Stanford University v. Roche Molecular Systems, Inc.

QIAGEN launches monkeypox test for NeuMoDx platform to fight global outbreak by boosting research and surveillance

Retrieved on: 
Montag, November 21, 2022
Biotechnology, Telemedicine, Virtual Medicine, Pharmaceutical, Health, Medical Devices, Infectious Diseases, Hospitals, Other Health, Blood, Molecular diagnostics, Automation, Senior, World Health Organization, WHO, Knowledge, QGEN, Infection, PCR, Patient, DNA, MOVEit, NYSE, Organic acid, Stanford University v. Roche Molecular Systems, Inc., Life, Real-time polymerase chain reaction, Research, Monkeypox, IVD, Protein, Growth, RNA, QIAGEN, RUO, Pharmaceutical industry, Vaccine, Pharma, Insight

The NeuMoDx MPXV Test Strip currently for research use only (RUO) is a multiplex test that identifies both clades (variants) of monkeypox.

Key Points: 
  • The NeuMoDx MPXV Test Strip currently for research use only (RUO) is a multiplex test that identifies both clades (variants) of monkeypox.
  • The NeuMoDx assay extracts DNA from lesion fluid swabs to isolate the target nucleic acids and then conducts a real-time polymerase chain reaction.
  • QIAGEN has been working with healthcare authorities around the world since the global monkeypox outbreak began this spring to contribute its broad testing portfolio and expertise as a trusted partner in an urgent global health response.
  • QIAGEN this summer launched the QIAstat-Dx Viral Vesicular Panel RUO, the worlds first syndromic test, for research use only, to differentiate between monkeypox and five other pathogens that cause similar symptoms.

QIAGEN Adds New Assays With CE-IVD Certification for NeuMoDx Integrated PCR System

Retrieved on: 
Donnerstag, September 15, 2022
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Infectious Diseases, Clinical Trials, Chlamydia trachomatis, Molecular diagnostics, QIAGEN, Real-time polymerase chain reaction, Knowledge, COVID-19, NYSE, Risk, Organic acid, Blood, QGEN, Severe acute respiratory syndrome coronavirus 2, U.S. Securities and Exchange Commission, Life, Growth, Monkeypox, EU, Patient, RSV, Certification, Viral load, Reproductive health, Stanford University v. Roche Molecular Systems, Inc., Protein, Immunodeficiency, Solution, HPV, RNA, Research, DNA, Urine, Automation, EBV, SEC, Union, Mortality, Budget, Organ transplantation, Vaccine, Insight, Academy, Chlamydia, Pharma

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced new additions to its comprehensive NeuMoDx assay menu for organ transplant-associated viruses.

Key Points: 
  • QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced new additions to its comprehensive NeuMoDx assay menu for organ transplant-associated viruses.
  • The new assays support QIAGENs strategy of expanding the menu of tests available for use on the NeuMoDx 96 and 288 Molecular Systems.
  • The assay adds to the broad portfolio that QIAGEN offers to address all testing needs around monkeypox.
  • QIAGEN remains committed to responding to the COVID-19 endemic by preparing to launch a new multiple-target test: NeuMoDx FluA/FluB/RSV/SARS-CoV-2 Assay with a new dual-target SARS-CoV-2 design.

Oncology Molecular Diagnostics Global Market Research Report 2022: PCR, ISH, INNAT, Chips & Microarrays, Sequencing, Mass Spectroscopy, & TMA Analysis & Forecasts 2016-2021, 2021-2026F, 2031F - ResearchAndMarkets.com

Retrieved on: 
Dienstag, August 30, 2022
Genetics, Health, Oncology, Danaher Corporation, ICON plc, ISH, BD (company), EGFR, Breast cancer, Leica Biosystems, Cancer, Female, Immunohistochemistry, Polymerase chain reaction, Large-cell lung carcinoma, Hologic, Protein, Gen-Probe, Incidence, Cepheid variable, Blood, Beckman Coulter, Siemens Healthineers, Lung, American Cancer Society, Organization, Hospital, IHC, PCR, Saliva, FDA, Roche Diagnostics, Prostate, Mutation, ICON, Genomics, Acquisition, Growth, Health, TMA, Stanford University v. Roche Molecular Systems, Inc., Patient, Medical imaging, Cobas

Major players in the oncology molecular diagnostics market are Abbott Diagnostics, Becton Dickinson, Cepheid, Danaher Corporation, Beckman Coulter, Leica Biosystems, Gen-Probe (Hologic), Qiagen N.V., Roche Diagnostics, and Siemens Healthcare.

