Myriad Genetics announced that the US Food and Drug Administration (FDA) has accepted its supplementary premarket approval (sPMA) application for BRACAnalysis CDx to be used as a companion diagnostic with Pfizer’s PARP (poly ADP ribose polymerase) inhibitor, talazoparib. The New Drug Application (NDA) for talazoparib has been granted priority review by the U.S. Food and Drug Administration and has a Prescription Drug User Fee Act (PDUFA) goal date of December 2018.
Innosieve Diagnostics and Lonza Pharma & Biotech announced an exclusive distribution agreement for rapid bioburden testing technology. Under the agreement, Lonza will sell and distribute Innosieve Diagnostics’ MuScan Instrument, Sieve-ID Total Viable Count Kit, and associated software to the pharmaceutical, biotechnology, and medical device manufacturing industries. Control of bioburden during the manufacturing process is a regulatory requirement for the manufacture of drugs and medical devices. Bioburden testing is performed to assure that the bioburden remains low; however, a major challenge with conventional, growth-based bioburden testing is the lengthy time to results. Innosieve’s MuScan Instrument and Sieve-ID Total Viable Count Kit offer a non-growth-based bioburden testing approach that enables a single sample to be analyzed within one hour from collection; and up to six samples can be analyzed within two hours. The technology employs solid-state cytometry to detect stained microorganisms that are captured on the patented Sieve-ID filter. Innosieve’s new 21 CFR Part 11-compliant software then determines the number of viable cells present and records the results in an easy-to-read and auditable report.
Researchers at Exact Sciences and Mayo Clinic announced significant progress toward developing a panel of novel, blood-based, DNA biomarkers that could accurately detect hepatocellular carcinoma (HCC), the most common cancer that originates in the liver. The biomarker panel was shown to be 95% sensitive for detecting HCC across all stages. Sensitivity among patients with curable-stage disease was 91%. The panel has overall specificity of 93%, demonstrating its ability to discriminate between normal and diseased patients. Sensitivity and specificity are the most important statistical measures of a cancer detection test's performance. "These results are further validation of our advanced DNA technology and our multi-biomarker approach for the detection of the deadliest forms of cancer," said Kevin Conroy, chairman and CEO of Exact Sciences, in a press release. "We look forward to advancing this important research in early stage cancer with Mayo Clinic."
Karius announced expanded bacterial and fungal coverage for its quantitative next-generation sequencing (NGS) plasma test for pathogen detection today. The Karius Test has been expanded by 70 microorganisms, now detecting 1,320 pathogens from one blood draw with next day results. The test provides broad-based detection of clinically relevant pathogens, including more than 750 species of bacteria, over 100 DNA viruses and more than 300 fungi and molds. Currently available to hospitals across the United States, the Karius Test reports the presence and abundance of microbial cfDNA. The test provides clinicians with a report of the amount of pathogen DNA found in a patient’s blood as compared to a reference range from asymptomatic adults, providing additional insights regarding the burden of infection given the clinical context. “We are helping infectious disease doctors and microbiologists identify some of their most challenging infections, particularly where current diagnostic methods are either limited, invasive or time-consuming,” said David Hong, Karius Vice President of Medical Affairs and Clinical Development, in a press release. “In my experience as a pediatric infectious disease physician, some of the most challenging clinical scenarios I encounter include invasive fungal infections in immunocompromised patients. Next-generation sequencing of cell-free plasma can rapidly and non-invasively identify fungal pathogens in immunocompromised pediatric patients, allowing for earlier, targeted treatment.”
Curetis announced the US commercial launch of its Unyvero sample-to-answer molecular diagnostic system and the Unyvero LRT Application Cartridge for lower respiratory tract infections at the ASM Microbe 2018 Congress in Atlanta, GA, USA. Curetis obtained regulatory clearance for the Unyvero System and Unyvero LRT from the US FDA in April this year. The Unyvero System, together with the Unyvero LRT Application Cartridge, provides rapid infectious disease testing directly from aspirate samples in less than five hours. It covers more than 90% of infection cases of hospitalized pneumonia patients and provides clinicians with a comprehensive overview of genetic antibiotic resistance markers detected. As the first-in-class molecular test for lower respiratory tract infections with no direct molecular diagnostic competition, it addresses a significant unmet medical need that causes over $10bn in annual costs for the US healthcare system. It is also the first time that the US FDA has granted clearance for an automated molecular diagnostic test for the atypical microorganism Legionella pneumoniae.
Qure.ai announced that its chest x-ray product, qXR has received CE certification. Trained on more than one million chest x-rays, qXR detects 15 of the most common chest x-ray abnormalities with an accuracy of more than 90%. Taking only milliseconds to run, the product uses a heat map or bounding box to point out abnormalities to the clinician, facilitating rapid confirmation. In settings without trained healthcare professionals, qXR is already being used to screen for tuberculosis, proving a valuable supplement to the existing healthcare systems. There are fewer than five companies globally who have received a CE certification for AI-based radiology products. "The chest x-ray is the most commonly-performed radiology investigation, but one of the toughest to interpret," Shalini Govil, Quality Controller for the Columbia Asia Radiology Group, said in an official statement. "Qure.ai's solution could serve as a radiology assistant, providing a draft report that can be validated by a physician or radiologist. They've also come up with technology to visualize what the algorithm sees - a way to 'see through the computer's eyes.' I think this will be a game-changer on the road to building confidence in AI."
Elucidata announced that it has raised $1.7 million in seed funding. The financing round was led by Hyperplane Venture Capital along with several prominent angels. Elucidata’s tools allow drug discovery scientists to analyze complex datasets and effectively enable drug discovery. Polly, the company’s cloud-based data analytics platform, can drastically transform the end-to-end drug discovery process and allow for more rapid data turnaround and analysis. Elucidata’s novel metabolomics platform, released in 2018, is an extendable platform that can easily adapt to many types of data workflows and features an array of applications that can process, analyze, integrate, and visualize biological data across metabolomics, genomics, transcriptomics, and proteomics, among others. “The way biological data is used to drive discovery in the industry is often slow and cumbersome,” said Elucidata co-founder Abhishek Jha in a press release. “Our mission is to address the needs of all the very talented scientists who are discovering new life-saving drugs. They are sitting on very exciting datasets but are still manually crunching through spreadsheets to analyze vast amounts of data,” Jha adds. His experience at Agios Pharmaceuticals as an early member, Jha believes, has shaped his outlook of how data science can drive drug discovery. “Data generation has been modernized; data analysis is lagging. Elucidata aims to bridge this gap and ultimately impact human lives in profound ways.”
FamilyWize announced a partnership with MedTek21 that will give the public greater access to personalized medicine, helping patients better understand how their unique genetic profiles can influence how they metabolize certain medications. FamilyWize and MedTek21 can help patients by offering access to MedTek21 Direct, an easy-to-use personalized medication management program. This program can help patients learn if they have been prescribed a medication that might be impacted by their unique metabolic profile. MedTek21’s software and mobile application continuously keep patients and their physicians up to date and proactively flag any new potential issues in real time. Should a prescribed medication be indicated to not improve the patient’s health, this means money is being spent on a potentially ineffective prescription with each monthly refill. The partnership potentially enables consumers to experience positive results both physically and financially. The patient’s care providers can easily interpret MedTek21 Direct results to increase the efficiency of drug therapy through adjustments in the medication or medication dosages. In addition, patients can save significantly on the safest and most effective medications through FamilyWize and avoid the need to waste time and money on potentially ineffective medications.
