New York - BD announced on Thursday the start of clinical trials for a rapid point-of-care molecular diagnostic 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 U.S. Food and Drug Administration later this year.510(k) Clearance and CLIA Waiver.

The system isCalledBD Elience Molecular POCT Platform, 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 said the company expects to file its first 510(k) application for the BD Elience system and its initial 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 reagent, 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, Polen noted, and the company continues to "View molecular diagnostics as a powerful growth catalyst。”

During the teleconference, Dave Hickey, Executive Vice President and President of BD Life Sciences, said,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.

HikySaid, "Clearly, 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,Elience will eventually receive CLIA waiver for use in a variety of settings.

Hickey added that the company chose CT/GC (sometimes referred to as CT/NG) as its first test, partly due to the growing burden of sexually transmitted infections (STIs). "This will improve access to testing," he said.

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

Regarding Elience's future menu, Hickey said: "We see a strong roadmap,Mainly focus on respiratory tract 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 approval.CLIAExemption, marking the opening of the on-site STI testing space. Like Detect,Sherlock BiosciencesCue Health, Novel Microdevices, Lucira Health (recently acquired by Pfizer), and Aptitude Medical, among others, have also announced their entry into the point-of-care STI testing market. Visby Medical's 30-minute PCR test has already received FDA clearance and CLIA waiver for the detection of CT/NG and sexually transmitted parasites such as Trichomonas vaginalis.Trichomonas, while QuidelOrtho is developing a multiplex STI panel for its recently licensed 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 founderAndrew MillerHonghua 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 the Alere i, which has now become part of the Abbott ID Now system.

Financial First Quarter Report:

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

In the quarter ended December 31, 2023,BD Reports Revenue of $4.71 BillionHigher than the $4.59 billion in the first quarter of fiscal year 2023, but slightly lower than the Wall Street estimate of $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 declined 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 Outlook: Adjusted Diluted EPS Now Expected to Be $12.82 to $13.06 vs Prior $12.70 to $13.00

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

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