November 17, 2021 Clinical Research/Diagn.

Karolinska Institutet & MedTechLabs Kickoff The World’s First Clinical Evaluation of GE Healthcare’s Photon Counting CT Technology with Deep Silicon Detectors

Photon counting CT has the promise to further expand the capabilities of traditional CT Karolinska Institutet and MedTechLabs’ pilot study represents the first of its kind to test pure silicon CT detector technology for photon counting CT in a clinical setting The project is the result of close collaborations between healthcare, academia and business Chicago,... Read more

November 17, 2021 Clinical Research/Diagn.

Karolinska Institutet & MedTechLabs Kickoff The World’s First Clinical Evaluation of GE Healthcare’s Photon Counting CT Technology with Deep Silicon Detectors

Photon counting CT has the promise to further expand the capabilities of traditional CT Karolinska Institutet and MedTechLabs’ pilot study represents the first of its kind to test pure silicon CT detector technology for photon counting CT in a clinical setting The project is the result of close collaborations between healthcare, academia and business Chicago,... Read more

November 12, 2021 Clinical Research/Diagn.

Ronapreve approved by European Commission to treat non-hospitalised COVID-19 patients and for prophylaxis of the disease

EU marketing authorisation follows approvals in Japan, the United Kingdom and Australia Approval based on data demonstrating Ronapreve reduced risk of hospitalisation in certain patients with mild to moderate disease and reduced risk of symptomatic COVID-19 infections in people exposed to the virus Basel, 12 November 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today... Read more

November 11, 2021 Clinical Research/Diagn.

CHMP recommends EU approval of Ronapreve to treat non-hospitalised COVID-19 patients and for prophylaxis of the disease

Recommendation based on data demonstrating Ronapreve reduced risk of hospitalisation in certain patients with mild to moderate disease and reduced risk of symptomatic COVID-19 infections in people exposed to the virus Ronapreve’s combination approach continues to retain neutralisation activity against variants of concern Basel, 11 November 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today... Read more

November 9, 2021 Clinical Research/Diagn. Lab Top-10 Microscopy Product Launch

New IVD System Enables Assay Developers and Clinical Laboratories to Accelerate Molecular Diagnostics Growth

New IVD System Enables Assay Developers and Clinical Laboratories to Accelerate Molecular Diagnostics Growth Thermo Fisher Scientific expands diagnostics portfolio to support full qPCR assay development and testing workflow CARLSBAD, Calif., Nov. 9, 2021 /PRNewswire/ — As assay developers and clinical testing laboratories consider next steps for molecular diagnostics post-pandemic, a new in vitro diagnostic (IVD)... Read more

October 22, 2021 Clinical Research/Diagn. PR/Corporate

BD Names Dr. Carrie Byington To Board Of Directors

FRANKLIN LAKES, N.J., Oct. 22, 2021 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that Dr. Carrie L. Byington has been appointed to the company’s board of directors, bringing the total number of directors to 13. Byington, 58, is executive vice president and head of University of California Health (UCH), where she... Read more

October 22, 2021 Acad, Gov/Utilities Bio/Pharma/CRO Clinical Research/Diagn. PR/Corporate

Roche’s VENTANA PD-L1 (SP263) Assay receives FDA approval as a companion diagnostic to identify certain non-small cell lung cancer patients eligible for Tecentriq® (atezolizumab)

Lung cancer remains the leading cause of cancer-related deaths worldwide, with more than 2.2 million people diagnosed globally last year.1 The VENTANA PD-L1 (SP263) Assay helps determine which non-small cell lung cancer patients may benefit from treatment with Tecentriq immunotherapy based on the results of the Phase III IMpower010 study. This new test expands Roche’s... Read more

October 21, 2021 Clinical Research/Diagn. Licensing, IP, and Legal

Agilent PD-L1 IHC 28-8 pharmDx Receives CE-IVD Mark as a Companion Diagnostic Test in Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

SANTA CLARA, Calif., October 21, 2021  Agilent Technologies Inc. (NYSE: A) today announced it has received CE-IVD mark approval for the PD-L1 IHC 28-8 pharmDx to guide options for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal cancers. Gastric (stomach) cancer is the fifth most common cancer and... Read more

October 13, 2021 Clinical Research/Diagn. Licensing, IP, and Legal

Agilent Receives FDA Companion Diagnostic Approval for Ki-67 IHC MIB-1 pharmDx in High-Risk Early Breast Cancer

SANTA CLARA, Calif., October 13, 2021  Agilent Technologies Inc. (NYSE: A) today announced its Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is now FDA approved as an aid in identifying patients with early breast cancer (EBC) at high risk of disease recurrence, for whom adjuvant treatment with Verzenio® (abemaciclib) in combination with endocrine therapy is being considered.... Read more