Synthego Announces Entry into Molecular Biology and Clinical Diagnostic Reagents Market

Redwood City, CA – 1/13/2025 – Synthego, a recognized leader in CRISPR solutions, announces its formal entry into the molecular and clinical diagnostic reagents sector. Building upon its reputation for rigorous quality, custom manufacturing, and innovation, Synthego’s significant expansion of its product portfolio empowers researchers, clinicians, and diagnostic laboratories with high-quality, reliable reagents designed to accelerate the development and deployment of cutting-edge diagnostic tests.  

Expanding the Synthego Portfolio 

The decision to enter the molecular and clinical diagnostics space is a strategic one for Synthego, leveraging its world-class expertise in synthetic biology and CRISPR-based technologies. By providing novel, engineered enzyme solutions designed for more robust and rapid molecular assays with reagents tailored for diagnostic applications and customer-friendly pricing, the company aims to address growing market demand for robust, scalable, and accurate solutions essential for disease detection, monitoring, personalized medicine and industrial solutions. This portfolio expansion is driven through a growing collaboration with biotechrabbit GmbH, experts in enzyme manufacturing for diagnostic-grade quality reagents and assays.   

Driving Innovation in Diagnostics 

Synthego’s new line of molecular and clinical diagnostic reagents will include components for nucleic acid amplification, detection, and quality control, supporting a broad range of applications such as infectious disease screening, genetic disorder analysis, oncology, and companion diagnostics. These reagents are manufactured under stringent ISO 13485 and ISO 9001 quality systems, ensuring consistency, reproducibility, and compliance with industry standards. Additionally, Synthego offers product customization - including extensive lyophilization capability - to fit seamlessly into customer-optimized workflows including lyophilization into bespoke devices, supporting everything from complex molecular assays to routine bench science and optimized PCR master mixes. 

Commitment to Quality and Accessibility 

“Synthego’s expansion into molecular and clinical diagnostics represents a pivotal step in our mission to bridge the gap between discovery and patient impact,” said Craig Christianson, CEO of Synthego. “By integrating biotechrabbit’s world-class development and manufacturing expertise with our scale, we are ensuring that the next generation of diagnostic tools is not only highly reliable but also globally accessible to those who need them most.”

“Synthego’s entry into the molecular biology and clinical reagents space marks a significant milestone in their growth. We are excited to see the company apply its rigorous quality standards to the diagnostic sector, ensuring that researchers and clinicians have access to the reliable reagents required for high-stakes disease detection and personalized medicine.” — Sam Chawla, Perceptive Advisors

Supporting Global Health and Research

With the launch of these diagnostic reagents, Synthego intends to collaborate closely with academic, clinical, and industry clients. The company’s goal is to enable faster delivery of validated diagnostic assays to the market, ultimately contributing to improved global health outcomes and advancing the frontiers of precision medicine. 

Continued Growth and Evolution 

Synthego enters 2026 with a strong emphasis on continued growth. 2025 was a big year, including a sale of assets to funds owned by Perceptive Advisors and emerging from related Chapter 11 protection as Synthego Holdings LLC. Additional new product lines will be announced as 2026 progresses, as Synthego continues to grow its manufacturing and quality expertise serving our clients and their most pressing research and therapeutic needs, ever-advancing developments in human health.  

 

News Feed:  https://www.biospace.com/press-releases/synthego-announces-entry-into-molecular-biology-and-clinical-diagnostic-reagents-market

Related News:  https://galleon-stage.synthego.com/blog/synthego-launches-molecular-reagents-for-diagnostics-research/

About Synthego 

Synthego is a pioneering biotechnology company specializing in synthetic biology and genome engineering. Dedicated to providing scientists with the tools, expertise, and support needed to accelerate scientific discovery, Synthego’s expansion into molecular and clinical diagnostic reagents reaffirms its commitment to innovation and leadership in the life sciences industry. 

