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Quest Diagnostics (DGX) & Peers Progress With Monkeypox Testing

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Quest Diagnostics (DGX - Free Report) , just like its industry peers, is progressing in terms of monkeypox virus test development. While the FDA is going all out to increase monkeypox testing capacity and access across the United States, the company in September received FDA’s emergency use authorization (EUA) for its proprietary monkeypox test.

This came on the heels of the Department of Health and Human Services’ declaration (on Sep 7) to allow the FDA Commissioner issue a EUA for in-vitro diagnostics to expand the availability of tests for monkeypox. Following this, the FDA issued new guidance, outlining the agency’s current view regarding enforcement policies, recommendations for EUA requests for monkeypox diagnostic tests and its plans to prioritize the review of EUA requests.

Quest Diagnostics in its latest media report released on Sep 15 noted that demand for COVID-19 molecular diagnostic testing declined in August compared to the prior month. However, at the same time, its Monkeypox Virus Qualitative Real-Time PCR, being the first lab-developed test to get an EUA specifically for monkeypox virus DNA detection, should get huge market acceptance amid the ongoing public health emergency. We believe this should compensate the shortfall in testing demand in the coming days.

Here's How DGX Peers are Dealing With Monkeypox

QIAGEN N.V. (QGEN - Free Report) recently launched the QIAstat-Dx Viral Vesicular Panel RUO— the first syndromic test that can distinguish between monkeypox and five other pathogens causing similar symptoms. This launch is part of QIAGEN’s efforts to combat the spread of monkeypox, which has been recently declared a public health emergency by the World Health Organization (WHO) and the U.S. government.

This novel research use only (RUO) panel is available in cartridge form that can be run on QIAGEN’s QIAstat-Dx automated syndromic testing devices. The panel’s RUO status indicates that it can only be used for the surveillance of monkeypox cases at present and not for screening or diagnostics purposes. However, the company is prepared to make applications for clinical use if authorities in the United States and the European Union open new diagnostic pathways in response to the public health emergency.

Laboratory Corporation of America Holdings (LH - Free Report) , popularly known as LabCorp, initiated monkeypox testing. This test is performed using the U.S. Centers for Disease Control and Prevention’s (CDC) orthopoxvirus test, which detects all non-smallpox-related orthopoxviruses, including monkeypox. According to LabCorp, this effort is part of the CDC’s commitment to quickly increase monkeypox testing access and capacity in every community during the ongoing outbreak.

This test for monkeypox has the ability to accept specimens from LabCorp customers as well as overflow from public laboratories across the United States using its significant transportation and logistics capabilities. LabCorp earlier expected to increase capacity to up to 10,000 tests per week, doubling the current capacity provided through CDC's Laboratory Response Network (LRN).

Meanwhile, Becton, Dickinson and Company (BDX - Free Report) or BD and CerTest Biotec in late September announced that their newly developed molecular polymerase chain reaction assay for monkeypox virus is now commercially available globally, including in the United States, for research use only applications by laboratories. BD is currently working to submit a clinical test for the monkeypox virus for emergency used authorization as soon as possible, based on the guidance issued by the FDA on Sep 7.

Industry Prospects

Going by a Data Bridge Market Research analyses report, the monkeypox market is expected to witness significant growth during 2022-2029. The expected CAGR of the global monkeypox market is around 5.40% for the forecast period.

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