Healthcare Sales & Marketing Network News: polymerase chain reaction

Searching News Database: polymerase chain reaction

HSMN NewsFeed - 20 Aug 2024
RYBREVANT(R) (amivantamab-vmjw) Plus LAZCLUZE(TM) (lazertinib) Approved in the U.S. as a First-line Chemotherapy-free Treatment for Patients with EGFR-mutated Advanced Lung Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 25 Jul 2024
BD, Quest Diagnostics Join Forces to Develop Companion Diagnostics for Cancer, Other Diseases
Diagnostics Oncology

HSMN NewsFeed - 26 Sep 2022
BD, CerTest Biotec Announce US Commercial Launch of Monkeypox Assay
Diagnostics Product Launch

HSMN NewsFeed - 25 May 2022
Alercell Starts to Distribute Human Papilloma Virus (HPV) DNA Test
Diagnostics Product Launch

HSMN NewsFeed - 4 May 2022
Abbott Obtains FDA Clearance for First Test that Simultaneously Detects Four Common Sexually Transmitted Infections (STIs) as Cases are on the Rise
Diagnostics FDA

HSMN NewsFeed - 17 Dec 2021
BD Expands Fully Automated High-Throughput Molecular Diagnostic Platform for Core Labs
Diagnostics Regulatory

HSMN NewsFeed - 30 Aug 2021
Visby Medical(TM) Receives FDA Clearance and CLIA Waiver at the Point of Care for PCR Sexual Health Test
Diagnostics FDA

HSMN NewsFeed - 9 Dec 2020
Mesa Biotech Receives 510(k) Clearance and CLIA Waiver for Its Accula(TM) Strep A Molecular Point of Care Test
Diagnostics FDA

HSMN NewsFeed - 29 Oct 2020
Roche receives FDA approval for the cobas EGFR Mutation Test v2 as the first companion diagnostic test for expanded EGFR TKI therapies in patients with non-small cell lung cancer
Diagnostics Oncology FDA

HSMN NewsFeed - 7 May 2020
OPTI Medical Systems Receives US FDA Emergency Use Authorization for Its OPTI SARS-CoV-2 RNA PCR Test Kit for Detection of the Virus Causing COVID-19
Diagnostics FDA

HSMN NewsFeed - 26 Mar 2020
Immunexpress Receives CE Mark and Signs European Commercialization Partnership for SeptiCyte(R) RAPID
Diagnostics Regulatory

HSMN NewsFeed - 17 Dec 2019
ArcherDX Announces Close of $55 Million Series C Financing
Diagnostics Venture Capital

HSMN NewsFeed - 17 Dec 2019
ChromaCode Raises $28 Million in Series C Financing
Diagnostics Venture Capital Personnel

HSMN NewsFeed - 27 Nov 2018
Mesa Biotech Receives FDA 510(k) Clearance and CLIA Waiver for Its Accula(TM) RSV Molecular Point of Care Test
Diagnostics FDA

HSMN NewsFeed - 12 Oct 2018
FDA Approves Grifols ID CORE XT Test For Molecular Red Blood Cell Typing
Diagnostics FDA

HSMN NewsFeed - 23 Aug 2018
Roche receives FDA approval for cobas EGFR Mutation Test v2 as companion diagnostic with IRESSA (gefitinib) in first-line treatment of patients with non-small cell lung cancer (NSCLC)
Diagnostics Oncology FDA

HSMN NewsFeed - 26 Jul 2018
Cepheid Receives FDA Clearance and CLIA Waiver for Xpert(R) Xpress Flu/RSV Test
Diagnostics FDA Product Launch

HSMN NewsFeed - 19 Jun 2018
GenomeDx Biosciences and Pathnostics Launch Enhanced Version of Guidance Tests
Diagnostics Oncology Product Launch

HSMN NewsFeed - 19 Feb 2018
GenePOC Launches Its revogene(TM) Instrument and GBS LB Test in Canada
Diagnostics Product Launch

HSMN NewsFeed - 6 Dec 2017
Third Respiratory Assay Now FDA Cleared on Hologic's New Panther Fusion(R) System
Diagnostics FDA Product Launch

HSMN NewsFeed - 28 Nov 2017
GenePOC Launches its GenePOC(TM) CDiff Test in the United States
Diagnostics FDA Product Launch

HSMN NewsFeed - 5 Oct 2017
Cepheid Expands Respiratory Disease Portfolio with Xpert Xpress Strep A
Diagnostics FDA

