May 1, 2019 | April featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including QIAGEN, Charles River, AiLife Diagnostics, and more.
QIAGEN announced the US launch of its novel therascreenFGFR Kit as a companion diagnostic to help guide the use of the newly approved FGFR kinase inhibitor, BALVERSA (erdafitinib), developed by Janssen Biotech. The test will aid in identifying patients with urothelial cancer whose tumors have certain alterations in the fibroblast growth factor receptor 3 (FGFR3) gene. The US Food and Drug Administration co-approved the new test with BALVERSA, as announced today by Janssen. "We are very excited about the launch of the new therascreen FGFR Kit, the first companion diagnostic test to obtain FDA approval for detection of FGFR gene alterations to guide therapy in any cancer indication. Using our test to help guide treatment decisions in urothelial cancer will address a high unmet medical need among patients," Thierry Bernard, Senior Vice President and Head of QIAGEN's Molecular Diagnostics Business Area, said in a press release. "The new therascreen FGFR Kit and significant testing capacities at leading laboratories will be available through QIAGEN's Day-One Lab Readiness program to accelerate the availability of innovations in Precision Medicine." Press release
QIAGEN also announced a master service agreement with LabCorp to further accelerate the access of cancer patients to QIAGEN's companion diagnostic products following regulatory approvals of drugs and their associated tests. As a new participant in QIAGEN's Day-One Lab Readiness program, LabCorp will be able to provide physicians and patients with faster access to new, genomically targeted drugs that are becoming increasingly important therapies for a growing variety of cancers. LabCorp is the latest company to join the program, and its expertise in the commercial use of companion diagnostics will help a broader range of patients gain access to innovative tools for precision medicine. Building on the US Food and Drug Administration's modernized regulatory approach, QIAGEN's Day-One Lab Readiness program enables molecular diagnostic labs to begin implementing the activities necessary to prepare for commercial launch of new drugs and IVD tests once FDA approval is obtained. LabCorp's participation in QIAGEN's network of laboratory partners will contribute to ensuring testing readiness for a portfolio of new companion diagnostics, including tests based on next generation sequencing (NGS) and qualitative polymerase chain reaction (qPCR), being prepared for launches in 2019 and 2020 in several countries around the world. Press release
Charles River Laboratories and CHDI Foundation announced a five-year extension of their ongoing collaboration. The organizations began working together in 2005 on drug discovery and development for Huntington’s disease (HD), a genetic neurological disease that causes the progressive dysfunction of nerve cells in the brain. The extension will allow more flexible activity across the different Charles River platforms and entail greater integration into CHDI’s programs. The contract extension covers multidisciplinary services from across Charles River’s portfolio, including: integrated biology and chemistry capabilities; complex primary neuronal assay development; high-content and fragment-based screening; computational chemistry; absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetics (PK); protein crystallography; and extensive in vivo pharmacology approaches in research models for translational assessment. Press release
AiLife Diagnostics and BGI Americas announced that they have entered into an agreement to jointly develop and market a clinical whole genome sequencing (WGS) solution for diagnosis of genetic disorders. This test leverages BGI’s DNBseq next generation sequencing (NGS) technology and AiLife’s established A-GPS, I-GPS and D-GPS pipelines for clinical NGS data analysis, interpretation and reporting. The joint WGS testing solution will feature BGI’s proprietary DNBseq technology, which has already been widely and well-recognized by the research community. BGI started offering the $600 research-grade WGS service in 2018, enabling holistic assessment of genetic profiles at a cost level similar to whole exome sequencing (WES) and targeted sequencing. So far, over 100,000 WGS samples have been sequenced globally using DNBseq technology. Compared to conventional sequencing technology, BGI delivers better indel calling accuracy, better GC coverage, a higher mapping rate and lower duplication rate. More importantly, the cost advantage of DNBseq technology will undoubtedly enable future adoption of clinical WGS testing, which historically has not been widely accessible to patients and clinical providers due to the cost hurdle. Yaping Yang, CEO and founder of AiLife Diagnostics and visiting professor at Baylor College of Medicine, said in a press release, "This collaboration combines BGI’s expertise in high-throughput sequencing technologies and platforms and AiLife's expertise in clinical interpretation and research analysis of NGS data. We are very excited to have the opportunity to serve the community and help move genomic medicine forward." Press release
Gradientech announced it has closed a fully subscribed rights issue totaling $4.6 million. Existing owners, as well as new parties appointed by Erik Penser Bank AB, who acted as financial advisor, have subscribed. Bird & Bird Lawyers acted as legal advisors. Sara Thorslund, CEO of Gradientech said in a press release: "We have now successfully completed Gradientech's largest rights issue, which provides capital for continued development and early market introduction of our QuickMIC diagnostic system. Our system is significantly faster than existing laboratory techniques for antibiotic resistance testing of samples from sepsis patients. This is critically important for the sepsis patient, and also advantageous for the healthcare economy since the length of stay in hospital can be reduced. The implementation of our QuickMIC system can also reduce improper use of antibiotics, which is very import to combat the global increase in antibiotic resistance." New shareowners include a significant number of individuals with solid industrial experience from the diagnostics field, and also people experienced specifically within the area of antibiotic susceptibility testing. "We are particularly pleased that, in addition to new investment capital, people with very relevant business backgrounds and important networks have joined the ownership structure. I believe this will benefit the company's development strongly going forward," concludes Thorslund. Press release
