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Antigen Level Articles & Analysis

13 news found

Tempus Announces the Clinical Launch of its MRD Testing Portfolio

Tempus Announces the Clinical Launch of its MRD Testing Portfolio

The research demonstrates a clinical sensitivity at a landmark of 61.1% and a robust surveillance performance with longitudinal sensitivity of 83.3% and specificity of 89.5% across stage II/III CRC patients. xM MRD results predict disease-free survival (DFS) nearly 5 times stronger compared to standard of care carcinoembryonic antigen (CEA) level (Adj. Hazard ...

ByTempus


Bayer expands global clinical program for darolutamide in prostate cancer

Bayer expands global clinical program for darolutamide in prostate cancer

BCR is defined as rising prostate-specific antigen (PSA) levels with a doubling time of after primary treatment (surgery or radiotherapy).1,2 Darolutamide is already approved under the brand name NubeqaTM for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease as well ...

ByBayer AG


Nubeqa (darolutamide) approved for additional prostate cancer indication in China

Nubeqa (darolutamide) approved for additional prostate cancer indication in China

In addition, a study to explore the potential of darolutamide in the early setting for patients who have experienced a rise in their prostate specific antigen (PSA) levels following surgery or radiation, is also planned. ...

ByBayer AG


Nubeqa (darolutamide) receives EU approval for additional indication in prostate cancer

Nubeqa (darolutamide) receives EU approval for additional indication in prostate cancer

In addition, a study to explore the potential of darolutamide in the early setting for patients who have experienced a rise in their prostate specific antigen (PSA) levels following surgery or radiation, is also planned. ...

ByBayer AG


Nubeqa approved for additional indication in Japan

Nubeqa approved for additional indication in Japan

In addition, a study to explore the potential of darolutamide in the early setting for patients who have experienced a rise in their prostate specific antigen (PSA) levels following surgery or radiation, is also planned. ...

ByBayer AG


New data presented at ASCO GU confirm survival benefits and favorable safety profile of darolutamide across different subgroups of patients with metastatic hormone-sensitive prostate cancer

New data presented at ASCO GU confirm survival benefits and favorable safety profile of darolutamide across different subgroups of patients with metastatic hormone-sensitive prostate cancer

In addition, a study to explore the potential of darolutamide in the early setting for patients who have experienced a rise in their prostate specific antigen (PSA) levels following surgery or radiation, is also planned. ...

ByBayer AG


CHMP recommends Bayer’s darolutamide for the treatment of metastatic hormone-sensitive prostate cancer

CHMP recommends Bayer’s darolutamide for the treatment of metastatic hormone-sensitive prostate cancer

In addition, a study to explore the potential of darolutamide in the early setting for patients who have experienced a rise in their prostate specific antigen (PSA) levels following surgery or radiation, is also planned. ...

ByBayer AG


Blue Earth Diagnostics Highlights Axumin (Fluciclovine F 18) Presentation at Upcoming 22nd Annual Scientific Meeting in Urologic Oncology (SUO)

Blue Earth Diagnostics Highlights Axumin (Fluciclovine F 18) Presentation at Upcoming 22nd Annual Scientific Meeting in Urologic Oncology (SUO)

NOTE: Axumin® (fluciclovine F 18) injection is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. HIGHLIGHTED SCIENTIFIC PRESENTATION Friday, December 3, 2021 SUO presentations are available at designated times for the meeting in Orlando and ...

ByBlue Earth Diagnostics


Blue Earth Diagnostics Highlights Presentations on Axumin® (Fluciclovine F 18) and 18F-Fluciclovine at Upcoming ASTRO Annual Meeting

Blue Earth Diagnostics Highlights Presentations on Axumin® (Fluciclovine F 18) and 18F-Fluciclovine at Upcoming ASTRO Annual Meeting

NOTE: Axumin® (fluciclovine F 18) injection is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. Presentations noted by "*" discuss results of investigational studies of an approved product that is not approved by the FDA for the specific use ...

ByBlue Earth Diagnostics


Bayer raises peak sales for Nubeqa to exceed three billion euro amid positive Phase III ARASENS trial data

Bayer raises peak sales for Nubeqa to exceed three billion euro amid positive Phase III ARASENS trial data

In addition, a study to explore the potential of darolutamide in the early setting for patients who have been treated with surgery or radiation and now see a rise in their prostate specific antigen (PSA) levels is also planned. About Nubeqa (darolutamide) Darolutamide is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to ...

ByBayer AG


Vaccitech reports promising interim efficacy analysis in Phase 1b/2a clinical study in chronic HBV

Vaccitech reports promising interim efficacy analysis in Phase 1b/2a clinical study in chronic HBV

Interim data from 27 patients, who had completed 3 months in the HBV002 study in chronic Hepatitis B (CHB) patients, demonstrated noted changes in surface antigen (HBsAg) levels, especially in the group receiving low-dose nivolumab with the heterologous boost (VTP-300). ...

ByVaccitech plc


Blue Earth Diagnostics Announces Results of an Analysis of the Impact of Axumin® (Fluciclovine F 18) PET/CT Imaging on Androgen Deprivation Therapy (ADT) Planning in Recurrent Prostate Cancer

Blue Earth Diagnostics Announces Results of an Analysis of the Impact of Axumin® (Fluciclovine F 18) PET/CT Imaging on Androgen Deprivation Therapy (ADT) Planning in Recurrent Prostate Cancer

Axumin, a novel amino acid-based radiopharmaceutical, is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. The secondary analysis is based on the Axumin LOCATE and FALCON trials, which have safety profiles consistent with that described in the ...

ByBlue Earth Diagnostics


NanoPin Technologies Announces a Research Collaboration Agreement to Advance a Rapid Blood-based Test for Tuberculosis and Infectious Diseases

NanoPin Technologies Announces a Research Collaboration Agreement to Advance a Rapid Blood-based Test for Tuberculosis and Infectious Diseases

NanoPin is bringing to market a diagnostic platform that sensitively detects TB antigen levels present in patient blood samples in a matter of hours. ...

ByNanoPin Technologies Inc.

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