COMPANY:

Bio-Techne

"Bio-Techne Corporation...announced that a newly finalized local coverage determination (LCD) from National Government Services, Inc., a Medicare Administrative Contractor, includes coverage for the ExoDx™ Prostate Test from Exosome Diagnostics, a Bio-Techne brand. The updated policy now covers an annual ExoDx Prostate Test for men who already had a negative biopsy but are thought to be at high risk for prostate cancer and are considering a repeat biopsy. The coverage will go into effect March 1, 2023."

"Bio-Techne...announced the European launch of the CE-IVD marked RNAscope ISH Probe High Risk HPV, intended for use in patients diagnosed with oropharyngeal squamous cell carcinoma (OPSCC) to aid in the identification of high-risk human papillomavirus (HPV)."

"Nonagen Bioscience and Bio-Techne Corporation...announced an agreement for R&D Systems, a Bio-Techne brand, to exclusively manufacture Nonagen Bioscience’s Oncuria® bladder cancer diagnostic panel using xMAP Luminex® technology...Nonagen Bioscience and Bio-Techne are targeting the last quarter of calendar 2022 to make Oncuria available as an LDT."

"Bio-Techne Corporation...announced that Exosome Diagnostics...will have a major scientific presence at the annual American Urological Association Conference (AUA) taking place May 13-16 in New Orleans, LA. Exosome Diagnostics will have two poster presentations, including a podium presentation, six in-booth scientific presentations...Additional presentations include results of the ExoDx™ Prostate test clinical utility study as well as a 2.5 year follow-up and interim analysis of subjects who participated in the study and will conclude with the combined performance of the ExoDx Prostate test and MRI in the early detection of prostate cancer."

"Bio-Techne Corporation...announced an important publication in World Journal of Urology, entitled Pre–diagnosis urine exosomal RNA (ExoDx EPI score) is associated with post–prostatectomy pathology outcome...The significance of this study is that in men with an EPI score below the cut-point of 15.6, the ExoDx Prostate test could prevent low-risk men from proceeding to radical prostatectomy."

"Bio-Techne Corporation...today announced that Exosome Diagnostics, a Bio-Techne brand, has published important clinical research in the journal Prostate Cancer and Prostatic Diseases, entitled Predicting high-grade prostate cancer at initial biopsy: clinical performance of the ExoDx (EPI) Prostate Intelliscore test in three independent prospective studies. In this pooled analysis from three independent prospective-validation studies and more than 1200 subjects...demonstrated the ExoDx Prostate test, or EPI, can discriminate high-grade (≥GG2) from low-grade (GG1) cancer and benign disease. In the pooled cohort, the validated cut-off of 15.6 would avoid 23% of all prostate biopsies and 30% of 'unnecessary' (benign or Gleason 6/GG1) biopsies, with a negative predictive value (NPV) of 90%."

"Bio-Techne Corporation...today announced a license agreement for use of a proprietary Bio-Techne antibody by Xencor, Inc., a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, for its therapeutic development pipeline...Under the terms of this agreement, Bio-Techne grants Xencor access to a proprietary Bio-Techne antibody for use with their proprietary XmAb® protein engineering technology, which is revolutionizing the development of new cancer therapeutics such as bispecific antibodies and engineered cytokines."

"Bio-Techne Corporation...today announced it has completed the acquisition of Asuragen, Inc. The transaction included initial consideration of $215 million in cash plus contingent consideration of up to $105 million upon the achievement of certain future milestones. The Asuragen acquisition adds a leading portfolio of best-in-class molecular diagnostic and research products, including genetic screening and oncology testing kits, molecular controls, a Good Manufacturing Practice (GMP)-compliant 50,000 square foot manufacturing facility and a CLIA-certified laboratory, plus a team with deep expertise navigating products through the global diagnostic regulatory environment."

"Bio-Techne Corporation...today announced that Exosome Diagnostics, a Bio-Techne brand, has completed its clinical validation of an in vitro diagnostic (IVD) version of the ExoDx™ Prostate test (EPI) kit enabling self-certification as CE-IVD as of March 22, 2021."

"Bio-Techne Corporation…today announced it has reached an agreement to acquire Asuragen, Inc. for initial consideration of $215 million in cash plus contingent consideration of up to $105 million upon the achievement of certain future milestones. The transaction will be financed through a combination of cash on hand and an existing revolving line of credit. Bio-Techne anticipates the acquisition to close in the fourth quarter of its fiscal 2021…Asuragen brings a leading portfolio of best-in-class molecular diagnostic and research products, including its…Quantitidex qPCR® IS BCR-ABL kit to enable the monitoring of leukemia patients for minimal residual disease."

"Bio-Techne Corporation...today announced that Humana has awarded a contract effective April 1, 2021 to its Exosome Diagnostics laboratory, covering the ExoDx™ Prostate (EPI) test for men. Humana is the nation's largest Medicare Advantage provider serving an estimated 20 million patients in the United States...'This coverage decision will expand access to this test, enabling additional men to make more informed decisions on whether to defer or proceed with a prostate biopsy. The benefits of this test are increasingly resonating with both patients and payors and we look forward to continuing to scale this game-changing technology.'"

"Bio-Techne Corporation...today announced an important publication in BMC Urology, entitled A urine-based Exosomal gene expression test stratifies risk of high-grade prostate Cancer in men with prior negative prostate biopsy undergoing repeat biopsy...The EPI test yielded a negative predictive value (NPV) of 92% independent of other clinical features and would have avoided 27% of unnecessary prostate biopsies in men while missing only five patients with HGPCa (2.1%)."

"Bio-Techne Corporation…and QIAGEN N.V. today announced the expansion and extension of a non-exclusive partnership to co-market exosome technology to existing and potential biopharma partners as well as the joint development of new exosome based products. The agreement grants QIAGEN a non-exclusive development license to Bio-Techne's exosome technology for the development of companion in vitro diagnostic products (CDX-IVD) for existing and potential biopharma partners…The two companies also announced the extension and expansion of the existing exclusive collaboration and license agreement that was originally in place between Exosome Diagnostics (now a Bio-Techne company) and QIAGEN."

"Bio-Techne Corporation…today announced that Exosome Diagnostics…has established a new partnership with Hall of Famer and baseball's all-time ‘Iron Man’, Cal Ripken Jr...Today Ripken, 60, is leading a national effort with Exosome Diagnostics to build education and awareness of the ExoDx ™ Prostate test, encourage men to proactively take action and be aware of their prostate health. The ExoDx™ Prostate (EPI) test played an important role in the management of Cal's prostate cancer."

"Bio-Techne…and NanoString Technologies, Inc…today announced an expansion of their partnership to include compatibility with ACD's 21,000+ RNAscope probes and 10 qualified RNAscope probe combinations with GeoMx® Digital Spatial Profiler (DSP) and the recently launched GeoMx Cancer Transcriptome Atlas (CTA)."