For more information, please contact: 

Synthego Media Relations 
Email: [email protected]
Website: www.synthego.com 

Synthego Launches High-Performance Molecular Reagents for Clinical and Molecular Diagnostics

REDWOOD CITY, CA – November 10, 2025

Synthego, a leading provider of CRISPR solutions, has announced a strategic expansion of its product offerings with the launch of a new portfolio of high-performance molecular reagents. Building on its established leadership in CRISPR gene editing, Synthego now delivers essential PCR enzymes, RNA synthesis tools, and advanced isothermal amplification kits designed to meet the stringent requirements of diagnostic laboratories as well as the evolving needs of molecular biology research. The launch addresses the growing demand for robust solutions designed to support the full spectrum of molecular biology and diagnostics workflows and accelerate the path from discovery to validation.

With these molecular reagent solutions, Synthego empowers scientists, clinicians, and researchers to address challenges such as assay sensitivity, workflow scalability, and reproducible performance across a broad range of sample types. These solutions are developed to provide the accuracy, reliability, and consistency critical for confident clinical decision-making, research innovation, and scalable, high-throughput testing. Additionally, Synthego offers product customization - including lyophilization - to fit seamlessly into customer-optimized workflows, supporting everything from complex molecular assays to routine bench science.

By expanding its expertise into these foundational areas, Synthego reaffirms its commitment to equipping the scientific community with the critical tools necessary to drive innovation and achieve breakthroughs in genomics, therapeutics, and molecular and clinical diagnostics.

Learn more about Synthego’s molecular diagnostics and molecular biology products.

Synthego Announces Successful Close of Acquisition by Perceptive Advisors

REDWOOD CITY, CA – July 21, 2025

Synthego, a leading provider of CRISPR solutions, today announced the successful closing of the acquisition of substantially all of its assets by funds managed by Perceptive Advisors, a leading life sciences investment firm. The transaction officially closed on July 18, 2025.

Under the new ownership of the Perceptive funds, Synthego will continue its operations as normal, maintaining its commitment to delivering high-quality CRISPR products and services to its global clientele. The company’s leadership team and dedicated staff remain in place, ensuring seamless continuity in day-to-day operations and customer support. The Synthego brand identity will continue, and the web and email domain remain synthego.com.

"We are thrilled to officially complete this transaction and embark on a new chapter with Perceptive Advisors," said Craig Christianson, CEO of Synthego. "This partnership strengthens our financial position and provides us with enhanced resources to accelerate innovation and expand our product portfolio in the months ahead. We remain fully committed to supporting our clients in their groundbreaking research and therapeutic development efforts."

The Perceptive funds’ acquisition reinforces Synthego's mission to empower scientific discovery through advanced genomic engineering. Synthego will continue to manufacture its best-in-class guide RNA in Redwood City, California, ensuring this essential component is made in the USA and supports the development of CRISPR-based therapies for the global market. Synthego launched a GMP offering of SpCas9 in May and recently expanded gene editing options with launches of eSpOT-ON and Accubase™ enzymes in July, along with related guide RNA offerings.

"We're incredibly excited about working closely with Perceptive Advisors. Our customers' successes inspire us daily, and this partnership ensures we can both expand our offerings and accelerate our mission to deliver the most advanced and reliable CRISPR solutions for their critical work." said Jason Miller, Chief Commercial Officer of Synthego.

About Perceptive Advisors - Founded in 1999 and based in New York, NY, Perceptive Advisors is an investment management firm with approximately billion in assets.  Perceptive Advisors is focused on supporting the progress of the life sciences industry by identifying opportunities and directing financial resources to the most promising technologies in healthcare. For more information visit www.perceptivelife.com.

Synthego Gains Approval to Proceed with Sale to Perceptive Advisors; Transaction Set to Close in July

Redwood City, CA — June 26, 2025

Synthego, a leading provider of CRISPR solutions, today confirmed that its sale to Perceptive Advisors, a global life sciences investor known for backing leading biotech companies, is cleared to close. This transaction, expected to close in July, will provide Synthego with a strengthened balance sheet and a clear path to expand its product portfolio, make strategic investments, and empower clients to advance curative therapeutics worldwide.

