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BD Gets 510(k) Clearance for Its FACSLyric Flow Cytometer

Zacks Equity Research
·4 min read

Becton, Dickinson and Company BDX, also popularly known as BD, recently received 510(k) clearance from the FDA for its FACSLyric Flow Cytometer with the Integrated BD FACSDuet Sample Preparation System. Notably, the BD FACSDuet Sample Preparation System adds new capabilities to the BD portfolio of clinical flow cytometry solutions, which provide a pre-analytical system and together with the BD FACSLyric Flow Cytometer is the first complete walkaway sample-to-answer solution for clinical labs.

Notably, the BD FACSDuet Sample Preparation System offers an enhanced level of performance that helps clinical labs to augment their pace. The BD FACSDuet, which has been developed to complement and combine with the BD FACSLyric Flow Cytometer, also bolsters flexibility and standardization.

This approval is likely to provide a boost to BD Biosciences, which is part of BD Life Sciences business.

Significance of the 510(k) Clearance

It is important to mention here that flow cytometry in the clinical lab is a complicated procedure, which involves multiple workflows and manual steps, and requires lean and effective technologies that can lower lab costs, improve quality and limit error rates.




The new integrated system allows clinical laboratories to fully automate the sample to answer process and boost their efficiency by lowering errors and limiting manual user interventions necessary to run assays on the BD FACSLyric Flow Cytometer. Automation solutions for flow cytometry such as the BD FACSDuet and BD FACSLyric ultimately leads to improvement in throughput while offering consistent results that clinicians rely on to make informed decisions associated with patient care.

Notably, the BD FACSLyric Flow Cytometer with the integrated BD FACSDuet Sample Preparation System is now available as an in vitro diagnostic (IVD) system in the United States and countries considering the CE-IVD certification, which was achieved in March 2019.

Market Prospects

Per a report by Grand View Research, the global flow cytometry market was worth $3.98 billion in 2018 and anticipated to witness a CAGR of 10.6% over the forecast period (2019-2026). Hence, the clearance is well-timed for BD.

Recent Development

This month, BD received CE mark for its rapid, point-of-care, SARS-CoV-2 antigen test for utilization on the BD Veritor Plus System. The new test brings in substantial improvement in turnaround time for COVID-19 diagnostics as it offers real-time results and helps in making decisions while the patient is still onsite.

Price Performance

Over the past year, shares of this Zacks Rank #3 (Hold) company have lost 4.6% against the industry’s 9.3% rally.

Stocks to Consider

Some better-ranked stocks from the broader medical space include Biolase, Inc. BIOL, Boston Scientific Corporation BSX and Thermo Fisher Scientific Inc. TMO. While both Biolase and Boston Scientific carry a Zacks Rank #2 (Buy), Thermo Fisher sports a Zacks Rank of 1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Biolase has a projected long-term earnings growth rate of 15%.

Boston Scientific has an estimated long-term earnings growth rate of 10%.

Thermo Fisher has a projected long-term earnings growth rate of 15.5%.

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Becton, Dickinson and Company (BDX) : Free Stock Analysis Report
 
Boston Scientific Corporation (BSX) : Free Stock Analysis Report
 
Thermo Fisher Scientific Inc. (TMO) : Free Stock Analysis Report
 
Biolase, Inc. (BIOL) : Free Stock Analysis Report
 
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