OncoCell MDx announced the appointment of Mark McDonough as its president, chief executive officer (CEO) and member of the Board of Directors. McDonough succeeds company co-founder, investor and Chairman/CEO Harry Stylli. Stylli continues as the executive chairman of the company. "Since OncoCell's founding, we have built an outstanding research and development capability and advanced a proprietary platform that exploits the power of the immune system and machine learning to non-invasively identify robust disease signatures for many pathologies. Although the platform has the capability to target any analyte, we chose to exploit gene expression. To date we have analyzed about 2,000 patient samples to identify a unique immunogenomic signature that can discriminate subjects with indolent and aggressive prostate cancer from normal controls. With the presentation of promising results from our recent study at the American Association for Cancer Research Annual Meeting, we demonstrated the potential of our technology to aid in early detection and progression of disease pathology," Stylli said in a press release. "Mark has an outstanding track record in generating significant value at both large and small companies in the molecular diagnostics field and especially for companies like ours that are approaching commercialization," he added. "I'm excited that he will lead OncoCell MDx in our mission to bring novel technologies to market that help physicians better manage patients with prostate cancer and other pathologies." McDonough most recently served as the chief business officer at Phosphorus. Prior to joining Phosphorus, McDonough served as chief executive officer and president of CombiMatrix, a publicly held molecular diagnostics company performing DNA-based testing services for reproductive health and developmental disorders, through its acquisition by Invitae Corp. He also held executive and management positions with US LABS (acquired by LabCorp) and Ventana Medical Systems (acquired by Roche) as well as Pathwork Diagnostics. Press release
VisualDx announced it has been awarded a grant from the Translational Research Institute for Space Health(TRISH) at Baylor College of Medicine (BCM) to provide integrated clinical decision support for ultrasound imaging during deep space flight. TRISH has a cooperative agreement with the National Aeronautics and Space Administration (NASA). VisualDx was awarded a separate grant in August 2018 to conduct research related to artificial intelligence for point-of-care diagnostics during space travel as well. Spaceflight mission on-board medical diagnostic systems need to provide user-guidance capabilities or minimize training time by being exceptionally intuitive and easy to use. Therefore, using its proprietary technology, VisualDx was selected for the TRISH grant to create a stand-alone version of its platform that will allow for use with no required internet connection. VisualDx is well qualified to contextualize ultrasound imaging into the broader diagnostic evaluative process to enhance astronaut capability for self-directed medical care when telemedical help from Earth-based physicians is delayed or unavailable. "We understand the reality that imaging and diagnostic modalities are limited during deep space flight," said Art Papier, CEO of VisualDx, in a press release. "While astronauts may have PhDs, they aren't physicians, which is why we're thrilled to have been tapped by TRISH to provide integrated clinical decision support for ultrasound imaging during space flights." Press release
Ortho Clinical Diagnostics announced the launch of four new key assays to meet the demand of the rapidly growing diagnostics market in China. This product launch, in collaboration with Beijing Leadman Biochemistry, based in Beijing, expands Ortho's offerings for renal, liver and cardiac testing and adds the following assays that are central for improving the efficiency of STAT labs: Cystatin C, α-Hydroxybutyrate Dehydrogenase (HBDH), Homocysteine (HCY), and Total Bile Acid (TBA). "Ortho has a longstanding commitment to deliver the right menu that drives medical value for our customers," said Heidi Casaletto, head of clinical labs menu business field at Ortho, in a press release. "We're thrilled to collaborate with an innovative organization like Leadman to accelerate our presence in China, and most importantly, to offer a new portfolio of MPA assays that will help to make hospital STAT labs more flexible and efficient." Press release
Scipher Medicine is developing a diagnostic platform that predicts response to anti-TNF therapies for RA patients and more, to identify the most successful treatment for individual patients. If PrismRA was ordered before prescribing 100% of all anti-TNF drugs in the United States, it would double adequate drug response rates for RA patients from 35% up to 67%. Scipher Medicine’s proprietary map of human protein interactions can also help expedite the development of alternative treatments. Scipher's first tests require a small blood or tissue sample from the patient before they start a biologic like anti-TNF drugs. When the tests are commercially available, a physician will be able to order the test and the patient's sample is sent to our laboratory partner where the RNA is extracted and analyzed. The patient's RNA profile is compared on our protein interaction map to determine "responder" or "non-responder" to specific targeted drugs. The physician will receive the binary result within 7 business days. Site