Diagnostics Pipeline: 2024 Trends in FDA Approvals

According to one analyst, FDA approvals over the past year show a continued move toward rapid and point-of-care (POC) tests, as well as a sharp jump in approvals related to drug and substance abuse tests.

While potentially a boon to patient care, wider availability of these tests could have business ramifications for clinical labs that are already dealing with reduced reimbursements and higher operating costs.

Key trends in 2024 FDA IVD approvals

Reached via email, Selena Yu, senior medical analyst at data analytics and consulting company GlobalData, says, “the most common indication for IVD tests was drug/substance abuse tests.” One hundred and twenty such tests were approved in 2024, more than one-third of the total 340 IVD products Yu says the FDA approved in 2024 by the time of writing in early December. Analyzing historical data available from GlobalData, she adds that there were also 165 approvals for rapid tests and 54 POC test approvals in 2024, compared with just 10 approvals for rapid tests and 74 for POC tests in 2021.

2024 also saw a drop in COVID-19 test approvals, with a total of 93 approvals for COVID-19 tests, including multiplex options that also test for other respiratory diseases, compared with 132 approvals in 2021. All the data Yu provides is from GlobalData’s Medical Device Marketed Products Database. She adds that the biggest change from 2021 involved tests for drug and substance abuse.

“The biggest difference is that there were only 15 drug/substance abuse-related tests approved in 2021,” Yu points out. “This demonstrates a huge jump in recent years.”

IVD approvals that stood out

A couple of specific approvals stood out for Yu this year:  the abioSCOPE^® by Swiss company Abionic and the MI Cancer Seek™ companion diagnostic test (CDx) by Texas-based Caris Life Sciences.

The abioSCOPE is a POC device that gained FDA 510(k) clearance in September for use with Abionic’s IVD CAPSULE PSP immunoassay for early sepsis detection in high-risk patients.¹ Yu explains that, because sepsis develops quickly, the ability to test faster than traditional options, and at the patient’s bedside, is especially important.

“Typically, tests can take days to hours, so the abioSCOPE that can detect [sepsis] in about five minutes will give life-saving care to patients,” Yu says.

As for the Caris MI Cancer Seek CDx, which was approved in November,² Yu says the test intrigued her “because it’s a multifaceted CDx that uses whole exosome sequencing and whole transcriptome sequencing to find the best treatment for breast, colorectal, melanoma, non-small cell lung cancer, solid tumor, and endometrial cancer patients.”

The test looks at the PIK3CA, KRAS, and BRAF genes, as well as MSI-H level, as biomarkers to identify the best cancer treatment for each patient. The assay also monitors patient response to those treatments.

“This approach is the future of medicine in my opinion,” Yu says. “A customized care approach with patient monitoring is the ideal way to look at patient care, especially in complex and chronic illnesses like cancer.”

What do these trends mean for labs?

As for what 2024 trends mean for labs, Yu says the shift toward rapid and POC-based tests means less reliance on lab-based tests. On the positive side for lab leaders, this may reduce labs’ workloads, but on the downside, could mean less business as testing is shifted to the point of care.

For example, in a recent Today’s Clinical Lab article, laboratory director Tyler Radke, MLS(ASCP)CM, lists direct-to-consumer testing as a top threat for the clinical lab industry to watch in 2025. According to Radke, specific downsides to this type of POC testing include revenue being pulled away from community health care, lack of clinical relevance or need in orders for these tests, and improper follow-up on abnormal test results.³

However, Yu sees positives for patients in the move to POC testing.

“For end users, like patients and medical professionals, we can expect faster care,” she explains. “Patients can be treated quicker because testing occurs closer.” She adds that the shift to rapid tests will offer similar benefits, providing results quicker, thus helping patients to receive care faster, which can improve a patient’s prognosis.

A key hurdle to wider access to such tests, however, is the lack of reimbursement for POC tests, which Yu points out in a recent GlobalData blog.⁴

How will these trends continue to develop in 2025?

For 2025, Yu says that labs and other healthcare providers can expect to see an increase in liquid biopsy tests and genetic tests in oncology compared to last year. The GlobalData blog post also mentions six key areas for future IVD growth:

• cancer screening,
• sepsis,
• minimal residual disease,
• autoimmunity,
• neurology, and
• women’s health.

Yu adds in the same blog post that in addition to further increases in POC testing, further innovation in novel biomarkers and digital and AI integration into health care can be expected in 2025.

References:

1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240041
2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=P240010
3. https://www.clinicallab.com/top-threats-facing-the-clinical-laboratory-industry-in-2025-and-beyond-what-leaders-need-to-know-28043
4. https://www.globaldata.com/media/medical-devices/future-ivd-hinges-three-big-industry-themes-says-globaldata/
5. https://www.fda.gov/medical-devices/recently-approved-devices/2024-device-approvals

The FDA recently released its list of 2024 medical device approvals involving some of the latest technology. Though not including all products approved in 2024, the list provides a snapshot of innovation in the medical devices industry. Laboratory tests had a strong showing, making up roughly a third (28.6 percent) of the approvals featured in the list. Out of a total 28 products featured, eight were lab tests, the largest number of products from a single category. Most of these lab tests were for the detection of human papillomavirus (HPV), with three such products listed.⁵

2024 Lab Test Approvals That Included New Technology