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BioIVT, Illumina, Certara, And More: News From November 2018

November 28, 2018 | November featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including BioIVT, Illumina, Certara, and more.

BioIVT announced that it has acquired Biological Specialty Corporation (BSC), a supplier of human blood products and components to the life sciences research community for more than 37 years. BSC is headquartered in Colmar, PA, with two additional FDA-registered donor centers in Allentown, PA and Reading, PA. “We are delighted that BSC is joining BioIVT,” said BioIVT Chief Executive Officer (CEO) Jeff Gatz in a press release. “BSC brings a decades-long reputation for top-notch quality, compliance and customer service. BSC’s capabilities will enable BioIVT to provide same-day fresh material to the biotech industry in the Northeast Corridor. BSC also significantly strengthens BioIVT’s immunology business line, enabling BioIVT to provide a full range of blood-derived cells and cellular products ranging from leukopak-derived peripheral blood mononuclear cells (PBMCs) to CD34 stem cells.” BioIVT will retain BSC’s three locations and all of its employees. Financial details about this transaction were not disclosed. Press release

Certara announced that it has been awarded two new dermal virtual bioequivalence grants by the US Food and Drug Administration (FDA). Bioequivalence studies are vitally important to ensure that the absorption rate and extent of test drug products are not significantly different to that of the comparable reference drug products. They are also used to verify that changes in manufacturing site, raw material suppliers or minor adjustments to a drug’s formulation do not substantially change its in vivo performance. “We are delighted to receive additional US FDA support for the continuing development of our dermal physiologically-based pharmacokinetic (PBPK) modeling and simulation program to conduct virtual bioequivalence studies. Virtual bioequivalence represents an ideal application for Simcyp’s PBPK modeling and simulation capabilities. In addition to providing additional insight into drug performance, these in silico studies are safer, faster and less expensive to conduct than clinical bioequivalence studies. As a result, these new grants represent an important advance for generic and innovator drug companies alike. We look forward to partnering with the US FDA to advance this field,” said Certara’s Simcyp President and Managing Director Steve Toon, in a press release. Certara’s Simcyp Division will lead the project entitled “Characterize Skin Physiology Parameters Utilized in Dermal PBPK Model Development Across Different Skin Disease States.” This grant will fund enhancements to Certara’s PBPK multi-phase, multi-layer (MPML) MechDermA skin model to include the quantitative description of disease-triggered histological and functional modifications to the skin. The resulting models will be able to factor in the thickness of various skin layers, presence of cracks, dryness, modification of blood flow and skin temperature, sebaceous gland infection and inflammation, flaking, and the presence of pustules, comedones, vacuoles, cysts, and pseudocysts. Histopathological modifications to Simcyp’s healthy skin model will permit development of models for specific skin diseases. The resulting disease models will all be verified using clinical data from the literature. Certara will also partner with Professor Michael Roberts, an Australian National Health & Medical Research Council Senior Principal Research Fellow and a professor at The University of Queensland and at The University of South Australia, and his team on their project to determine “Formulation Drug Product Quality Attributes in Dermal PBPK Models for Topical Dermatological Drug Products and Transdermal Delivery Systems.” Press release

Thermo Fisher Scientific has released the most comprehensive database of pre-designed and chemically modified long non-coding RNA siRNAs. Invitrogen Silencer Select lncRNA siRNAs provide a comprehensive library of more than 5,000 long non-coding RNA (lncRNA) targets. LncRNAs have been shown to regulate cell functions and knockdown of lncRNAs with small interfering RNA (siRNA) is a useful technique to determine the function and significance of individual lncRNA. New Silencer Select IncRNAs siRNAs offer up to 90% knockdown of lncRNA. The extensive library provides insight into how lncRNA regulates cell signaling, tumor progression and metabolic regulation. With double the lncRNA targets compared to other products on the market, the Silencer Select enables researcher to more efficiently conduct discovery work. Cells targeted with this product also retain high cell viability post-siRNA transfection. Press release

RPS announced an updated CE mark of its FebriDx test, clearing the way for its immediate launch in the European Union and all countries recognizing the CE mark. FebriDx is a rapid, accurate, and simple to use point-of-care test that is expected to contribute towards a diagnostic solution to the global antibiotic crisis. FebriDx provides clinicians with a 10-minute assessment of the body’s immune response to an acute respiratory infection (ARI) directly from a fingerstick blood sample. The single use, disposable test identifies patients who have a clinically significant underlying infection and aids in the differentiation of viral and bacterial ARIs through the rapid detection of both Myxovirus resistance protein A (MxA) and C-reactive protein (CRP). MxA is an intracellular protein that becomes elevated in the presence of acute viral infection and CRP is a nonspecific inflammatory protein that is elevated in the presence of any clinically significant infection. Thus, unlike a standalone CRP test, MxA confers specificity to the test through the combined interpretation of the results. The updated FebriDx test incorporates an all-in-one plastic housing technology that includes a built-in safety lancet, blood collection and delivery system, and integrated push button buffer delivery feature, which together, improve test convenience. The FebriDx test requires no additional equipment to perform or to interpret results. Through comprehensive analytical testing as well as a multicenter precision and reproducibility study, RPS Diagnostics successfully demonstrated equivalency to the previously CE marked version of the product. The timely FebriDx test results provide clinicians the ability to formulate a targeted clinical management and therapeutic decision plan during the initial patient encounter. Antibiotic misuse is a complex global problem that leads to antibiotic resistance, avoidable adverse events, and contributes to rising healthcare costs, largely driven by diagnostic uncertainty and patient pressure. More than 50% of all antibiotic prescriptions are unnecessary and are generated in the outpatient primary and urgent care setting. In a recent study in the United Kingdom, FebriDx was shown to alter clinical management decisions in 48% of patients tested, and to reduce unnecessary antibiotic prescriptions by 80%. Each day that goes by without the implementation of a cost effective solution is exacerbating the current global antibiotic crisis. Press release

