FDA Re-Opens Pre-Submission Requests for Non-COVID-19 IVD Tests
The agency is once more accepting pre-submissions for all in vitro diagnostic tests, not just those for COVID-19.
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Quest and Color Health Join CDC to Promote Equitable COVID-19 Testing
In July, ICATT took a major step toward equitable access to testing by enlisting two of the country’s leading COVID-19 PCR test providers.
Fate of Illumina’s Grail Acquisition Remains Very Much in Doubt
It’s beginning to look like Illumina’s roll of the dice is going to come up snake eyes regarding the potential acquisition.
Who Got the Early Jump on the Monkeypox Lab Tests Market?
Companies are using the lessons learned from COVID-19 to get out of the box quickly in developing test kits for monkeypox.
FY 2022 Q1 Could Be the Last Hurrah for the COVID Earnings Surge
Most diagnostics companies experienced modest, flat, or negative top-line revenue growth rates in the first quarter of 2022.
Precision Oncology Company Nabs Coverage for Advanced Cancer Test
In this month’s Business Roundup, we cover key happenings including Medicare coverage and reimbursement, as well as the US surpassing Europe as medtech’s market of choice.
Healthcare M&A Deal Volume & Size Bottom Out in First Quarter
Healthcare M&A might have bottomed out in the first quarter of 2022 in terms of both deal volume and size, according to a new report.
FDA Issues First Approval for SARS-CoV-2 Breathalyzer Test
InspectIR COVID-19 device detects the virus from breath samples in less than three minutes, offering a new screening option.
Onco Pharma Giants Team Up to Boost Access to Cancer Genomic Testing
The recently-formed Precision Cancer Consortium will make it easier for cancer patients around the world to get access to genomic testing.
CMS Highlights Threat of Healthcare Consolidation
The HHS recently published previously confidential data relating to consolidation of hospitals and nursing homes enrolled in Medicare.
EUA COVID-19 Tests to Remain on US Market After PHE Expires
The FDA has plans to ensure COVID-19 test makers won’t be left high and dry when the public health emergency ends.
The Craze Is Over but Healthcare SPAC Deals Remain Alive and Well
A hot trend in capital raising for the healthcare and life sciences industries only two years ago, SPAC deals have petered out, but are far from dead.
Global Aspiration & Biopsy Needles Market to See Strong Growth
According to a recent report, this market will see almost seven percent annual growth over the next five years, reaching US $1.29 billion in 2026.