Key Points: 
  • Major players in the oncology molecular diagnostics market are Abbott Diagnostics, Becton Dickinson, Cepheid, Danaher Corporation, Beckman Coulter, Leica Biosystems, Gen-Probe (Hologic), Qiagen N.V., Roche Diagnostics, and Siemens Healthcare.
  • The high cost of molecular diagnostic tests is a key factor hampering the growth of the oncology molecular diagnostics market.
  • Therefore, the high cost of molecular diagnostic tests is expected to hamper the growth of the oncology molecular diagnostics market.
  • The countries covered in the oncology molecular diagnostics market are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, and USA.

QIAGEN Adds HSV1/2 Herpes Assay With CE-IVD Certification for Use on NeuMoDx Integrated PCR System

Retrieved on: 
Donnerstag, Mai 5, 2022
Biotechnology, Managed Care, Health, Pharmaceutical, Research, Infectious Diseases, Hospitals, Surgery, Genetics, Science, Clinical Trials, Sentinel, Organ transplantation, Non-functional testing, Budget, Reproductive health, Infection, SEC, Life, Solution, Immunodeficiency, Mortality, BKV, NYSE, Immunochemistry, Patient, Urine, Partnership, Automation, Chlamydia trachomatis, Knowledge, Organic acid, BK, Research, FOB, Stanford University v. Roche Molecular Systems, Inc., Clinical chemistry, BK virus, Epstein–Barr virus, U.S. Securities and Exchange Commission, Union, RNA, Bandini s.p. 1000, QIAGEN, RSV, Genome, Cytomegalovirus, HBV, QGEN, Certification, Viral load, HCV, DNA, Urinary tract infection, Severe acute respiratory syndrome coronavirus 2, Protein, Growth, EBV, Influenza, Real-time polymerase chain reaction, HIV, Blood, Colorectal cancer, Molecular diagnostics, HPV, HSV, CMV, Vaccine, Medical device, Academy, Insight, Pharma, Chlamydia

The availability of the NeuMoDx HSV 1/2 Quant Assay also strengthens the comprehensive menu of transplant assays.

Key Points: 
  • The availability of the NeuMoDx HSV 1/2 Quant Assay also strengthens the comprehensive menu of transplant assays.
  • Despite major advances in organ transplantation over the past four decades, herpesvirus infections remain a major cause of post-operative mortality.
  • Aside from assays for post-transplant monitoring the NeuMoDx solutions currently offer CE-IVD tests for detection and quantitation of blood-borne viruses (HIV, HCV, and HBV).
  • For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).

Delfi Diagnostics Adds Reimbursement, Regulatory Leaders to Management Team

Retrieved on: 
Donnerstag, März 24, 2022
Adoption, DNA, Leadership, Quality assurance, Multimedia, Health policy, Delfi, BIO, Stanford University v. Roche Molecular Systems, Inc., Quality management, Government, Cancer, NextGen Healthcare, Compliance, Roche, Biotechnology Innovation Organization, Technology, Machine learning, Policy, ACLA, Solution, Patient, Roche Diagnostics, Algorithm, Management, Fine chemical, Quality, Regulation

BALTIMORE, March 24, 2022 /PRNewswire/ -- Delfi Diagnostics, a pioneering developer of a new class of high-performance, affordable liquid biopsy tests for early cancer detection, added two new leaders to its management team to oversee regulatory, policy, and reimbursement activities as the company advances its products toward commercialization.

Key Points: 
  • BALTIMORE, March 24, 2022 /PRNewswire/ -- Delfi Diagnostics, a pioneering developer of a new class of high-performance, affordable liquid biopsy tests for early cancer detection, added two new leaders to its management team to oversee regulatory, policy, and reimbursement activities as the company advances its products toward commercialization.
  • Michaela Hart has joined as Delfi's Vice President of Regulatory, Quality and Lab Operations, and Paul Sheives has joined as Vice President of Government Relations and Reimbursement.
  • "Michaela and Paul bring important regulatory and reimbursement leadership to the team we have been building for the last year at Delfi," said Jenn Buechel, Delfi's Chief Operation Officer.
  • Previously, she served as Vice President of Quality Management and Regulatory Affairs for Roche Sequencing USA, and also as Vice President of Molecular Operations and Quality Assurance for Veracyte.

