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Thermo Fisher (TMO) Gets FDA Clearance for Its Immunoassays

Thermo Fisher Scientific TMO recently declared the FDA clearance of its novel biomarker tests — B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR. These are the first and only immunoassays to receive breakthrough designation and clearance for the risk assessment and clinical management of preeclampsia, a severe pregnancy complication.

The recent development is likely to have a significant impact on the prognosis and treatment of thousands of women at risk for preeclampsia every year in the United States.

Significance of the Biomarker Tests

Preeclampsia is known to be the leading cause of maternal and fetal mortality and morbidity worldwide. Over the last decade, the incident rates of this life-threatening blood pressure disorder have increased rapidly in the United States.

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B·R·A·H·M·S sFlt-1 KRYPTOR and B·R·A·H·M·S PlGF plus KRYPTOR assays are designed to be used along with other laboratory tests and clinical assessments to determine the risks of pregnant women who have been hospitalized for hypertensive disorders of pregnancy. The assays run on the Thermo Scientific B·R·A·H·M·S KRYPTOR compact PLUS clinical chemistry analyzer.

The PRAECIS (Preeclampsia Risk Assessment: Evaluation of Cut-offs to Improve Stratification) study validates that novel biomarkers aid in detecting the development of severe preeclampsia. Based on the risk stratification ratio of the two assays, women who tested positive will receive enhanced surveillance and accelerated care before severe features develop.

Thermo Fisher is focused on advancing diagnostic solutions for reproductive health as part of the broader mission to enable its customers to make a healthier and safer world. Following the FDA clearance, the availability of these novel biomarker tests will allow caregivers across the United States to better manage and potentially improve outcomes for both mothers and their newborns.

Industry Prospects

Per a Research report, the global preeclampsia diagnostics market size was valued at $1.03 billion in 2021 and is expected to witness a CAGR of 2.2% up to 2029.

Recent Developments

In May 2023, Thermo Fisher collaborated with Pfizer to expand next-generation sequencing-based testing capabilities in more than 30 countries across Latin America, Africa, the Middle East and Asia, where access to affordable advanced genomic testing has been previously limited or unavailable.

In March 2023, Thermo Fisher announced a strategic collaboration with Arsenal Biosciences, Inc. The aim is to enable the latter to develop a robust manufacturing process for next-generation, programmable autologous T cells for the treatment of cancer.

Price Performance

In the past six months, Thermo Fisher has mostly underperformed its industry. TMO shares have decreased 3.2% compared to the industry’s rise of 5.2%.

Zacks Rank and Key Picks

Thermo Fisher currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the overall healthcare sector are Penumbra PEN, Lantheus LNTH and Neuronetics STIM. While Penumbra and Lantheus each sport a Zacks Rank #1 (Strong Buy), Neuronetics carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Penumbra’s stock has risen 122.9% in the past year. The Zacks Consensus Estimate for Penumbra’s earnings per share (EPS) has increased from $1.47 to $1.56 for 2023 and from $2.51 to $2.56 for 2024 in the past seven days.

PEN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 109.42%. In the last reported quarter, the company registered an earnings surprise of 109.09%.

The Zacks Consensus Estimate for Lantheus’ 2023 EPS has increased from $4.95 to $5.60 in the past 30 days. Shares of the company have improved 46.4% in the past year against the industry’s 29.6% decline.

LNTH’s earnings beat estimates in each of the trailing four quarters, the average surprise being 25.77%. In the last reported quarter, the company recorded an earnings surprise of 13.95%.

Estimates for Neuronetics’ loss per share have narrowed from $1.32 to $1.29 for 2023 in the past seven days. Shares of the company have risen 9.7% in the past year compared with the industry’s 2.3% growth.

STIM’s earnings beat estimates in each of the trailing four quarters, the average surprise being 19.61%. In the last reported quarter, Neuronetics delivered an earnings surprise of 2.56%.

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Thermo Fisher Scientific Inc. (TMO) : Free Stock Analysis Report

Penumbra, Inc. (PEN) : Free Stock Analysis Report

Lantheus Holdings, Inc. (LNTH) : Free Stock Analysis Report

Neuronetics, Inc. (STIM) : Free Stock Analysis Report

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