Molecular diagnostic and antibody research get a boost

Two diagnostics-related acquisitions were announced in March, each aimed at streamlining and enhancing researchers’ work—ABclonal Biotechnology Co. Ltd. brought Yurogen Biosystems LLC into its fold, and Bio-Techne Corp. shared news of a deal to acquire genetic carrier screening and oncology testing company Asuragen Inc.

Early in the month, Boston-based global life-science tools and services provider ABclonal Biotechnology acquired Yurogen Biosystems, a contract research organization (CRO) dedicated to monoclonal antibody discovery using a B cell-based SMab platform in order to better serve researchers in in vitro diagnostic, antibody drug, and therapeutic discovery markets worldwide. This came after the company announced a $93-million Series C funding round and marks the first step in its expansion from academic research reagents production to in vitro diagnostic and pharmaceutical industries. 

The company’s subsidiary, ABclonal Technology, began collaborating with Yurogen Biosystems in 2017 and says the pursuit for high-quality products and desire for innovation was the driving force behind both the initial collaboration and present acquisition.

The acquisition will allow ABclonal to produce recombinant rabbit monoclonal antibodies using SMab, Yurogen’s proprietary monoclonal antibody production platform. This single-B-cell-based technology reportedly will make way for high-throughput development of high-affinity, high-specificity monoclonal antibodies, significantly surpassing production capabilities of traditional technologies like hybridoma and phage display—enabling ABclonal to fully embrace the in vitro diagnostic and antibody drug discovery markets worldwide.

Compared to polyclonal antibodies and hybridoma-based monoclonal antibodies, the quality of recombinant antibodies is highly stable. The use of rabbits during the initial processes results in an antibody repertoire with high affinity, strong specificity, and broad diversity, allowing companies to better meet the demand for experiment validity and repeatability in scientific research and biomedical innovation. Additionally, large-scale production of such antibodies are able to be completed independent of animals.

ABclonal Biotechnology plans to invest $30 million to launch more than 10,000 new recombinant rabbit monoclonal antibody products for the global scientific research community and in vitro diagnostic market in the next three years. These products will encompass research areas such as neurobiology, developmental biology, and immunology, and cover diagnostic platforms including enzyme-linked immunoassay, colloidal gold, chemiluminescence, and flow cytometry. For antibodies developed under this project, knockout validation will become the routine screening and validation procedure to maintain the quality of raw materials in in vitro diagnostics and biopharmaceutical development.

Founded in 2014, Yurogen has developed its proprietary SMab technology for use in therapeutic leads, diagnosis, preclinical studies, and clinical trials. Since the offering of CRO services in 2016, Yurogen delivered more than 500 projects globally with a 98-percent success rate to over 80 different industrial clients from biopharma and biotech sectors.

“Recombinant monoclonal antibodies are the future of diagnostic and pharmaceutical research,” said Zack Wu, CEO at ABclonal. “In the medical research community, there is an increasing need for reagents with little to no batch-to-batch variation because of the rising demand for experiment replicability. Traditional antibodies such as polyclonal antibodies and hybridoma-based monoclonal antibodies simply cannot meet the requirements in the market. Because of that, the industry is experiencing an important transformation—a shift from traditional rabbit polyclonal antibodies and mouse hybridoma toward recombinant monoclonal antibodies.”

Meanwhile, Bio-Techne announced an agreement to acquire Asuragen for initial consideration of $215 million in cash, plus contingent consideration of up to $105 million upon the achievement of certain future milestones. With an expected closing date in the fourth quarter of its fiscal 2021, the transaction will be financed through a combination of cash on hand and an existing revolving line of credit.

“The Asuragen team is extremely excited to be joining Bio-Techne at this point in our growth trajectory,” commented Matt McManus, CEO of Asuragen. “Bio-Techne’s global presence, reputation, and relationships within the clinical diagnostic and research communities will enable Asuragen to broaden our reach and accelerate penetration into the high-growth molecular diagnostic markets addressed by our portfolio. I am honored to continue to lead the Asuragen team as a part of Bio-Techne. I would like to thank all of the great people of Asuragen for their committed efforts growing our company to this point and am looking forward to the next stage of growth under the Bio-Techne umbrella.”

Founded in 2006, Texas-based Asuragen is a leader in the development, manufacturing, and commercialization of genetic carrier screening and oncology testing kits, whose projects leverage proprietary chemistries which can be used on widely available platforms including, PCR, qPCR, capillary electrophoresis, and next-generation sequencing instruments. 

The platform-agnostic approach enables its clinical laboratory customers to solve complex molecular diagnostic challenges and empowers hospital and regional labs to expand in-house testing capabilities, furthering the decentralization of the molecular diagnostics market, enabling quicker turn-around times and ultimately delivering better patient care. Following this transaction, McManus will join the Bio-Techne team to continue to lead the legacy Asuragen business as well as the integration process.

Asuragen carries with it a portfolio of molecular diagnostic and research products, including its FDA-cleared AmplideX Fragile X Diagnostic and Carrier Screening kit for the screening of prospective parents as potential carriers of Fragile X chromosomal abnormalities, as well as its Quantitidex qPCR IS BCR-ABL kit to enable the monitoring of leukemia patients for minimal residual disease. 

Additionally, Asuragen’s pipeline includes expanded carrier screening panels for various pathologies recognized by The American College of Obstetricians and Gynecologists as areas of concern for prospective new parents. This acquisition provides Bio-Techne multiple growth synergies following the closing of the transaction, including Asuragen’s capabilities and proven track record in productizing lab-developed tests and commercializing innovative molecular products for broader market adoption.

“Asuragen is very complementary with Bio-Techne’s existing diagnostics franchise, and the addition of this business is expected to drive growth synergies throughout the expanded portfolio,” stated Chuck Kummeth, president and CEO of Bio-Techne. “We are not only acquiring a financially strong and scalable business, but are also adding a team with deep expertise in the intricacies of the global regulatory environment and a proven track record of opening new market channels. 

“This critical mass will be very beneficial to the Genomics and Diagnostics Segment as we commercialize our pipeline of liquid biopsy tests through our Exosome Diagnostics business, and also opens the possibility of approaching the market with kitted versions of these products. We anticipate continued traction with Asuragen’s leading portfolio of molecular diagnostic kits for both clinical and research uses and see significant potential in its pipeline of expanded carrier screening panels. Asuragen is a great addition to the Bio-Techne team.”

ABclonal Biotechnology Co. Ltd. https://abclonal.com/

Yurogen Biosystems LLC http://www.yurogen.com/

Bio-Techne Corp. https://www.bio-techne.com/

Asuragen Inc. https://asuragen.com/