HSMN NewsFeed - 2 Oct 2017
Alere Receives FDA Clearance for Alere(TM) i Influenza A & B 2 Rapid Molecular Test
Diagnostics FDA

HSMN NewsFeed - 24 Jul 2017
Luminex Corporation Receives FDA Clearance for ARIES C. difficile Assay
Diagnostics FDA

HSMN NewsFeed - 29 Jun 2017
Hologic's New Panther Fusion(R) System, Flu and Respiratory Assays Now CE Marked in Europe
Diagnostics Regulatory

HSMN NewsFeed - 28 Jun 2017
Luminex Corporation Receives CE-IVD Mark for ARIES(R) Norovirus Assay
Diagnostics Regulatory

HSMN NewsFeed - 1 Jun 2017
GenePOC Announces FDA Clearance for Revogene(TM) Instrument and its GBS LB Test
Diagnostics FDA

HSMN NewsFeed - 24 May 2017
PositiveID Forms ExcitePCR Subsidiary to Better Position its Firefly Dx System for $19 Billion Global Point-of-Care Diagnostics Market
Diagnostics

HSMN NewsFeed - 3 May 2017
Luminex Corporation Receives FDA Clearance for ARIES Bordetella Assay
Diagnostics FDA

HSMN NewsFeed - 31 Oct 2016
BD MAX(TM) Vaginal Panel Receives FDA Market Authorization to Detect Most Common Causes of Vaginal Infections
Diagnostics FDA

HSMN NewsFeed - 6 Sep 2016
BD Submits Pre-Market Approval Application to FDA for BD Onclarity(TM) HPV Test
Diagnostics FDA

HSMN NewsFeed - 31 Aug 2016
XALKORI(R) (Crizotinib) Receives Approval In European Union For The Treatment Of Patients With ROS1-Positive Advanced Non-Small Cell Lung Cancer
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 19 Aug 2016
Alere Receives FDA Clearance for Alere(TM) i RSV Rapid Molecular Test
Diagnostics FDA

HSMN NewsFeed - 1 Aug 2016
Roche receives CLIA waiver for cobas(R) Influenza A/B & RSV test for the cobas(R) Liat(R)
Diagnostics FDA

HSMN NewsFeed - 20 Jul 2016
Viracor-IBT Laboratories, Inc.'s Zika Virus RT-PCR Test Receives Emergency Use Authorization From the FDA
Diagnostics FDA

HSMN NewsFeed - 25 May 2016
Roche announces the first FDA-approved CMV test for use in hematopoietic stem cell transplant recipients
Diagnostics FDA

HSMN NewsFeed - 16 May 2016
Luminex Corporation Signs Definitive Agreement to Acquire Nanosphere, Inc.
Diagnostics Mergers & Acquisitions

HSMN NewsFeed - 5 May 2016
Applied DNA Sciences Appoints Bob Miglani as Chief of Business Development
Biopharmaceuticals Personnel

HSMN NewsFeed - 21 Mar 2016
FDA approves expanded use of Roche hepatitis C virus RNA test as aid in diagnosis
Diagnostics FDA

HSMN NewsFeed - 7 Oct 2015
Luminex Corporation Receives FDA Clearance for ARIES(R) System and ARIES(R) HSV 1&2 Assay
Diagnostics FDA

HSMN NewsFeed - 16 Jul 2015
Alere Receives FDA CLIA Waiver for Alere(TM) i Strep A Rapid Molecular Test
Diagnostics FDA

HSMN NewsFeed - 11 May 2015
Roche Receives FDA Approval for cobas(R) KRAS Mutation Test
Diagnostics Oncology FDA

HSMN NewsFeed - 26 Jan 2015
Roche receives FDA clearance for next generation cobas MRSA/SA Test
Diagnostics FDA

HSMN NewsFeed - 24 Apr 2014
FDA Approves Roche's HPV Test for First-Line Primary Screening for Cervical Cancer
Diagnostics Oncology FDA

HSMN NewsFeed - 20 Aug 2013
DermTech Raises $5.6 Million in Series B Financing
Diagnostics Oncology Venture Capital

HSMN NewsFeed - 27 Jun 2013
Cepheid Receives FDA Clearance For Updated Xpert MRSA/SA Blood Culture (BC) Test
Diagnostics FDA

HSMN NewsFeed - 25 Jun 2013
BioFire Receives FDA Clearance for the FilmArray(R) Blood Culture Identification Panel
Diagnostics FDA

