FDA Layoffs, Hurting Hospitals, New Roche and bioMérieux Tests
Bruce Carlson
Eye on IVD LLC. Former Head of Kalorama Information. Market Research Consultant and Publisher.
The federal employee firings in the news have landed on a possible impact area for in vitro diagnostics, with reports of layoffs at the FDA and, more specifically, at CDRH, The Center for Devices and Radiological Health. This is the part of FDA that regulates IVDs, imaging, and other devices, as well as software, and reports seem to note CDRH taking more of a hit than other areas.
The effects of the layoffs of probationary employees on the in vitro diagnostics industry are unclear, but fewer employees at the agency should, logic must portend, increase review times and thus decrease clearance time. That is unless other regulations are changed or applications are fast-tracked through a yet-to-be-announced policy. So far, only the employee reduction has been announced.
In private moments...IVD industry innovators might be heard expressing frustration at regulation...this does not mean that the industry will rejoice over a sudden employee reduction, especially if it adds uncertainty to the review process.
Given that in vitro diagnostics companies and industry associations lobby for more reviewers and faster reviewer times, this must, until proven otherwise, be seen as a negative. IVD relies on fresh product introductions and approvals to accommodate customer-friendly tweaks and scientific discoveries.
Letters have encouraged employees to “seek employment in the private sector.” For those companies seeking regulatory-knowledgeable people, there is likely to be a larger pool.
Regulatory Focus quotes Jay Vaishnav, director of regulatory affairs at Canon Medical Informatics and a former associate director at the Center for Devices and Radiological Health (CDRH), “I am concerned about the loss of talented people with specialized training.
“Review work is complex and highly technical, and training a good reviewer takes a long time–about two years,” she added. “I am also concerned about the loss of research scientists, whose work informed complex reviews.”
In private moments, at conference talks, IVD industry innovators might be heard expressing frustration and speculating about a future where regulation is reduced. It is common to contrast the exhaustive FDA approval process to Europe’s CE Mark, which is largely run by government-blessed trade members and, in many cases, able to put products on the market faster (though there remains looming IVD approval changes in Europe). It is common to speak of, particularly with new genetic tests or recently discovered biomarkers, a need for faster approvals in the US for better outcomes to save lives.
Yet, this does not mean that the industry will rejoice over a sudden employee reduction, especially if it adds uncertainty to the review process. If the steps are quickly (and it would have to be quickly) accompanied by some regulatory reduction or fast-tracking, the picture might be clearer.
UPDATE (2/20) - STAT notes that AvaMed has indeed complained about FDA employee cuts, noting that many positions are funded by device fees.
Device review times were already too long, though they were improving as the result of our latest user-fee agreement"
FREE AI WEBINAR - What's the real future of IVD and AI? Not the future an AI company tells us will come. Greg Powell has been looking at IVD markets for 30 years. Don't forget to sign up for our webinar with Greg Powell of Howe Sound Research. https://us06web.zoom.us/webinar/register/WN_RpmYgJtFS_qbg5HZNEZfEg
HURTING HOSPITALS? Among the largest buyers of in vitro diagnostic systems and supplies are hospitals, and assessing their health is always a good way to read the health of the market for IVDs. Becker’s does not have good news: capacity issues (“Today, inpatient bed use rates are not far from what they were during the winter of 2022.”) plus funding issues. https://www.beckershospitalreview.com/finance/hospital-ceos-prep-for-devastating-medicaid-cuts.html "[House leadership has] introduced a budget plan that proposes $2 trillion in mandatory spending cuts. Of this, $880 billion is allocated to reductions under the Energy and Commerce Committee, a move that is likely to impact Medicaid.”
Medicaid could be 15% of US hospital revenue, though it varies by state: 10%, for instance, in California, and 30% in Alaska.
It's not a good combo if present trends continue. Info on the percentage of hospital Medicaid funding by state: https://www.definitivehc.com/resources/healthcare-insights/hospital-payor-mix-state
ROCHE GETS CLIA-WAIVER FOR PANEL INCLUDING MG: Every day, more than one million people worldwide contract an STI, with many cases going undiagnosed due to absent or overlapping symptoms. Among the most common infections are Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG), both of which can lead to severe complications if untreated.
Additionally, Mycoplasma genitalium (MG) is emerging as a concerning STI affecting both men and women, low in the population but high among those who seek treatment. And it is the -focus of a new Roche test on the company's molecular point-of-care system.
MG’s extremely slow growth in vitro and very demanding culture requirements necessitate the use of molecular-based diagnostic tests for its detection in clinical specimens.
M. genitalium is typically detected in the lower urogenital tract of about 1% to 6.4% of men and women in the general population (16, 18–22). However, it has a much higher prevalence (sometimes exceeding 20%) in those who attend clinics providing sexual health services (22–24). More info here: https://pmc.ncbi.nlm.nih.gov/articles/PMC10035321/
Roche received FDA 510(k) clearance and CLIA waiver for its cobas liat STI multiplex assay panels. These panels provide clinicians with the ability to diagnose and differentiate multiple STIs, including chlamydia, gonorrhea, and Mycoplasma genitalium, using a single patient sample. The tests will soon be available in the U.S. market, with commercialization under the CE mark anticipated shortly thereafter.
NEW BIOMERIEUX GI PANEL: In its recent appearance at JPM 2025, bioMérieux indicated it would be targeting non-respiratory panels as a way for growth to supplement the increasingly competitive respiratory panel market.
That didn't take long.
This month, bioMérieux has received FDA clearance for its BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid, a PCR-based test that simultaneously detects 11 pathogens directly from stool samples of patients with GI symptoms. Designed for use on bioMérieux’s BIOFIRE FILMARRAY 2.0 and Torch PCR platforms, the panel requires only two minutes of hands-on setup time, with results available in approximately one hour.
This test complements the company’s existing high-plex BIOFIRE? GI Panel, which has been available since 2014 and detects 22 pathogens. The new mid-range panel offers a streamlined workflow for laboratories while maintaining rapid and comprehensive diagnostic capabilities. BIOFIRE? Gastrointestinal (GI) Panel Mid is expected to be commercially available in the U.S. by mid-2025.
Diseases on the panel include:
High growth in other panel tests and less competition for the GI space justifies the GI panel strategy. Per NIH, there are 54 million visits annually to ambulatory care for GI disease-related complaints.
Other News
ROCHE GETS CLEARANCE ON LP(A) TEST:
COLOR HELPS SMARTPHONE TEST:
BIO-RAD PICKS UP HIGH THROUGHPUT DPCR MAKER
More at www.eyeonivd.com
Technology Development, POC, IVD
2 周Thank you for the very informative newsletters !