Hardy Diagnostics Now Offers the BioCode® MDx-3000

Retrieved on: 
Montag, März 14, 2022
Federal Food, Drug, and Cosmetic Act, Gram, Partnership, NL63, Laboratory, RPP, OC43, STEC, Campylobacter, Hair, BMB, Emergency Use Authorization, Severe acute respiratory syndrome coronavirus 2, Bacteria, Stanford University v. Roche Molecular Systems, Inc., Hardy, Escherichia coli, Hardy Diagnostics, Allergy, FDA, EIEC, EUA, Infection, EAEC, GLOBE, Hematology, Autoimmune disease, LIS, Microbiology, ETEC, PCR, Automation, 1993 Jack in the Box E. coli outbreak, RSV, Vibrio parahaemolyticus, Culture, GPP, Immunochemistry, Nomenclature codes, IVD, Fungus, Medical degree, Molecular Probes, Yersinia enterocolitica, Virus, COVID, HKU1, Laboratory information management system, CE marking, Hospital, Technology, COVID-19, Diagnosis, Vaccine, Medical device, Coronavirus

"Applied BioCode is thrilled to partner with Hardy Diagnostics," said Winston Ho, President of Applied BioCode.

Key Points: 
  • "Applied BioCode is thrilled to partner with Hardy Diagnostics," said Winston Ho, President of Applied BioCode.
  • "We look forward to working with the Hardy Diagnostics team to expand our reach in hospitals and reference laboratories in the US."
  • Hardy Diagnostics is an FDA-licensed manufacturer of medical devices for microbiology testing with an ISO 13485 certified Quality Management System.
  • Hardy Diagnostics distributes more than 13,000 products, services more than 10,000 laboratories and exports to more than 80 foreign distributors.

Applied BioCode Obtains Emergency Use Authorization for CoV-2 Flu Plus Assay

Retrieved on: 
Donnerstag, Dezember 16, 2021
Health, FDA, Medical Devices, Infectious Diseases, Research, Science, Biotechnology, RPP, Anxiety, BMB, Autoimmune disease, Solution, Degenerative disease, FDA, US, Allergy, Influenza, COVID-19 testing, Infection, Severe acute respiratory syndrome coronavirus 2, Physician, Diagnosis, Molecular Probes, Immunochemistry, IVD, COVID-19, Nomenclature codes, Emergency Use Authorization, EUA, CE marking, Hair, Patient, Stanford University v. Roche Molecular Systems, Inc., Laboratory, Virus, Urinary tract infection, RSV, GPP, Medical degree, View, Vaccine, Medical device, H3

Applied BioCode announced today that it has received Emergency Use Authorization (EUA) from the US FDA for its BioCode CoV-2 Flu Plus Assay.

Key Points: 
  • Applied BioCode announced today that it has received Emergency Use Authorization (EUA) from the US FDA for its BioCode CoV-2 Flu Plus Assay.
  • The BioCode CoV-2 Flu Plus Assay is Applied BioCodes third EUA authorization from the US FDA for COVID-19 testing.
  • Applied BioCode previously received FDA EUA authorization for the BioCode SARS CoV-2 Assay and for pooling of up to 5 samples for that assay.
  • BioCode CoV-2 Flu Plus Assay builds on the existing portfolio of high-throughput syndromic assays from Applied BioCode including the FDA 510(k) cleared BioCode Respiratory Pathogen Panel (17 targets), FDA 510(k) cleared BioCode Gastrointestinal Pathogen Panel (17 targets), and its stand-alone EUA authorized BioCode SARS-CoV-2 Assay.

Global $9.56 Bn Oncology Molecular Diagnostics Markets, Analysis & Forecasts, 2015-2020, 2020-2025F, 2030F - ResearchAndMarkets.com

Retrieved on: 
Montag, Dezember 13, 2021
Health, Oncology, American Cancer Society, Leica Biosystems, Organization, Roche Diagnostics, Gen-Probe, FDA, Protein, Genomics, Cancer, Stanford University v. Roche Molecular Systems, Inc., Growth, Technology, Incidence, EGFR, COVID-19, Female, Breast cancer, Beckman Coulter, Saliva, Lung, Prostate, Siemens Healthineers, BD (company), Patient, Danaher Corporation, Mutation, Blood, Cepheid variable, Hologic, Health, Large-cell lung carcinoma, Medical imaging, Cobas

The high cost of molecular diagnostic tests is a key factor hampering the growth of the oncology molecular diagnostics market.