HSMN NewsFeed - 19 Nov 2012
Abacus Diagnostica Receives CE Mark for its Rapid Direct PCR Test for Toxigenic Clostridium Difficile
Diagnostics Regulatory

HSMN NewsFeed - 16 Oct 2012
Clinical Study Validates Sequenta’s LymphoSIGHT(TM) Platform as More Sensitive Alternative to Flow Cytometry for Cancer Detection
Diagnostics Oncology

HSMN NewsFeed - 25 Sep 2012
Life Technologies Launches Pervenio(TM) Lung RS, a Risk Stratification Test for Early Stage Lung Cancer
Diagnostics Oncology

HSMN NewsFeed - 18 Jul 2012
NeoGenomics Significantly Expands Molecular Testing Menu and Launches NeoTYPE(TM) Cancer Profile Panels
Diagnostics Personalized Medicine Oncology

HSMN NewsFeed - 26 Jun 2012
Caris Life Sciences Launches Caris Target Now(TM) Select for NSCLC, Melanoma, and Cancers of the Breast, Colon, and Ovary
Diagnostics Oncology

HSMN NewsFeed - 17 Apr 2012
QIAGEN Receives FDA Clearances for Rotor-Gene Q MDx Instrument and Compatible Influenza A/B Assay
Diagnostics FDA

HSMN NewsFeed - 22 Mar 2012
OrbusNeich's Genous(TM) Technology Effectively Promotes Endothelialization and Reduces Thrombogenicity
Devices Interventional Cardiology

HSMN NewsFeed - 31 Aug 2011
NexBio's DAS181 (Fludase(R)*) Improves Symptoms in Four Severely Immunocompromised Patients With Life-Threatening Parainfluenza Pneumonitis
Biopharmaceuticals

HSMN NewsFeed - 17 Aug 2011
FDA Approves Zelboraf (Vemurafenib) and Companion Diagnostic for BRAF Mutation-Positive Metastatic Melanoma, a Deadly Form of Skin Cancer
Biopharmaceuticals Oncology Personalized Medicine FDA

HSMN NewsFeed - 18 May 2011
Abbott Receives FDA Approval for Molecular Test for Hepatitis C
Diagnostics FDA

HSMN NewsFeed - 19 Jan 2011
Genentech Personalized Investigational Medicine Shows Survival Benefit in Advanced Skin Cancer
Biopharmaceuticals Diagnostics Personalized Medicine

HSMN NewsFeed - 8 Dec 2010
Prodesse ProAdeno+ Assay Cleared for US Marketing by FDA
Diagnostics FDA

HSMN NewsFeed - 6 Dec 2010
Pfizer Announces Phase 3 Results of Investigational Compound Bosutinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia
Biopharmaceuticals Oncology

HSMN NewsFeed - 20 Sep 2010
Celera Signs Agreement with Abbott for Distribution of CE-marked KIF6 Test to Identify Patients at Risk of Coronary Heart Disease
Diagnostics Cardiology Distribution

HSMN NewsFeed - 28 Jun 2010
Abbott Receives FDA Clearance for Molecular Diagnostic Test for Detection of Chlamydia and Gonorrhea Infections
Diagnostics FDA

HSMN NewsFeed - 8 Jun 2010
Cepheid Receives FDA Clearance for Xpert SA Nasal Complete, the First Molecular Test for Simultaneous Detection and Differentiation of S. aureus & MRSA Colonization
Diagnostics FDA

HSMN NewsFeed - 3 Mar 2010
Abbott to Collaborate With GSK on Molecular Diagnostic Test to Select Candidate Patients for Future Skin Cancer Immunotherapy
Diagnostics Biopharmaceuticals Oncology

HSMN NewsFeed - 17 Feb 2010
Roche Collaborates with Merck on Developmental Test for Cancer-Related Gene Mutation
Diagnostics Oncology

HSMN NewsFeed - 6 Jan 2010
Cepheid Receives FDA Clearance for First Rapid and Accurate Surveillance Test for vanA the Resistance Gene Most Associated with Hospital-Acquired VRE Infections
Diagnostics FDA

HSMN NewsFeed - 4 Jan 2010
Cepheid Receives FDA Emergency Use Authorization (EUA) for First 2009 H1N1 Influenza Assay for CLIA 'Moderate Complexity' Laboratories
Diagnostics FDA

HSMN NewsFeed - 8 Dec 2009
Novartis Tasigna(R) Trial Shows Superior Results to Gleevec(R) in Patients With Early-Stage Chronic Myeloid Leukemia
Biopharmaceuticals Oncology

