Roche receives FDA clearance for COVID-19 PCR test to be used

Roche receives FDA clearance for COVID-19 PCR test to be used

  • The cobas Qualitative SARS-CoV-2 check is without doubt one of the first COVID-19s PCR assessments carried out on a high-throughput automated platform to obtain FDA 510(ok) clearance.
  • This FDA clearance will make sure that the healthcare group has entry to quick, dependable, and correct COVID-19 PCR testing past the EUA interval.
  • Based mostly on ongoing testing for the reason that begin of the pandemic, all of Roche’s molecular assessments, together with the cobas SARS-CoV-2 Qualitative check, detects all variants of SARS-CoV-2.

Basel, October 24, 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) in the present day introduced that the U.S. Meals and Drug Administration (FDA) has granted 510(ok) clearance for the cobas® check SARS-CoV-2 Qualitative PCR to be used on absolutely automated cobas® 6800 and cobas® 8800 techniques. This stand-alone check is meant for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 illness, in nasal and nasopharyngeal specimens from symptomatic sufferers suspected of getting COVID-19, as decided by their healthcare supplier.

The qualitative cobas SARS-CoV-2 check has been out there in the US underneath emergency use authorization (EUA) since March 2020 and was the primary business molecular check to obtain this standing. FDA clearance is predicated on a whole file submitted to the company, together with analytical and medical research.

“We’re delighted to have handed this regulatory milestone. Roche is absolutely dedicated to continued help and innovation for COVID-19 diagnostics to satisfy evolving healthcare wants and assist maintain communities secure,” stated Thomas Schinecker, CEO of Roche Diagnostics. “We’re actively working with well being authorities to acquire FDA clearance standing for the assessments in our COVID-19 portfolio. This may guarantee clinicians and sufferers have continued entry to correct, dependable and environment friendly testing choices. »

With the continued evolution of coronavirus variants and frequent energy surges occurring all over the world, Roche will proceed so as to add diagnostic options to the worldwide portfolio to assist fight COVID-19. For extra info on how Roche is responding to the worldwide public well being disaster associated to COVID-19, please see our COVID-19 Response Page.

About cobas SARS-CoV-2 qualitative check
The cobas SARS-CoV-2 Qualitative Check is a single-well, dual-target check, which incorporates each particular detection of SARS-CoV-2 and pan-sarbecovirus detection for the sarbecovirus subgenus which incorporates SARS- CoV-2. The check is a real-time RT-PCR check supposed for the qualitative detection of SARS-CoV-2 nucleic acids in nasal and nasopharyngeal swab specimens collected from symptomatic people with suspected COVID-19 by their well being care supplier. well being. The check runs on the cobas 6800/8800 techniques and features a full damaging management, a constructive management and an inner management.

Damaging outcomes don’t rule out SARS-CoV-2 an infection and shouldn’t be used as the only foundation for affected person administration choices. The outcomes are supposed for use at the side of medical observations, affected person historical past, current exposures, and epidemiological info and laboratory information, in accordance with tips supplied by related public well being authorities.

The cobas® SARS-CoV-2 Qualitative Check is meant to be used by certified medical laboratory personnel particularly instructed and educated in real-time PCR methods and the usage of the cobas® 6800/8800 Techniques.

About cobas 6800/8800 techniques
The Roche cobas 6800/8800 techniques, that are used to carry out the cobas SARS-CoV-2 check, present ends in three and a half hours and supply working effectivity, flexibility and sooner outcomes with the best throughput offering as much as 96 ends in roughly three hours and a complete of 1440 outcomes for the cobas 6800 System and 4128 outcomes for the cobas 8800 System in 24 hours. The check might be run concurrently with different assessments provided by Roche to be used on the cobas 6800/8800 techniques.

For extra info on the assessments and the system, please go to www.diagnostics.roche.com.

About Roche
Based in 1896 in Basel, Switzerland, as one of many first industrial producers of branded medication, Roche has change into the world’s largest biotechnology firm and the world chief in in vitro diagnostics. The corporate pursues scientific excellence to find and develop medicines and diagnostics to enhance and save the lives of individuals all over the world. We’re a pioneer in customized healthcare and need to additional rework the way in which healthcare is delivered to have a good higher impression. To supply the most effective take care of every particular person, we accomplice with many stakeholders and mix our strengths in diagnostics and pharmacy with insights from medical observe.

In recognition of our efforts to pursue a long-term perspective in every little thing we do, Roche has been named one of the sustainable firms within the pharmaceutical trade by the Dow Jones Sustainability Indexes for the thirteenth consecutive 12 months. This distinction additionally displays our efforts to enhance entry to healthcare with native companions in all of the international locations the place we work.

Genentech, in the US, is a full member of the Roche group. Roche is almost all shareholder of Chugai Pharmaceutical, Japan.

For extra info, please go to www.roche.com.

All emblems used or talked about on this press launch are protected by regulation.

References
[1] World Well being Group [Internet; cited 2020 Jan]. Out there from https://www.who.int/health-topics/coronavirus.

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