"We’re thrilled to be moving forward with Perceptive Advisors as our new owner," said Craig Christianson, Chief Executive Officer of Synthego. "This acquisition renders our business stronger than ever, with a committed investor that provides us with the resources and stability to accelerate CRISPR innovation, deliver more value to our clients and support the next generation of curative therapies."

"We are proud to support Synthego and its leadership team and look forward to closing this strategic transaction," said Sam Chawla, Portfolio Manager at Perceptive Advisors. "Synthego’s dedication to driving scientific progress makes them a valuable partner in advancing the broader biotech ecosystem. We look forward to supporting their continued success and growth through well-funded innovation and product launches."

Synthego will continue to manufacture its industry-leading guide RNA in Redwood City, California. Current Synthego facilities include two factories, research laboratories, offices, warehousing and logistics. This structure ensures that target sequences and custom modifications of CRISPR gRNA therapies remain in the USA for production. Day-to-day operations and customer support are expected to continue without disruption throughout this process. The experienced leadership team and staff will remain in place, with plans to add new roles as the business continues to grow.

Christianson added, "We are a unique American manufacturer in our field, with a stand-out capability to serve clients advancing curative therapies through the FDA process, and support researchers without tariff-induced price increases. We are excited to build on this momentum, invest in our future, and continue delivering the high-quality tools and support our clients rely on to advance the next generation of cell and gene therapies."

About Perceptive Advisors

Perceptive Advisors, founded in 1999, manages a portfolio of approximately billion across more than 80 companies at the forefront of biotechnology and therapeutic development. Its deep expertise and vision for advancing human health align with Synthego’s mission to deliver high-quality tools and services for CRISPR-based research and therapies.

Synthego Prevails In Patent Appeal Confirming Agilent CRISPR Patents Are Invalid

REDWOOD CITY, CA - Synthego, a pioneering CRISPR Solutions provider, is pleased to announce that the US Court of Appeals for the Federal Circuit has upheld an earlier ruling invalidating patents held by Agilent Technologies, Inc. See the ruling here.

In the original case, ruling dated May 17, 2023, the Patent Trial and Appeal Board (PTAB) ruled in favor of Synthego’s petitions seeking to invalidate Agilent’s US Patents Nos. 10,337,001 (the ’001 patent) and 10,900,034 (the ’034 patent) in the Inter Partes Review before the PTAB.

The PTAB's original decision invalidated all claims of the Agilent patents, which were directed to guide RNAs having at least one 2’-O-methyl modification (‘034 patent) and guide RNAs having certain modifications within 5 nucleotides of their 5’ and/or 3’ end (‘001) patent), as well as methods of using such modified guide RNAs for CRISPR gene editing.

“This critical decision, affirming that Agilent's claims on chemically modified gRNAs are unpatentable, keeps the path clear for broader innovation and advancement in the CRISPR therapeutics market,” said Craig Christianson, CEO of Synthego. “Synthego will continue our focus on supporting our clients’ efforts to enhance human health with curative cell and gene therapies.” 

Synthego continues to support innovation in the field of CRISPR-enabled research and therapeutics, this affirmation enables researchers and therapeutic developers to continue to drive successful patient outcomes.

Synthego Introduces GMP SpCas9 to Accelerate Gene Editing for Therapeutic Advancement

Redwood City, 12 May 2025 - Synthego has expanded its CRISPR solutions portfolio with the launch of GMP SpCas9, offering researchers a powerful solution to enhance CRISPR-based therapeutic development. The launch of GMP SpCas9 enables researchers to bundle the nuclease with IND-enabling or GMP sgRNAs into a convenient, unified package, optimizing processes and driving therapeutic progress.

Produced under certified cGMP manufacturing standards, GMP SpCas9, in combination with best-in-class GMP sgRNAs, provides researchers with a comprehensive CRISPR solution that ensures exceptional quality, consistency, and scalability required for therapeutic applications. Further supporting development, Synthego offers access to Drug Master Files (DMFs) with unified regulatory documentation for both GMP sgRNAs and GMP SpCas9, simplifying regulatory submission filings and reducing complexity.

