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BD (BDX) Product Gets FDA Nod, Patient Outcome to Get a Boost

Becton, Dickinson and Company BDX, popularly known as BD, recently received the 510(k) clearance from the FDA for the BD Kiestra IdentifA system. The system has been developed to automate the preparation of microbiology bacterial identification testing.

The BD Kiestra IdentifA is the only FDA-cleared solution currently available as part of a track-connected system for lab automation to support specimen preparation workflows for routine and challenging isolate types.

The latest regulatory approval is expected to significantly strengthen BD’s foothold in the global Integrated Diagnostic Solutions business, which is a part of the broader Life Sciences arm.

Significance of the Approval

Currently, identification of the microorganism that is causing an infection is a labor-intensive process. To simplify this, lab technicians will be able to use BD Synapsys informatics with the BD Kiestra IdentifA to select discrete bacterial colonies from a digital plate image. These selected organisms can then be physically picked by sophisticated robotics to prepare the sample for specific identification testing.

The BD Kiestra IdentifA system will likely transform the manual workflow into a standardized, automated and digitized process. This, in turn, is expected to reduce the potential for human error while preparing samples for bacterial identification, thereby producing more accurate diagnoses.

The integration of the BD Synapsys Informatics solution with the BD Kiestra IdentifA, in combination with matrix-assisted laser desorption/ionization-time of flight (MALDI-ToF) mass spectrometry, is expected to produce more rapid and accurate identification of bacteria and yeasts to aid clinician treatment decisions.

Per management, mass spectrometry methods, including MALDI-ToF technology, have innovated and advanced microbial identification in clinical microbiology, but often necessitate lengthy process steps and hands-on time. The BD Kiestra IdentifA system, which uses automated colony picking and MALDI-ToF spotting to lower time to pathogen identification, is expected to improve patient management.

Industry Prospects

Per a report by MarketsandMarkets, the global microbial identification market was estimated to be $3.2 billion in 2020 and is anticipated to reach $5.7 billion by 2025 at a CAGR of 12.2%. Factors like the rising incidence of infectious diseases and increasing frequency of pandemics, technological advancements, and growing food safety concerns are likely to drive the market.

Given the market potential, the latest FDA clearance is expected to significantly strengthen BD’s business worldwide.

Recent Developments in Life Sciences Arm

Of late, BD has witnessed a few notable developments across its Life Sciences segment.

In December 2021, BD completed the acquisition of privately held Scanwell Health Inc. BD’s management believes that the acquisition will enable the company to expand and scale up its digital capabilities in-house in order to speed up the time to market transformative at-home solutions at present as well as in the future.

The same month, the company announced that the BD Veritor At-Home COVID-19 Test is now available for purchase through Everly Health, Southeastern Grocers (parent company of Fresco y Más), Harveys Supermarket and Winn-Dixie stores. The test is also available for purchase on

Also in December, BD announced that it has expanded the BD COR System to include a new MX instrument for high-throughput molecular testing for infectious diseases.

Price Performance

Shares of BD have gained 1.8% over the past six months against the industry’s 0.02% fall and the S&P 500's 6.5% rise.

Image Source: Zacks Investment Research

Zacks Rank & Key Picks

Currently, BD carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are Laboratory Corporation of America Holdings LH or LabCorp, Henry Schein, Inc. HSIC and AMN Healthcare Services AMN.

LabCorp, sporting a Zacks Rank #1 (Strong Buy), has an estimated long-term growth rate of 10.6%. LH’s earnings surpassed estimates in the trailing four quarters, the average surprise being 25.73%. You can see the complete list of today’s Zacks #1 Rank stocks here.

LabCorp has gained 1.4% against the industry’s 0.02% fall over the past six months.

Henry Schein has an estimated long-term growth rate of 11.8%. HSIC’s earnings surpassed estimates in the trailing four quarters, the average surprise being 21.86%. It currently carries a Zacks Rank #2 (Buy).

Henry Schein has gained 2.5% against the industry’s 0.02% fall over the past six months.

AMN Healthcare has an estimated long-term growth rate of 16.2%. AMN’s earnings surpassed estimates in the trailing four quarters, the average surprise being 19.51%. It currently flaunts a Zacks Rank #1.

AMN Healthcare has gained 17.4% against the industry’s 32.1% fall over the past six months.

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