register

News & Trends - MedTech & Diagnostics

First bedside point-of-care test approved for COVID-19 virus

Health Industry Hub | March 23, 2020 |

MedTech News: Cepheid point-of-care diagnostic test is the first to receive Emergency Use Authorisation from the U.S. Food & Drug Administration (FDA) for qualitative detection of SARS-CoV.

The test is designed to operate on any of Cepheid’s more than 23,000 automated GeneXpert Systems worldwide, with a detection time of approximately 45 minutes.

Although the TGA is providing exemptions for the immediate supply of COVID-19 tests, the prospect of introducing this approach of identifying asymptomatic people and isolating them is not currently practical on a large scale. There are not enough tests to go around. COVID-19 testing is really targeted for high-risk patients and patients who show signs and symptoms of the disease. Broad based testing at this stage is simply not feasible.

Register FREE and join 20,000+ industry professionals who receive the latest industry news, innovations and insights from Health Industry Hub; the ONLY one-stop-hub connecting Australia’s Pharma, MedTech and Biotech industry professionals.

“During this time of increased demand for hospital services, clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities. An accurate test delivered close to the patient can be transformative and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources,” said Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid.

“By leveraging the design principles of our current Xpert Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted to provide rapid detection of current and potential future variants of SARS-CoV-2, we have developed a test that provides reference lab-quality results in multiple settings where actionable treatment information is needed quickly.”

“Our automated systems do not require users to have specialty training to perform testing — they are capable of running 24/7, with many systems already doing so today.” said Cepheid President Warren Kocmond.

The test will begin shipping next week in the U.S. and is pending review by international regulatory agencies, including Australia’s TGA.

Customer engagement during COVID-19 – solutions developed by industry for industry. Learn more about how we can help your team. We combine our expertise in delivering and measuring the engagement from digital health content, with 20+ years industry experience.


News & Trends - Pharmaceuticals

Clinicians unveil Novartis and BMS practice-changing trial results

Clinicians unveil Novartis and BMS practice-changing trial results

Health Industry Hub | June 24, 2024 |

Pharma News: Australia, known for its alarming melanoma rates, witnesses one person diagnosed with the disease every 30 minutes, and […]

More


News & Trends - Pharmaceuticals

Hearts4heart leads awareness week, amid progress in Boehringer Ingelheim and AstraZeneca therapies

Hearts4heart leads awareness week, amid progress in Boehringer Ingelheim and AstraZeneca therapies

Health Industry Hub | June 24, 2024 |

Pharma News: Heart failure is a significant health concern in Australia, affecting approximately half a million people, with over 67,000 […]

More


News & Trends - MedTech & Diagnostics

Cardiologists mark Australian first with Boston Scientific's intracoronary imaging system

Cardiologists mark Australian first with Boston Scientific’s intracoronary imaging system

Health Industry Hub | June 24, 2024 |

MedTech & Diagnostics News: Percutaneous coronary intervention (PCI) has faced substantial complications and failure rates, despite advances in medical devices […]

More


Leadership & Management

AbbVie New Zealand welcomes new leadership amid global moves

AbbVie New Zealand welcomes new leadership amid global moves

Health Industry Hub | June 24, 2024 |

Leadership & Management: In line with its global talent development plan, AbbVie has announced a significant change in leadership for […]

More


This content is copyright protected. Please subscribe to gain access.