Key Points: 
  • The high cost of molecular diagnostic tests is a key factor hampering the growth of the oncology molecular diagnostics market.
  • Therefore, the high cost of molecular diagnostic tests is expected to hamper the growth of the oncology molecular diagnostics market.
  • Global Oncology Molecular Diagnostics Market, Segmentation by Product, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion
    6.2.
  • Global Oncology Molecular Diagnostics Market, Segmentation by Technology, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion

Roche launches the first infectious disease tests and cobas omni Utility Channel for use on the cobas 5800 System in countries accepting the CE Mark

Retrieved on: 
Mittwoch, Dezember 15, 2021
DJSI, Roche Diagnostics, Hoffmann-La Roche, RNA, Genentech, PCR, Molecule, HIV-1, Essential medicines, Severe acute respiratory syndrome coronavirus 2, LDT, Diagnosis, Utility, Automation, Genome, Stanford University v. Roche Molecular Systems, Inc., World, IVD, LIS, Time, HIV, Plasma, Serum, Dow Jones, RO, Dried blood spot, Patient, HBV, Infection, Laboratory, CE, Joint Medical Service (Germany), HIV-2, Cobas, Ophthalmology, HCV, Central nervous system, CHF, ROG, Fine chemical, Medical imaging, Vaccine, Chugai Pharmaceutical Co., System

The cobas 5800 System will offer the same menu as the cobas 6800 and 8800 Systems.

Key Points: 
  • The cobas 5800 System will offer the same menu as the cobas 6800 and 8800 Systems.
  • Roche is pursuing CE approval for continued menu expansion on the cobas 5800 System, including cobas SARS-CoV-2, through early-to-mid 2022.
  • Roche anticipates tests to be available beyond CE markets in additional countries in 2022.
  • The cobas omni Utility Channel on the cobas 5800 System enables a broader testing menu by consolidating open channel assays with Roche in vitro diagnostic (IVD) assays on a single platform.

Roche launches the first infectious disease tests and cobas omni Utility Channel for use on the cobas 5800 System in countries accepting the CE Mark

Retrieved on: 
Mittwoch, Dezember 15, 2021
DJSI, Hepatitis B, Roche Diagnostics, Hoffmann-La Roche, RNA, Genentech, PCR, Death, Molecule, HIV-1, Essential medicines, Severe acute respiratory syndrome coronavirus 2, LDT, Infection, Diagnosis, Utility, Automation, Genome, Stanford University v. Roche Molecular Systems, Inc., World, Running, IVD, LIS, Time, HIV, Plasma, Serum, Dow Jones, RO, Dried blood spot, Patient, HBV, Laboratory, CE, Joint Medical Service (Germany), HIV-2, Cobas, Ophthalmology, HCV, Central nervous system, CHF, ROG, Vaccine, Fine chemical, Medical imaging, Chugai Pharmaceutical Co., System

PLEASANTON, Calif., Dec. 15, 2021 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the first infectious disease tests on the cobas® 5800 System, a new molecular laboratory instrument, in countries accepting the CE mark. These include cobas® HIV-1, cobas® HBV, cobas® HCV, cobas® HIV-1/HIV-2 Qualitative, and the cobas omni Utility Channel kit. These launches expand the Roche Molecular portfolio offering by providing standardised performance and efficiencies across low, medium and high volume molecular laboratory testing needs.

Key Points: 
  • PLEASANTON, Calif., Dec. 15, 2021 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the first infectious disease tests on the cobas 5800 System, a new molecular laboratory instrument, in countries accepting the CE mark.These include cobas HIV-1, cobas HBV, cobas HCV, cobas HIV-1/HIV-2 Qualitative, and the cobas omni Utility Channel kit.
  • The cobas 5800 System will offer the same menu as the cobas 6800 and 8800 Systems.
  • Roche is pursuing CE approval for continued menu expansion on the cobas 5800 System, including cobas SARS-CoV-2, through early-to-mid 2022.
  • The cobas omni Utility Channel on the cobas 5800 System enables a broader testing menu by consolidating open channel assays with Roche in vitro diagnostic (IVD) assays on a single platform.