BD Enters High-Growth Molecular POCT Market with Elience Platform and CT/GC Assay

The system is calledBD Elience MoleculePOCTPlatform, filling a gap in the company's successful molecular testing business, which to date has mainly included medium to high-throughput laboratory instruments such as BD Max, BD Viper LT, and BD Cor.

During a conference call with investors, BD CEO Tom Polen stated that the company anticipates submitting the 510(k) application for the BD Elience system and its first assay within this fiscal year. As part of this process, BD has initiated clinical trial enrollment to evaluate the platform, Polen said.

He said, "In our first assay, a rapid CT/GC test for office-based testing and treatment, BD Elience enables BD to enter the high-growth molecular POCT market."

BD's laboratory molecular testing performed well in the first quarter, and Polen noted that the company continues to "view molecular diagnostics as a strong growth catalyst."

During the teleconference, Dave Hickey, Executive Vice President and President of BD Life Sciences, said that the Elience system can detect targets within 15 minutes, similar to the timeframes of Abbott ID Now, Cepheid Xpert Xpress, and Roche Liat point-of-care molecular products.

"Hickey said, 'Obviously, the relevant testing is becoming decentralized towards the field and new care environments.' He added, 'Elience will be our entry into this high unit growth market.'"

He also pointed out that Elience will eventually obtain CLIA waiver for use in a variety of settings.

Hickey added that the company chose CT/GC (sometimes also referred to as CT/NG) as its first test item, partly because of sexually transmitted infections (STIs) is increasing. He said, "This will increase access to testing."

Polen stated that CT/GC testing also meets the current unmet need for accurate technologies capable of serving the "test and treat" care model.

Regarding Elience's future menu, Hickey said: "We see a strong roadmap with a primary focus on respiratory testing, other STI testing, and vaginitis."

The CT/GC field is being actively pursued by many smaller diagnostic developers.

In 2019, Binx's io system and a CT/NG test received FDA clearance and CLIA waiver, marking the opening of the point-of-care STI testing space. Companies such as Detect, Sherlock Biosciences, Cue Health, Novel Microdevices, Lucira Health (recently acquired by Pfizer), and Aptitude Medical have also announced their intentions to enter the point-of-care STI testing market. Visby Medical's 30-minutePCRThe test has received FDA clearance and CLIA waiver for the detection of CT/NG and the sexually transmitted parasite Trichomonas vaginalis, while QuidelOrtho is developing a multiplex STI panel for its recently approved Savanna point-of-care PCR system.

BD's molecular POCT platform development began in 2020 with the acquisition of NAT Diagnostics, a company with patented core technology involving the use of real-time fluorescent molecular detection and novel enzymes.

NAT Dx has a history in the isothermal on-site molecular world. The company's founders, Andrew Miller and Honghua Zhang, previously led Ionian Technologies and invented the isothermal nucleic acid amplification technology known as Nicking Enzyme Amplification Reaction, or NEAR. Another co-founder of Ionian, David Galas, also invented Exponential Amplification Reaction, or EXPAR. Ionian's NEAR technology has been incorporated into Alere i, which has now become the Abbott ID Now system.

Financial First Quarter Report:

BD reported on Thursday that its revenue for the fiscal first quarter grew by approximately 3%, partly due to its broad product portfolio and ongoing simplification initiatives.

In the quarter ended December 31, 2023, BD reported revenue of $4.71 billion, up from $4.59 billion in the first quarter of fiscal year 2023, and slightly below Wall Street's estimated $4.73 billion.

In the fiscal first quarter, BD's Life Sciences segment revenue decreased by 1% to $1.29 billion, down from $1.3 billion. Within the Life Sciences segment, revenue from Integrated Diagnostic Solutions fell by 4% to $913 million, down from $952 million, while Biosciences revenue grew approximately 7% to $375 million, up from $349 million.

The performance of integrated diagnostic solutions reflected a comparison with respiratory testing revenue from the same period last year, BD stated, which was partially offset by high single-digit growth in the microbiology platform and strong double-digit growth in molecular IVD assays utilizing the installed base of BD COR systems and BD Max systems.

The company had cash and cash equivalents of $1.18 billion and restricted cash of $54 million at the end of the quarter.

BD Company stated that it is raising the midpoint of its guidance for fiscal year 2024. It now expects full-year revenue to be in the range of approximately $20.2 billion to $20.4 billion, compared to the previous expectation of $20.1 billion to $20.3 billion. It also anticipates organic revenue growth to be between 5.5% and 6.25%, compared to the prior forecast of 5.25% to 6.25%.

BD Raises FY24 Earnings Guidance; Adjusted Diluted EPS Now Expected to Be $12.82 to $13.06 vs. Prior Outlook of $12.70 to $13.00

In Thursday's early Nasdaq trading, the share price of BD fell approximately 2% to $234.93.