Illumina announced the launch of TruSight Oncology 500 (TSO 500), a comprehensive pan-cancer assay designed to identify known and emerging tumor biomarkers. TruSight Oncology 500 utilizes both DNA and RNA from subject tumor samples to identify key somatic variants underlying tumor progression, such as small DNA variants, fusions, and splice variants. Importantly, TruSight Oncology 500 can measure tumor mutational burden (TMB) and microsatellite instability (MSI), features that are potentially key biomarkers for emerging immunotherapies. TruSight Oncology 500 is for research use only and will ship in Q1 2019. Molecular testing in lung cancer has been at the forefront of precision oncology. The use of targeted therapies is associated with improved outcomes in some patients, and currently requires testing multiple biomarkers, such as EGFR mutations, ALK fusions, and ROS fusions, among others. Recently, TMB gained prominence as a biomarker that demonstrates better response and survival from immune checkpoint inhibitors in patients exhibiting high TMB, necessitating the need for comprehensive sequencing. Reliable measurement of TMB in a tumor-only workflow requires sequencing of approximately 1Mb or greater, specific and sensitive variant calling, as well as bioinformatic methods to flag and remove germline variants. Given the increasing number of biomarkers required to fully understand the optimal therapeutic course, assays like TruSight Oncology 500—one of the largest and most comprehensive panels to-date—encompasses all of these biomarkers, making it an ideal choice for cancer researchers today. Press release

BD (Becton, Dickinson and Company) announced the US Food and Drug Administration 510(k) clearance of the BD Phoenix CPO detect test, which will allow hospitals to identify infections caused by carbapenemase-producing organisms (CPOs). The test may help hospitals contain the spread of antimicrobial resistance (AMR) by shortening the time it takes to detect CPOs, thereby enabling the earlier implementation of infection control procedures and the initiation of appropriate antibiotic therapies designed for treating these infections. According to the Centers for Disease Control and Prevention (CDC), CPOs, specifically Carbapenem-resistant Enterobacteriaceae (CRE), represent a prominent AMR threat to public health because these dangerous microbes are often resistant to nearly all available antibiotics. These organisms are also on the World Health Organization (WHO) priority pathogen list as critical threats to public health. Reported rates of mortality associated with certain CPO infections vary widely, from 22% to 72%. Once identified, rapid implementation of infection prevention measures are needed to prevent further transmission of these organisms and for appropriate patient management. The BD Phoenix CPO detect test, currently available in two configurations as part of the BD Phoenix automated microbiology system, detects CPOs and depending on configuration, can provide the Ambler classification of the enzyme produced to help inform clinicians in appropriate therapy selection. The test is included on BD Phoenix gram-negative panels, allowing hospital labs to offer it as part of routine antibiotic susceptibility testing. Press release

 SoftGenetics has announced the addition of a new analysis function in its GeneMarker software for the analysis of simple sequence repeats, which are responsible for over 40 human diseases. Developed in collaboration with leading researchers - including Pamela Snyder (Ohio State University), Ty Lynnes (Indiana School of Medicine), and Michelle Axford (North York Hospital) - the new GeneMarker application, called Sequence Repeat Expansion Analysis, eliminates the need to transfer data from genotyping software to a spreadsheet. In doing so, the function eliminates a source of error while also increasing analysis speed by performing the necessary calculations. The Sequence Repeat Expansion Application in GeneMarker software performs repetitive calculations by converting fragment size to repeat length. Highlights of the new application include: analysis parameters and report format are easily customized to fit the SOP for the laboratory; mobility coefficients are automatically calculated from controls or may be added by the analyst; and reporting options include .xls and .txt files of result tables as well as .pdf, .png, .jpg (.jpeg) image files of individual sample reports, and project summary reports. All in all, the new Sequence Repeat Expansion Application provides a user-friendly tool to streamline data analysis, customizable templates for different chemistries, and reporting flexibility. It provides the versatility needed to establish analysis templates and customized reporting for the many different disorders cause by DNA repeat expansions. Release

CareDx announced the pricing of an underwritten public offering of 2,000,000 shares of its common stock at a public offering price of $24.50 per share. The gross proceeds to CareDx from this offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be $49.0 million. In addition, CareDx has granted the underwriters a 30 day option to purchase up to an additional 300,000 shares of its common stock. The offering is expected to close on or about November 16, 2018, subject to the satisfaction of customary closing conditions. Jefferies and Piper Jaffray are acting as joint book-running managers for the offering. Craig-Hallum is acting as co-manager for the offering. Press release