NEW YORK—Since acquiring Advanced Cell Diagnostics more than a year-and-a-half ago, Bio-Techne says it has seen solid growth, and notes that it is creating a new division for genomic technology that came with ACD. Although the technology—which provides highly sensitive RNA-based tissue analysis and has been housed in Bio-Techne’s biotechnology division—is growing at about 40 percent, mostly in biotech and academic research applications, significant potential exists to drive product sales in immunohistochemistry diagnostics over the longer term, according to the company’s executives.
The Minneapolis-based life-sciences tools and diagnostics firm took ownership of the RNA in-situ hybridization technology, called RNAscope, when it purchased ACD for $325 million in August 2016, launching Bio-Techne into the genomics space.
The technology enables researchers to visualize gene expression in individual cells while retaining information on tissue morphology, and is far more sensitive and effective than existing antibody-based immunohistochemistry detection that analyzes cells for cancerous tumors, according to Bio-Techne President and CEO Charles Kummeth.
RNAscope’s multiplex nucleic acid in-situ hybridization technology uses a probe design and signal amplification that serves as an alternative to conventional in-situ hybridization/in-situ fluorescence (ISH/FISH) RNA detection. The method, Bio-Techne said, enables pathologists to profile single-cell gene expression in situ with single-molecule detection sensitivity.
To date, the technology has been used mostly in research settings, but the push into the clinical diagnostic space has already begun. Bio-Techne has a partnership with Danaher’s Leica Biosystems, which “has done all the regulatory work” for a tissue-based diagnostic test for human papillomavirus using RNAscope, Kummeth said, adding, “The idea here is to keep adding on tissue-based diagnostics with partners like Leica” that have in-vitro diagnostic regulatory expertise.
ACD grew more than 40 percent in 2017, and is expected to grow 40 percent or more again this year, driven by its reach into pharma and academic research and, longer term, by its entry into clinical diagnostics, Leerink research analyst Puneet Souda said in an interview.
He noted that the technology has potential for growth as a tissue test used during drug research and as a companion diagnostic to aid in the selection of patients during clinical trials, because it shows better sensitivity and specificity than other tools employed in tissue-based immunohistochemistry diagnostics. Souda added that he expects that RNAscope will add $50 million to Bio-Techne’s revenues in fiscal year (FY) 2018 revenues.
“The number one driver for ACD business growth is a transition in the immunohistochemistry marketplace from an antibody-based pathology using IHC, to molecular pathology,” Kummeth said.
However, he noted that the ACD business is only one among several growth drivers that have taken the firm from $311 million in annual revenues in FY 2013 to $563 million in FY 2017, and these initiatives are expected to help drive greater than $1 billion in revenues in 2022.
The company is also expanding into “branded diagnostics with content-based solutions,” Kummeth reported. In addition to the ACD purchase, Bio-Techne bought ProteinSimple in 2014 for $300 million in cash, giving the company Simple Plex assays and products. These products have potential for use in clinical trials during drug development and later as companion diagnostics to aid in selecting patients.
In addition, the firm has announced two companion diagnostics efforts, with Bayer and Merrimack, and Bio-Techne also has an investment in Astute Medical, a company that manufactures and markets U.S. Food and Drug Administration-cleared diagnostic tests for acute kidney injury, which use Bio-Techne’s biomarkers.