Monkeypox is the latest disease showing up in the United States. That means hospital laboratories will want to be ready to diagnose monkeypox cases that show up in their emergency departments. An official from the Centers for Disease Control and Prevention (CDC) says it is exploring the possibility of expanding capacity for monkeypox testing if it becomes necessary. Currently, a state or local laboratory performs an initial test to determine if a case is an orthopox virus (the genus that includes monkeypox) and a CDC laboratory later confirms whether it is monkeypox, according to STAT.
MORE ON: Monkeypox Testing Capacity
At least two in vitro diagnostics companies are preparing to meet any increased demand for monkeypox testing. Roche announced on May 27 that it had rolled out a new suite of tests to detect the monkeypox virus and that the tests are available in most countries. Meanwhile, CNN reported that Abbott Labs plans to introduce a polymerase chain reaction test for monkeypox. As of June 1, 19 monkeypox cases had been detected in the U.S., according to the CDC. The disease is rare in this country, so the increase in cases is puzzling. The CDC reported two monkeypox cases in the U.S. in 2021.
CDRH RESUMES IVD PRE-SUBMISSIONS
It was good news for lab test developers when, as of June 1, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) began accepting non-COVID-19-related in vitro diagnostic (IVD) pre-submissions. Since April 2021, the CDRH had declined some pre-submission requests as it sought to prioritize pandemic work, according to MedTech Dive. Due to the continued elevated workload related to the pandemic, it’s likely that upcoming IVD pre-submissions will initially be reviewed under an extended timeline, CDRH noted.
• XIFIN has appointed John Kelly as the company’s first Chief Information Officer (CIO). He comes after stints as Chief Technology Officer (CTO) at software company PatientKeeper and as a Segment CIO and CTO at Cigna.
• Sharon Bracken is the new Head of Diagnostics at Siemens Healthineers. Bracken was most recently President at Perma Pure, a moisture management company. She previously spent 14 years at Abbott and four years at Ortho Clinical Diagnostics.
• Funda Suer, PhD, has joined Quadrant Biosciences as Executive VP of Clinical Diagnostics and CLIA Laboratory Director. Suer previously served as Division Head of Molecular Diagnostics at Sema4 and Lab Director at the Icahn School of Medicine at Mt. Sinai.
That’s all the insider intelligence for this report. Look for the next briefing on Monday, June 27, 2022.