes that give you one chance to detect a protein, they use light and thin-film transistors to amplify the signal from a single protein until it rises above the noise. That dramatically improves sensitivity, and ultimately, how early disease can be caught.”

CEO Prateek Singh has previously raised venture capital for microfluidics ventures and holds multiple patent families. Co-founder and COO Harri Hallila previously built and exited a regulated medical device company. The broader team includes commercial leadership with experience in leading diagnostics platforms.

The post Proteins.1 Launches to Develop Single Molecule Protein Amplification Tech for Diagnostics appeared first on GEN – Genetic Engineering and Biotechnology News.

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Uncategorized

Pharma-backed petition calls on FDA to reform release of drug rejection letters

Published

on

The FDA for the first time is facing pharma-backed criticism of its new practice of publicly releasing partially redacted drug rejection letters.

The law firm Covington & Burling, on behalf of an unnamed pharmaceutical company …

Continue Reading

Uncategorized

Viral Contamination Still a Challenge for CGT Industry

Published

on

Raw material testing will remain the foundation of cell and gene therapy (CGT) sector quality control strategies for the foreseeable future, according to new analysis, which shows the industry still lacks suitable virus detection and inactivation methods.

Biopharmaceutical raw materials—the culture media ingredients, the reagents, and even the production cell lines themselves—are the biggest source of viral contamination in drug manufacturing.

To mitigate the risks, the protein drug industry has developed downstream virus detection, inactivation, and removal strategies to make sure products do not pose an infection risk.

For CGT firms, ensuring products are virus safe is more of a challenge, says Yoshiaki Maruyama, PhD, from the office of cellular and tissue-based products at Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

“Viral contamination of CGT products may arise from virus-contaminated raw materials or ancillary materials of human or animal origin or from the inadvertent introduction of viruses during the manufacturing process.

“Appropriate raw material controls and robust quality control parameters must be established and maintained throughout the manufacturing process to effectively manage the risk of viral contamination,” he tells GEN.

Inactivation and removal challenges

The big problem is that cell and gene therapies are too sensitive to survive current viral inactivation methods, most of which were developed with protein therapeutics in mind.

Maruyama says, “Most conventional virus inactivation or removal processes inevitably result in cell damage or loss in cell therapy and tissue-engineered products or adversely affect viral vectors in gene therapy products.”

As a result, CGT sector quality control efforts have focused on screening raw materials and finished products, according to Maruyama, who looked at current regulations and common approaches in a recent study.

“In the CGT sector, viral safety is achieved by implementing a comprehensive viral testing program. The use of inactivation and removal processes is challenging for CGT products and raw materials, so quality control strategies relying on screening are generally used,” he says.

Technological solutions?

In future, technologies may play a greater role, according to Maruyama, who says, “

“NGS technologies are expected to be applicable to the detection of adventitious viruses in human or animal cells. NGS offers a powerful, unbiased approach for detecting known and unknown viral contaminants,” they write.

However, as the authors point out, further development will be required as NGS systems detect nucleic acids rather than viable, infectious virus particles.

“Currently, there are no globally accepted NGS-based procedures or validated analytical methods that have reached a consensus on their use as substitutes for conventional viral tests. Therefore, the use of NGS as an alternative to conventional viral tests, including reducing the use of experimental animals, requires further evaluation depending on the specific test to be replaced,” they write.

And in the future, artificial intelligence (AI) systems may also play a role.

“This is largely speculative, and there are currently no concrete examples, but AI-based tools have been applied to manufacturing control for deviation prediction and similar approaches might also be useful for controlling viral contamination risks in CGT products and raw materials,” he says.

The post Viral Contamination Still a Challenge for CGT Industry appeared first on GEN – Genetic Engineering and Biotechnology News.

Continue Reading

Uncategorized

Revolution drug shows promise in early pancreatic cancer

The findings build on data suggesting Revolution’s therapy could upend treatment for a notoriously tough-to-treat tumor and generate billions in sales.

Read More

Published

on

The findings build on data suggesting Revolution’s therapy could upend treatment for a notoriously tough-to-treat tumor and generate billions in sales.

Read More

Continue Reading
Advertisement

Trending