"We are excited to expand our portfolio of best-in-class CRISPR solutions to include a GMP SpCas9 nuclease. With this addition, we now provide the highest quality CRISPR-based gene editing tools desired for human clinical studies, at a budget-friendly price. It is our continuing mission to democratize CRISPR at both the academic and clinical research phase without compromising on quality," said Jason Miller, Chief Commercial Officer.

Through the launch of GMP SpCas9 and its seamless integration with GMP sgRNAs, Synthego continues to deliver cutting-edge CRISPR solutions that empower therapeutic developers to accelerate progress in CRISPR-based cell and gene therapies. Discover more about GMP SpCas9 and GMP sgRNAs by visiting the product page or contacting our experts to start your GMP project.

Synthego Initiates Strategic Financial Restructuring to Facilitate Sale, Reduce Debt, Strengthen Balance Sheet

REDWOOD CITY, CA, May 5, 2025

Synthego, a leading supplier of CRISPR solutions, today announced that it has ensured its future success by entering into a purchase agreement with Perceptive Advisors to acquire all the assets of the Company on a going-concern basis. To facilitate the sale, the Company has voluntarily initiated a Chapter 11 proceeding in the United States Bankruptcy Court of the District of Delaware. Along with the Asset Purchase Agreement and bankruptcy petition, Synthego filed papers seeking court approval of up to 2.5 million in Debtor-in-Possession financing from Perceptive to support continued operations and the restructuring process. The sale is expected to close in 70 days.

"Today's actions were the best way to efficiently reduce our debt obligations and ensure that Synthego is well-positioned for the future. We are pleased that our secured lender, Perceptive, understands Synthego’s unique value as a biotech innovator, accelerating the development of next-gen medicines and therapies," said Craig Christianson, Chief Executive Officer of Synthego. "Perceptive is well-known in the industry for backing the most promising biotech companies and breakthroughs, and we couldn’t ask for a better capital partner." 

The Company expects day-to-day business operations to continue as usual, and does not anticipate changes to its management team, staffing, the services it provides, or any direct impact on customers during this transition process. 

"The remarkable achievements of our customers are a testament to their innovative spirit and commitment to improving human health. Synthego is honored to be a trusted partner in their journey, providing high-quality CRISPR solutions and the manufacturing excellence needed to unlock the next era of therapeutic advancement," said Jason Miller, Chief Commercial Officer of Synthego.

Over the next couple of months, as required by the Bankruptcy Code, the Company, through its investment banker – Raymond James – will run a Court-supervised sale and auction process to solicit competing bids, so that Synthego can assure the Court that the Company receives the highest and best bid for its assets. If no higher and better bids are received, Synthego will proceed to close the transaction with Perceptive on the agreed-upon terms. 

Continued Christianson, "at the end of this process, we see tremendous opportunity, including a committed majority owner, an improved capital structure, and the ability to continue our growth trajectory."

Synthego and Vita Therapeutics Announce Strategic Licensing Agreement for hfCas12Max CRISPR Nuclease

REDWOOD CITY, CA

Synthego and Vita Therapeutics, Inc. today announced a licensing agreement to integrate Synthego’s high-fidelity hfCas12Max CRISPR system into Vita's cell therapeutic programs. This nonexclusive sublicense grants Vita Therapeutics access to the engineered hfCas12Max nuclease and optimized hfCas12Max guide RNAs for use in preclinical and clinical applications, including in potential commercialized therapeutics. 

"With the integration of hfCas12Max, Vita Therapeutics can accelerate the development of their hypoimmunogenic cell therapies, paving the way for life-changing treatments to reach patients sooner," said Craig Christianson, CEO of Synthego. "Our goal is to make therapeutic CRISPR solutions more accessible by removing traditional bottlenecks with reduced upfront licensing fees and a lower total IP cost as the therapy advances."

Synthego introduced the hfCas12Max CRISPR system in 2024, the first in its portfolio of high-fidelity nucleases designed specifically for therapeutic applications. "With encouraging early performance data, Vita Therapeutics plans to leverage hfCas12Max to develop hypoimmunogenic master cell banks (MCBs), which will serve as a critical platform for advancing our iPSC-based therapies for neuromuscular disorders. We’re excited about this partnership and the impact it can have on the patients we’re hoping to treat" said Douglas Falk, CEO of Vita Therapeutics. 

