Weekly Cover: Eisai to Launch “NouKNOWTM” in Japan for Regular Self-assessment of Brain Health
By Ching-Hsu Yang, Donna Lee
1. Eisai To Launch “NouKNOWTM” in Japan for Regular Self-assessment of Brain Health
On March 23, 2020, Eisai Co., Ltd. revealed the introduction of “NouKNOWTM”, a modern automated non-medical tool for brain function self-assessment.
The product was wholly developed by Eisai using “Cogstate Brief BatteryTM” (CBB), a cognitive function test created by Australia-based cognitive science company Cogstate, Ltd..
The project would, initially, concern legal organizations such as governments and companies.
“NouKNOW” is performed by means of a standardized card check using a PC or tablet computer to quantitatively assess brain output in four experiments measuring psychomotor control, concentration, understanding and memory, and working memory.
Eisai Co., Ltd. is the world’s largest pharmacy research and manufacturing firm based in Japan. The company positions oncology as a main field of study and aims to create innovative novel cancer drugs.
2. QuarkBio Develops a COVID-19 Test Kit, 10 Times More Sensitive than Existing Kits
On March 19, 2020, Quark Biosciences Inc. announced it had successfully developed a novel digital PCR test, DigiChip SARS-CoV-2 Assay, that is 10x more sensitive than conventional diagnostic methods.
The DigiChip SARS-CoV-2 Assay utilizes QuarkBio’s proprietary dqPCR platform and high-density gene chip, which can simultaneously perform absolute quantification (digital PCR – dPCR) and real-time quantitative analysis in the same reaction, thus increasing both sensitivity and accuracy. The technology platform can analyze 6 samples concurrently, obtaining clinical results in less than 90 minutes. In addition, the assay is capable of detecting minute amounts of virus presence, allowing for identification of patients at the early stages of infection and reducing false-negative results, which is an important leverage when working to contain the spread of the virus.
Quark Biosciences plans to work with Shin Kong Memorial Hospital and a California-based medical group to launch clinical trials and apply for regulatory approval for the test kit.
QuarkBio is a Taiwan-based company that aims to develop innovative testing platforms and applications through in-house scientists and collaboration with external partners. Utilizing the PanelChip™ Operating System, QuarkBio works with partners to co-develop diagnostic assays and create ready-to-use products for partners.
3. EirGenix, Inc. Inks Supply Agreement With UBI Pharma Inc.
On March 19, 2020, the Hsinchu Science Park Bureau, Ministry of Science and Technology held a press conference to announce that EirGenix and UBI Pharma had designed a COVID-19 2-hour test.
UBI Pharma Inc. stated that when the severe acute respiratory syndrome (SARS) outbreak occurred in 2003, it used the Group’s synthetic peptide virus antibody detection reagent technology platform to design antibody detection reagents that can diagnose SARS virus infection within 4 months.
In response to the ongoing coronavirus outbreak, after 2 months of hard work, UBI Pharma Inc. has successfully developed antibody blood testing reagents, which have been approved by relevant US units for emergency use.
EirGenix is a contract development and manufacturing organization that offers high-, cost- services. The Company provides the development, analytical screening and current good manufacturing processes (cGMP) of biopharmaceuticals from pre-clinical to commercial output. EirGenix supports customers all over the globe.
About UBI Pharma Inc.
UBI Pharma Inc. was founded as a spin-off corporation from United Biomedical, Inc. Asia in September 2013, taking over the entire monoclonal antibody (mAb) pharmaceutical sector of UBI Asia, including drug rights, technology, R&D staff and manufacturing facilities. UBI Pharma Inc. focuses on the production, manufacture and distribution of advanced therapeutic mAb products and related technology.
4. NuProbe Announces Strategic Collaboration with QIAGEN Towards Multiple CE IVD Product Registration
Cambridge, Massachusetts-Headquartered NuProbe Global, a global molecular diagnostics company, have announced that it has entered into a collaboration agreement with QIAGEN, a world pioneer in Life Science Sample to Insight solutions, to develop next-generation sequencing (NGS)-based cancer diagnostic tests for non-invasive liquid biopsy.
Within the terms of the partnership deal, NuProbe and QIAGEN will discuss the convergence of their two amplicon-based amplification and sequencing technologies: the patented Blocker Displacement Amplification (BDA) technology of NuProbe and the Single Primer Extension (SPE) technology of QIAGEN, for precise and inexpensive detection of DNA mutations with very small allele fraction variants and for development of non-invasive DNA mutations.
About NuProbe Global
NuProbe is a cutting-edge genomics company formed through the merger of NuProbe and Carrier Gene. It is developing sequencing-based tests for cancer and infertility. NuProbe has sites in Shanghai and Suzhou, China and Houston, USA. NuProbe collaborates with renowned medical institutions including MD Anderson and Baylor College of Medicine. NuProbe’s revolutionary molecular diagnostics technologies greatly increase the sensitivity and affordability of qPCR, Sanger, and NGS, enabling broader adoption of personalized medicine.
QIAGEN provides Sample to Insight solutions for PCR / qPCR, next-generation sequencing and acceleration that empower our customers to accomplish outstanding achievements and advancements in life sciences.
5. Japan Approves Novartis’ SMA drug
On March 19, 2020, Novartis Pharma reported that Zolgensma® had been approved by the Japanese Ministry of Health, Labor and Welfare (MHLW) for the management of spinal muscular atrophy (SMA) in patients under the age of two, including those that are pre-symptomatic at diagnosis.
Zolgensma is a one-time gene therapy developed to treat the hereditary root cause of the disorder by restoring the role of the defective or non-working SMN1 gene.
About Spinal Muscular Atrophy
Spinal muscular atrophy (SMA) is a severe hereditary neuromuscular disorder caused by a loss of a functional SMN1 gene. SMA results in a sudden and lasting failure of motor neurons influencing muscle control, including chewing, swallowing and basic movement. Approximately 60% of all SMA is Type 1.
Novartis AG, a Swiss multinational pharmaceutical company based in Basel, Switzerland, manufactures pharmaceutical and consumer healthcare products, and is one of the largest pharmaceutical companies by both market capitalization and sales.
About the Drug
In May 2019, the U.S. Food and Drug Administration (FDA) approved Zolgensma for the treatment of pediatric patients less than two years of age with SMA with bi-allelic mutations in the SMN1 gene. Approximately 400 patients have been treated with Zolgensma, including clinical trials, commercially and through the managed access program in the U.S. In the U.S. nearly all on-label patients have been approved by their payer for access to Zolgensma. AveXis is pursuing registration in close to three dozen countries with a Committee for Medicinal Products for Human Use opinion expected in 1Q 2020 and regulatory decisions anticipated in Switzerland, Canada and Australia in late 2020 or early 2021
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