BD, CerTest win FDA EUA for monkeypox diagnostic

The BD Max system. [Image from BD]BD (NYSE:BDX) and CerTest Biotec announced today that their monkeypox diagnostic received FDA emergency use authorization (EUA).

Franklin Lakes, New Jersey-based BD and Zaragoza, Spain-based CerTest announced a partnership to develop the test in June. The Viasure monkeypox (Mpox) virus real-time PCR assay works with the BD Max system.

The automated platform, performs nucleic acid extraction and real-time PCR testing. It provides results for up to 24 samples across multiple syndromes in less than three hours, the company said.

The companies made the diagnostic available outside of the U.S. for use in research applications by laboratories in July. They went on to launch it for lab research in the U.S. in September.

“The Mpox outbreak continues to be designated as a global health emergency — the World Health Organization’s highest level of alert,” said Nikos Pavlidis, VP of molecular diagnostics at BD.…

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BD, CerTest launch monkeypox diagnostic for lab research in U.S.

The BD Max system. [Image from BD]BD (NYSE:BDX) and CerTest Biotec announced today that they made their monkeypox virus assay commercially available for global research.

The companies made the diagnostic available outside of the U.S. for use in research applications by laboratories in July. The molecular polymerase chain reaction (PCR) assay is now available globally for research applications only.

Franklin Lakes, New Jersey-based BD and Zaragoza, Spain-based CerTest announced a partnership to develop the test in June.

The CDC began tracking a monkeypox outbreak in the United States and other countries that don’t normally report cases of the infectious virus earlier this year. Monkeypox is said to cause a rash and lesions and is mainly shared through direct physical contact. The CDC warns it can also be transmitted via respiratory secretions during prolonged, face-to-face contact.

To date, the CDC reports 24,846 U.S. monkeypox cases and one related d…

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BD, CerTest launch monkeypox diagnostic for lab research outside the U.S.

The BD Max system. [Image from BD]BD (NYSE:BDX) and CerTest Biotec announced today that they made their monkeypox virus diagnostic commercially available.

The newly developed molecular polymerase chain reaction (PCR) test for monkeypox has been made available outside of the U.S. of use in research applications by laboratories.

Franklin Lakes, New Jersey-based BD and Zaragoza, Spain-based CerTest announced a partnership to develop the test last month after the CDC said it was tracking a monkeypox outbreak in the United States and other countries that don’t normally report cases of the infectious virus. Monkeypox is said to cause a rash and lesions and is mainly shared through direct physical contact, though the CDC warns it can also be transmitted via respiratory secretions during prolonged, face-to-face contact.

According to a news release, the new assay leveraged the BD Max system open system reagent suite to develop the CerTest Viasure monkeypox molecular…

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BD and CerTest Biotec team up on molecular monkeypox diagnostic test

A lab worker prepares samples for the BD Max system. [Photo courtesy of BD]Becton, Dickinson and Co. and CerTest Biotec announced a partnership to develop a molecular diagnostic test for the monkeypox virus.

The CDC is tracking a monkeypox outbreak in the United States and other countries that don’t normally report cases of the infectious virus, which causes a rash and lesions. Monkeypox has been shown to be fatal in up to 10% of cases in Africa.

A “testing bottleneck” may be jeopardizing the ability to contain the virus, experts warned this week.

Get the full story at our sister site, Medical Design & Outsourcing.

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BD and CerTest Biotec team up on molecular monkeypox diagnostic test

A lab worker prepares samples for the BD Max system. [Photo courtesy of BD]

Becton, Dickinson and Co and CerTest Biotec announced a partnership to develop a molecular diagnostic test for the monkeypox virus.

The CDC is tracking a monkeypox outbreak in the United States and other countries that don’t normally report cases of the infectious virus, which causes a rash and lesions. Monkeypox has been shown to be fatal in up to 10% of cases in Africa.

A “testing bottleneck” may be jeopardizing the ability to contain the virus, experts warned this week.

The automated BD Max platform’s open system reagent suite will validate the CerTest Viasure Monkeypox CE/IVD molecular test, BD said in a news release.

The Monkeypox PCR Detection Kit for the BD MAX system will be offered in a lyophilized format. The test will come in a tube that snaps into the test-specific position on the…

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