With the recent addition of eSpoT-ON, offered in both recombinant protein and mRNA formats, Synthego continues to elevate its high-fidelity nuclease portfolio, delivering new opportunities for therapeutic advancement. 

Are you ready to advance your therapeutic program? Contact us to learn more.

Learn more about all our nuclease offerings here.

Discover how Synthego reduces IP barriers here.

Synthego Signs Strategic Agreement with AstraZeneca to License CRISPR Gene Editing Enzyme eSpOT-ON

REDWOOD CITY, CA, January 13, 2025 –

Synthego, a leading supplier of CRISPR solutions, has entered a strategic licensing agreement with global biopharmaceutical company AstraZeneca. This agreement grants Synthego a global license to manufacture and distribute AstraZeneca's novel CRISPR gene editing enzyme, eSpOT-ON, recently published as engineered ePsCas9, to the worldwide research community. This state-of-the-art nuclease, developed by AstraZeneca will be paired with Synthego’s best-in-class gRNA to enable improved health outcomes. The eSpOT-ON nuclease will be offered as recombinant protein and mRNA formats by Synthego.

Under the terms of the agreement, Synthego also receives exclusive commercialization rights including the right to sublicense this nuclease for therapeutic and commercial use. 

"Our agreement with AstraZeneca is a testament to our commitment to guiding researchers with customized CRISPR solutions that empower their therapeutic pursuits," said Craig Christianson, CEO of Synthego. "By enhancing our CRISPR expertise with AstraZeneca's novel nuclease, we are poised to expedite the development of transformative therapies, paving a streamlined and accelerated path to clinical advancement,"

Synthego's innovative approach simplifies the licensing process for CRISPR cell and gene therapies, ensuring that novel and groundbreaking nucleases and gRNAs are within reach for researchers. The company's extensive regulatory and technical expertise further bolsters the therapeutic development pipeline, providing a seamless integration from concept to clinic.

"We are excited to offer significantly lower upfront fees for rights to a leading CRISPR enzyme enabling therapeutic developers to de-risk their fundraising process, and making overall development costs significantly less than with traditional nucleases," continued Christianson.

This licensing agreement marks a significant milestone in the field of CRISPR therapeutics, combining the strengths of Synthego's advanced solutions with AstraZeneca's innovative gene therapy technology. We aim to push the boundaries of medical science, ultimately bringing more effective treatments to patients worldwide.

For more information about Synthego, please visit Synthego.com.

Synthego Launches High-Value IVT Enzymes for Advanced RNA Therapeutics

REDWOOD CITY, CA, November 4, 2024 –

Synthego has expanded its solutions portfolio with the introduction of high-performance RNA enzymes, T7 RNA Polymerase and RNase Inhibitor, further enhancing its capabilities to serve the RNA research and therapeutic markets. These newly launched in vitro transcription (IVT) enzymes are specifically designed to address critical challenges in RNA synthesis and manipulation, complementing Synthego’s industry-leading gRNAs.

The T7 RNA Polymerase enables efficient RNA synthesis with high yield and purity, making it ideal for applications such as mRNA therapeutics, gene editing platforms, and synthetic biology workflows. Complementing this, the RNase Inhibitor safeguards RNA integrity by protecting against degradation during complex workflows, ensuring reliability and consistency in sensitive experiments. Together, these enzymes empower researchers with tools designed to streamline processes and optimize results, from discovery through clinical development.

Together, these enzymes integrate seamlessly with Synthego's best-in-class gRNA solutions, providing researchers with a complete and robust toolkit for applications ranging from RNA therapeutic development to gene editing and prime editing. With these tools, researchers can confidently accelerate the progression of RNA-centric projects, from initial discoveries to advanced therapeutic development. For detailed specifications, visit our T7 RNA Polymerase and RNase Inhibitor product pages.