The federal employee firings in the news have landed on a possible impact area for in vitro diagnostics, with reports of layoffs at FDA and more specifically, at CDRH. The Center for Devices and Radiological Health (CDRH) regulates IVDs, also imaging and other devices, as well as software.
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.
Given that in vitro diagnostics 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. This is true even for established players.
Letters have encouraged employees to “seek employment in the private sector.”
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.”
https://www.raps.org/news-and-articles/news-articles/2025/2/firing-of-fda-probationary-staff-creates-widesprea
In private moments, at conference talks, IVD industry innovators might be heard 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 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. This does not necessarily mean the industry will rejoice over a sudden employee reduction. 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.
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 e(“Today, inpatient bed use rates are not far from what they were during the winter of 2022.”) plus funding issues.”House Republicans have 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, 30% in Alaska.
Not a good combo, if present trends continue. Info on percentage of hospital Medicad funding by state: https://www.definitivehc.com/resources/healthcare-insights/hospital-payor-mix-state
ROCHE GETS CLIA-WAIVER FOR PANEL INCLUDING MG: Roche Liat STI Tests recent approval. sexually transmitted infections (STIs) continue to pose a widespread but often overlooked public health threat. 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, further emphasizing the need for accessible and reliable diagnostic solutions.
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 persons with urogenital symptoms and in those who attend clinics providing sexual health services (22–24). The prevalence of M. genitalium is similar to that of chlamydia and exceeds that of Neisseria gonorrhoeae (14). https://pmc.ncbi.nlm.nih.gov/articles/PMC10035321/
Roche has also made strides in STI diagnostics with the recent 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.
BIOMERIEUX GI PANEL: In its recent appearance at JPM indicated it would be targetting non-respiratory panels as a way for growth to supplment the increasingly competitive respiratory panel market. 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.
- Bacteria: Campylobacter (C. jejuni/C. coli/C. upsaliensis), Clostridioides (Clostridium) difficile (toxin A/B), Salmonella, Vibrio (V. parahaemlyticus/V. vulnificus/V. cholerae), Yersinia enterocolitica, Shiga-like toxinproducing E. coli (STEC) stx1/stx2, Shigella/Enteroinvasive E. coli (EIEC).
- Viruses: Norovirus GI/GII
- Parasites: Cryptosporidium, Cyclospora cayetanensis, Giarda lamblia
ROCHE GETS CLEARANCE ON LP(A): Roche Lp(a) Lipoprotein(a) [Lp(a)] is similar to LDL (“bad cholesterol”) but includes apolipoprotein(a), increasing the risk of cardiovascular disease (CVD), heart attacks, and strokes. Lp(a) levels are largely inherited and remain relatively stable throughout life. Unlike LDL cholesterol, Lp(a) levels are not significantly lowered by diet, exercise, or most common cholesterol-lowering medications like statins. In another significant development, Roche has secured FDA 510(k) clearance for the first blood test in the U.S. that measures lipoprotein (a), or Lp(a), in molar units. Approximately one in five people worldwide have elevated Lp(a) levels, a genetic risk factor associated with cardiovascular diseases such as heart attack and stroke. The Roche Diagnostics Tina-quant® Lipoprotein (a) Gen.2 Molarity assay offers a more accurate measurement of Lp(a) levels, allowing physicians to better assess cardiovascular risk. As new treatments targeting Lp(a) emerge, this test will provide valuable insights for identifying at-risk individuals and guiding clinical decisions. The assay will be broadly available on Roche’s chemistry systems in the U.S.
COLOR HELPS SMARTPHONE TEST: Correcting color on smartphones doesn’t seem like a medical problem, but it has blocked potentially useful spectroscopy technology. HemaChrome LLC, a digital health startup in collaboration with Purdue University and Global Health Labs Inc. (GH Labs), has developed a patented method to enhance color accuracy in smartphone images. One of the biggest challenges in mobile diagnostics has been the distortion of colors in digital photographs, which can impact the reliability of clinical assessments. HemaChrome’s machine learning-based technology uses spectroscopy and computational algorithms to extract true colors from digital images, effectively transforming a smartphone or computer camera into a hyperspectral imager. This breakthrough enables the instant and noninvasive measurement of blood hemoglobin levels from a digital photo of the inner eyelid. The innovation opens up new possibilities for point-of-care, home-based, and remote diagnostic testing at a significantly lower cost than traditional methods.
BIO RAD PICKS UP HIGH THROUGHPUT DPCR MAKER – On February 13, Bio-Rad Laboratories announced a binding offer to acquire all equity interests in Stilla Technologies for up to $275 million. Stilla, with operations in France and the U.S., specializes in developing next-generation digital PCR (Polymerase Chain Reaction) instruments, consumables, and assays. Their flagship product, the Nio® family of all-in-one digital PCR systems, supports the development of various genetic tests and molecular assays across applications such as oncology diagnostics, cell and gene therapy, organ transplant testing, infectious diseases, and food and environmental testing.
Stilla’s Nio® digital PCR system is a high-throughput platform designed for efficiency and flexibility. It supports up to seven fluorescent channels, enabling the simultaneous detection and quantification of multiple targets, surpassing many existing systems. With the ability to continuously load up to eight chip plates, each accommodating 48 samples, it can process up to 768 samples in an eight-hour workday. Its user-friendly workflow minimizes hands-on time to about five minutes per run, with results available in approximately 2.5 hours. Unlike systems that require separate instruments for droplet generation, thermal cycling, and detection, the Nio® integrates all these functions into a single, compact unit, reducing the equipment footprint and simplifying workflows. The ability to add samples without interrupting ongoing runs enhances flexibility and maximizes instrument utilization, making it well-suited for high-throughput laboratory environments.
