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PerkinElmer's (PKI) Reagent Kit Receives FDA Clearance

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PerkinElmer, Inc.’s (PKI - Free Report) Oxford Immunotec recently announced that the FDA approved the use of the T-Cell Select reagent kit to automate its T-SPOT.TB test workflow for in-vitro diagnostic (IVD) use by certified laboratories. The T-Cell Select reagent kit is currently available across Europe where CE marking is accepted, South Korea and China, and is rapidly becoming available in more markets worldwide.

The T-SPOT.TB test is a globally regulated ELISPOT IGRA for detecting latent TB infection. Also, the test with the T-Cell Select reagent kit is currently the only automated IGRA TB test without regulatory (label) warnings for immunocompromised patients, who often have lower levels of T cells available to assess.

The latest regulatory approval is likely to aid PerkinElmer in significantly solidifying its foothold in the global IVD space and boosting its Diagnostics business.

Significance of the Approval

The T-Cell Select reagent kit allows for a more automated workflow, which has been designed to lessen the time spent by lab personnel and lower overall costs. The increased use of automation also improves blood sample logistics as it extends the period for which collected blood can be stored at room temperature. Thus, this extended blood sample stability enables easy centralization of sample processing, thereby expanding access to the T-SPOT.TB test and giving laboratories more flexibility to operate.

Per management, automation is expected to close the gap between ELISPOT and ELISA laboratory workflows and enable more laboratories to offer the clinically superior T-SPOT.TB test to more physicians. This will likely enable PerkinElmer to provide the best quality of care for the most susceptible patients across the United States.

Industry Prospects

Per a report by MarketsandMarkets, the global IVD market is anticipated to reach $113.1 billion by 2026 from $98.2 billion in 2021 at a CAGR of 2.9%. Factors like the rising elderly population and the subsequent growth in the prevalence of chronic and infectious diseases, and increasing adoption of fully automated and point of care instruments are likely to drive the market.

Given the market potential, the latest regulatory approval is likely to provide a significant boost to PerkinElmer’s business globally.

Notable Developments

Last month, PerkinElmer announced second-quarter 2022 results, registering a solid non-COVID organic growth. During the reported quarter, the company entered into an agreement with the intention to divest its Applied, Food and Enterprise Services businesses to New Mountain Capital. The transaction, subject to regulatory approvals and other customary closing conditions, is expected to close in the first quarter of 2023.

In July, PerkinElmer announced that a placental growth factor (PlGF) measurement using its DELFIA Xpress PlGF 1-2-3TM kit (CE-IVD) and a soluble fms-like tyrosine kinase 1 (sFlt-1)/PlGF ratio using its DELFIA Xpress sFlt-1 kit (CE-IVD), have been included in an updated diagnostic guidance issued by the UK’s National Institute for Health and Care Excellence to help diagnose suspected preterm pre-eclampsia.

PerkinElmer, in June, launched the GC 2400 Platform, an advanced, automated gas chromatography (GC), headspace sampler and GC/mass spectrometry (GC/MS) solution designed to help lab teams simplify lab operations, drive precise results and perform more flexible monitoring.

Price Performance

Shares of the company have lost 32.6% in the past year compared with the industry’s 32.4% decline and the S&P 500's 16.9% fall.

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Zacks Rank & Key Picks

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

Some better-ranked stocks in the broader medical space are AMN Healthcare Services, Inc. (AMN - Free Report) , ShockWave Medical, Inc. (SWAV - Free Report) and McKesson Corporation (MCK - Free Report) .

AMN Healthcare, flaunting a Zacks Rank #1 (Strong Buy) at present, has an estimated long-term growth rate of 3.2%. AMN’s earnings surpassed the Zacks Consensus Estimate in all the trailing four quarters, the average beat being 15.7%.

You can see the complete list of today’s Zacks #1 Rank stocks here.

AMN Healthcare has lost 9.7% compared with the industry’s 39.9% fall in the past year.

ShockWave Medical, sporting a Zacks Rank #1 at present, has an estimated growth rate of 33.1% for 2023. SWAV’s earnings surpassed estimates in all the trailing four quarters, the average beat being 180.1%.

ShockWave Medical has gained 16.3% against the industry’s 37.3% fall over the past year.

McKesson, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 10.1%. MCK’s earnings surpassed estimates in three of the trailing four quarters and missed the same in one, the average beat being 13%.

McKesson has gained 70.8% against the industry’s 19.2% fall over the past year.

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