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Becton Dickinson to Submit Point-of-Care Molecular Dx System, STI Test to FDA This Year


This story has been updated from a previous version to correct an inaccuracy in the headline.

NEW YORK – Becton Dickinson announced on Thursday that it has begun clinical trials for a rapid point-of-care molecular diagnostics instrument and an assay to detect the sexually transmitted infections Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC). Executives said they expect to submit the system to the US Food and Drug Administration for 510(k) clearance and a CLIA waiver later this year. 

Called the BD Elience Point-of-Care Molecular Platform, the system fills a gap in the company's successful molecular testing business that so far has consisted of medium- to high-throughput, lab-based instruments like the BD Max, BD Viper LT, and BD Cor.

On a call with investors to review the firm's fiscal first quarter earnings, BD CEO Tom Polen said that the company anticipates its first 510(k) submission for the BD Elience system and its first assay this fiscal year. As part of this process, BD has initiated clinical trial enrollment for assessment of the platform, Polen said.

"In our first assay, a rapid CT/GC test for in-office testing and treatment, BD Elience enables BD to enter into the high-growth molecular point-of-care market," he said.

BD's lab-based molecular testing performed well in Q1, and Polen noted that the firm continues "to see molecular diagnostics as a strong growth catalyst."

On the call, Dave Hickey, executive VP and president of BD's Life Sciences segment, said the Elience system can detect targets in 15 minutes. This is a similar time frame to the Abbott ID Now, Cepheid Xpert Xpress, and Roche Liat point-of-care molecular offerings.

"Clearly, there is decentralization of relevant testing to the point-of-care and new care settings," Hickey said, adding that "Elience will be our entry in this high-single-digit [growth] market."

Elience will ultimately be CLIA-waived so that it can be used in a wide variety of settings, he also noted.

Hickey added that the company chose CT/GC, also sometimes called CT/NG, as its first assay due in part to the increasing burden of STIs. "It will increase access to testing," he said.

Polen said that the CT/GC test also meets a current unmet need for accurate technologies that can serve a "test-and-treat" care model.

In terms of a future menu for the Elience, Hickey said, "we see a strong roadmap behind it, focused on respiratory assays, other STI assays, [and] vaginitis."

The CT/GC space is being aggressively pursued by many smaller diagnostics developers.

The point-of-care STI testing space was inaugurated in 2019 with the FDA clearance and CLIA waiver of the io system from Binx and a test for CT/NG. Firms such as DetectSherlock BiosciencesCue HealthNovel MicrodevicesLucira Health (recently acquired by Pfizer), and Aptitude Medical have also declared their intent to enter the point-of-care STI testing market. A 30-minute PCR test from Visby Medical is FDA-cleared and CLIA-waived to detect CT/NG and the sexually transmitted parasitic amoeba Trichomonas vaginalis, while QuidelOrtho is developing a multiplex STI panel for its recently cleared Savanna point-of-care PCR system.

BD's point-of-care platform development kicked off when it acquired NAT Diagnostics in 2020, a firm with patented core technology that involves the use of real-time fluorescence molecular detection and novel enzymes.

NAT Dx had a legacy in the isothermal point-of-care molecular world. The company's founders, Andrew Miller and Honghua Zhang, were previously in charge of Ionian Technologies and invented the isothermal nucleic acid amplification technology Nicking Enzyme Amplification Reaction, or NEAR. Ionian's other cofounder, David Galas, also invented exponential amplification reaction, or EXPAR. The Ionian NEAR technology was incorporated into the Alere i, which has subsequently become the Abbott ID Now system.

Fiscal Q1 results

Becton Dickinson also reported Thursday that its fiscal first quarter revenues rose approximately 3 percent, attributed in part to its broad portfolio and ongoing simplification programs.

For the quarter ended Dec. 31, 2023, BD reported earnings of $4.71 billion, up from $4.59 billion in fiscal Q1 2023 and just below the Wall Street estimate of $4.73 billion.

In fiscal Q1, BD's Life Sciences segment revenues declined 1 percent to $1.29 billion from $1.30 billion. Within Life Sciences, Integrated Diagnostic Solutions revenues declined 4 percent to $913 million from $952 million, while Bioscience revenues increased approximately 7 percent to $375 million from $349 million.

The performance of Integrated Diagnostic Solutions reflects the comparison to higher prior-year respiratory testing revenues, BD said, and is partially offset by high-single-digit growth in microbiology platforms and strong double-digit growth from molecular IVD assays leveraging the BD COR System and BD Max System install base.

The Bioscience segment performance was driven by strong mid-single-digit growth in both research and clinical solutions, despite the impact of prior-year comparisons, BD also said. This performance was led by double-digit growth in research instruments enabled by the BD FACSDiscover S8 Cell Sorter and BD Rhapsody HT Xpress launches, and double-digit growth in clinical reagents was driven by the FACSLyric Clinical Cell Analyzer and FACSDuet Sample Preparation System install base.

BD's Medical segment revenues increased approximately 4 percent to $2.23 billion from $2.15 billion, while its Interventional segment revenues increased 5 percent to $1.19 billion from $1.13 billion. 

Revenues from the company's US business increased approximately 1 percent to $2.75 billion from $2.73 billion in the year-ago quarter, and revenues from international markets increased 6 percent to $1.96 billion from $1.86 billion.

During the quarter, BD received 510(k) clearance for its BD MiniDraw Capillary Blood Collection System, a device developed in partnership with Babson Diagnostics that enables fingertip collection of a high-quality blood sample. The firm also initiated a collaboration with the Kenyan government to advance access to critical cancer diagnostics for women there.

BD recorded net income for the quarter of $281 million, or $.96 per share, compared to net income of $509 million, or $1.70 per share, a year ago. On an adjusted basis, the company reported Q1 EPS of $2.68, beating the consensus Wall Street estimate of $2.40 per share.

The company finished the quarter with $1.18 billion in cash and cash equivalents and restricted cash of $54 million.

BD said it is raising the midpoint of its guidance for fiscal year 2024. It now expects full-year revenues to be in the range of approximately $20.2 billion to $20.4 billion compared to $20.1 billion to $20.3 billion previously. It also guided for organic revenue growth of 5.5 percent to 6.25 percent, compared to 5.25 percent to 6.25 percent previously.

BD also raised fiscal year 2024 EPS guidance to an adjusted diluted EPS of $12.82 to $13.06, compared to $12.70 to $13.00 previously. BD said this reflects an increase of $.09 at the midpoint, including an operational increase of $.07 driven by strong execution in the first quarter and a $.02 improvement related to foreign currency translation.

In Thursday morning trading on the Nasdaq, BD shares were down approximately 2 percent to $234.93.