HSMN NewsFeed - 29 Oct 2009
FDA Grants Emergency Use Authorization of the Prodesse ProFlu-ST(TM)
Diagnostics FDA

HSMN NewsFeed - 6 Oct 2009
Gen-Probe to Acquire Prodesse, Leader in Molecular Testing for Respiratory Infectious Diseases, for $60 Million in Cash Plus Potential Milestone Payments
Diagnostics Acquisitions

HSMN NewsFeed - 13 Jul 2009
Cepheid Receives FDA Clearance for First On-Demand Molecular Diagnostic Test for Clostridium difficile Infection
Diagnostics FDA

HSMN NewsFeed - 5 May 2009
Aethlon Medical Discloses New HIV/AIDS Treatment Data
Devices HIV/AIDS

HSMN NewsFeed - 2 Apr 2009
Roche to Introduce New LightCycler(R) MRSA Advanced Test in the EU
Diagnostics Regulatory

HSMN NewsFeed - 11 Mar 2009
Aethlon Medical Announces Significant Viral Load Reduction in Landmark Medical Device Study to Treat HIV/AIDS
Devices HIV/AIDS

HSMN NewsFeed - 9 Feb 2009
ViroPharma Reports Results of Phase 3 Clinical Trial for Maribavir in Bone Marrow Transplant Patients
Biopharmaceuticals

HSMN NewsFeed - 26 Jan 2009
Sequenom Expands Molecular Diagnostics Portfolio with Acquisition of SensiGen
Diagnostics Acquisitions

HSMN NewsFeed - 13 Jan 2009
Abbott Introduces RealTime Molecular Assay in Europe for Detection of HPV Infection
Diagnostics

HSMN NewsFeed - 10 Dec 2008
Diagnoplex Closes CHF10 Million ($8.3 Million) Series A Financing
Diagnostics Oncology Venture Capital

HSMN NewsFeed - 10 Nov 2008
Cepheid Launches First On-Demand Molecular Diagnostic Test for Clostridium Difficile Into European Market
Diagnostics

HSMN NewsFeed - 1 Oct 2008
Cepheid Receives FDA Clearance for First On-Demand Diagnostic Test for Life-Threatening MRSA and Staphylococcus aureus From Patient Positive Blood Cultures
Diagnostics FDA

HSMN NewsFeed - 29 Sep 2008
Cepheid Receives FDA Clearance for First Rapid On-Demand Molecular Diagnostic Test for MRSA and S. aureus
Diagnostics FDA

HSMN NewsFeed - 12 May 2008
Cepheid Signs Group Purchasing Contract With Premier Healthcare Alliance, One of the Largest U.S. Group Purchasing Organizations
Diagnostics Group Purchasing

HSMN NewsFeed - 1 May 2008
BD Announces CE Marking of the BD GeneOhm(TM) VanR Molecular Test for the Rapid Detection of Vancomycin Resistance
Diagnostics Regulatory

HSMN NewsFeed - 25 Feb 2008
Cepheid and Instrumentation Laboratory Introduce Xpert(TM) HemosIL(R) FII & FV Assay to European Clinical Testing Market
Diagnostics

HSMN NewsFeed - 29 Jan 2008
Cepheid Receives Health Canada Medical Device License for Xpert MRSA(TM) Test and GeneXpert(R) System
Diagnostics Regulatory

HSMN NewsFeed - 4 Dec 2007
Cepheid Launches New GeneXpert(R) Tests in Europe for Simultaneous, Rapid Detection of Staphylococcus Aureus and Methicillin Resistant Staphylococcus Aureus
Diagnostics

HSMN NewsFeed - 29 Nov 2007
Cepheid and Broadlane Sign Group Purchasing Contract for GeneXpert(R) Systems and Xpert(TM) Molecular Diagnostic Tests, Including Xpert MRSA
Diagnostics Group Purchasing

HSMN NewsFeed - 20 Nov 2007
Health Canada Licenses QIAGEN's New Molecular Test for Hepatitis B
Diagnostics Regulatory

HSMN NewsFeed - 2 Nov 2007
Ninety-one Percent of BARACLUDE(R) (entecavir) Treated Patients in a Four-Year Cohort Demonstrated Virologic Suppression to Undetectable Levels
Biopharmaceuticals

HSMN NewsFeed - 5 Sep 2007
Bar Harbor BioTechnology Inc. Completes Series A Financing for Product Launch
Biopharmaceuticals Venture Capital

HSMN NewsFeed - 28 Aug 2007
FDA Approves New Roche West Nile Virus Blood Screening Test
Diagnostics FDA

HSMN NewsFeed - 9 Aug 2007
Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
Diagnostics HIV/AIDS FDA

HSMN NewsFeed - 21 Jun 2007
Abbott's RealTime Hepatitis B Viral Load Test Receives CE Marking in Europe
Diagnostics Regulatory

HSMN NewsFeed - 21 May 2007
BARACLUDE(R) (Entecavir) Treatment Demonstrated Greater Viral Load Reduction Compared to Adefovir at 48 Weeks in Study of Antiviral-Naive Chronic Hepatitis B E-Antigen Positive Patients
Biopharmaceuticals

HSMN NewsFeed - 18 Apr 2007
Cepheid's Xpert(TM) MRSA Test for Methicillin-Resistant Staphylococcus Aureus Receives FDA Clearance
Diagnostics FDA

HSMN NewsFeed - 14 Apr 2007
Four-Year Data Demonstrate Continued Low Incidence of BARACLUDE(R) (entecavir) Resistance in Nucleoside-naive Chronic Hepatitis B Patients
Biopharmaceuticals

HSMN NewsFeed - 13 Apr 2007
BARACLUDE(R) (entecavir) Therapy Resulted in Undetectable Levels of Hepatitis B Virus in Cohort of Patients Who Re-Started Treatment
Biopharmaceuticals

HSMN NewsFeed - 11 Apr 2007
Cepheid's Xpert(TM) EV Test for Enteroviral Meningitis Gains Adoption at Approximately 20 Leading U.S. Medical Centers
Diagnostics

HSMN NewsFeed - 19 Mar 2007
Cepheid's Xpert(TM) EV Test for Enteroviral Meningitis, Run on the GeneXpert Platform, Receives FDA Clearance
Diagnostics FDA

HSMN NewsFeed - 20 Feb 2007
Althea Technologies Announces the Development of a Diagnostic Capable of Differentiating Multiple Forms of Childhood Cancer
Diagnostics Oncology

HSMN NewsFeed - 7 Feb 2007
IRIS Submits 510(k) Application To FDA For Its N.A.D.I.A. Prostate Cancer Test
Diagnostics Oncology FDA

HSMN NewsFeed - 17 Jan 2007
Roche Diagnostics Submits West Nile Virus Blood Screening Test to FDA
Diagnostics

HSMN NewsFeed - 8 Jan 2007
Abbott m2000(TM) Molecular Diagnostic Instrument and Viral Load Tests for HIV-1 and HCV Approved in Canada
Diagnostics Regulatory

HSMN NewsFeed - 4 Dec 2006
Janus Pharmaceuticals Inc. Announces Successful Phase II Study in Shingles
Biopharmaceuticals

HSMN NewsFeed - 30 Oct 2006
Three-Year Data Showed Low Incidence of BARACLUDE(R) (Entecavir) Resistance in Nucleoside-Naive Chronic Hepatitis B Patients
Biopharmaceuticals

HSMN NewsFeed - 30 Oct 2006
BARACLUDE(R) (Entecavir) Demonstrated Viral Suppression to Undetectable Levels in Most Patients in a Three-Year Cohort
Biopharmaceuticals

HSMN NewsFeed - 30 Oct 2006
Study Shows Treatment with BARACLUDE(R) (Entecavir) Resulted in Greater Viral Load Reductions Compared to Adefovir in Antiviral Naive Chronic Hepatitis B E-Antigen Positive Patients
Biopharmaceuticals

HSMN NewsFeed - 26 Oct 2006
Cepheid Extends European Product Line With Launch of Xpert(TM) MRSA Test for GeneXpert(R) System
Diagnostics

HSMN NewsFeed - 5 Oct 2006
Gen-Probe Receives FDA Approval for APTIMA(R) HIV-1 RNA Qualitative Assay for Clinical Diagnostic Use
Diagnostics FDA

HSMN NewsFeed - 28 Sep 2006
ViroPharma Initiates First of Two Phase 3 Studies of Maribavir in Transplant Patients
Biopharmaceuticals

HSMN NewsFeed - 21 Jul 2006
Abbott to Preview m2000(TM) Real-Time PCR Diagnostics System Designed to Provide Fast, Efficient Testing in the Molecular Lab
Diagnostics

HSMN NewsFeed - 16 May 2006
FDA Gives Permission to Use Very Sensitive Molecular Evidence of Cancer in BiovaxID Pivotal Phase 3 Clinical Trial
Biopharmaceuticals Oncology FDA

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