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Thermo Fisher's (TMO) Autoimmune Disease Test Gets FDA Nod

·4-min read

Thermo Fisher Scientific, Inc. TMO announced the receipt of the FDA clearance for EliA RNA Polymerase III and EliA Rib-P blood tests intended to diagnose systemic sclerosis (SSc) and systemic lupus erythematosus (SLE). With the addition of these tests, the EliA portfolio will deliver a more robust clinical offering through a wide-ranging menu of automated connective tissue disease tests.

The recent development is likely to expand Thermo Fisher’s connective tissue diseases test menu and will enhance the efficiency and productivity of diagnostic laboratories.

More on the News

RNA Polymerase III is a criteria marker for SSc with both diagnostic and prognostic value. Up to 70% of patients who are positive for RNA Polymerase III may have no other SSc-associated antibodies present in them. The EliA RNA Pol III test is the first fully automated RNA Polymerase test available in the United States that completes a criteria-based EliA SSc panel.

Moreover, the EliA Rib-P test is developed with optimal sensitivity and specificity and can be utilized to aid the diagnosis of SLE, particularly in antinuclear antibody negative patients.

Significance of the Tests

It is worth mentioning that the diagnosis of autoimmune diseases can be challenging.  Reliable and accurate laboratory tests that offer clinical clarity are vital tools for clinicians managing these patients. The addition of RNA Polymerase III and Ribosomal P to the EliA connective tissue disease test menu will add substantial value to the diagnosis of SSc and SLE.

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Moreover, the new EliA RNA Pol III and EliA Rib-P tests have been developed to enhance the differentiation of SSc and SLE from other connective tissue diseases. Targeting the existing diagnostic care gaps will help clinicians to make an early and more accurate diagnosis and ultimately improve clinical outcomes for patients.

Industry Prospects

Per a report by MarketsandMarkets, the global autoimmune disease diagnosis market size is expected to grow to $6.3 billion by 2025 from $4.1 billion in 2020, at a CAGR of 8.9%.  An increase in the incidence of autoimmune disease, a surge in adoption of autoimmune disease therapeutics, and growth in R&D activities to develop ideal therapeutics are the factors driving the market.

Recent Developments

In June 2022, Thermo Fisher entered into a co-marketing agreement with TransMIT GmbH Center for Mass Spectrometric Developments to promote the use of a mass spectrometry imaging platform for spatial multi-omics applications in pharma and clinical labs. This collaboration will offer integrated solutions for mass spectrometry imaging, allowing for a label-free approach to mapping the distribution of known and unknown compounds directly sampled from biological tissue.

In May 2022, Thermo Fisher partnered with the Qatar Genome Program, a member of the Qatar Foundation, to expedite genomic research and clinical applications of predictive genomics in Qatar. This collaboration marks a step toward extending the benefits of precision medicine to Arab populations worldwide.

Price Performance

Shares of the company have gained 16% in the past year against the industry’s 21.5% fall.

Zacks Rank and Key Picks

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

A few better-ranked stocks in the broader medical space are UnitedHealth Group Incorporated UNH, Medpace Holdings, Inc. MEDP and Alkermes plc ALKS.

UnitedHealth, having a Zacks Rank #2 (Buy), reported first-quarter 2022 earnings per share (EPS) of $5.49, which beat the Zacks Consensus Estimate by 1.7%. Revenues of $80.1 billion outpaced the consensus mark by 14.2%.

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

UnitedHealth has an estimated long-term growth rate of 14.8%. UNH’s earnings surpassed estimates in the trailing four quarters, the average surprise being 3.7%.

Medpace reported first-quarter 2022 adjusted EPS of $1.69, which surpassed the Zacks Consensus Estimate by 34.1%. Revenues of $330.9 million outpaced the Zacks Consensus Estimate by 1.1%. It currently has a Zacks Rank #2.

Medpace has a historical growth rate of 27.3%. MEDP’s earnings surpassed estimates in the trailing four quarters, the average surprise being 17.1%.

Alkermes reported first-quarter 2022 adjusted EPS of 12 cents, which surpassed the Zacks Consensus Estimate of a penny. Revenues of $278.6 million outpaced the Zacks Consensus Estimate by 6.2%. It currently sports a Zacks Rank #1.

Alkermes has an estimated long-term growth rate of 25.1%. ALKS’ earnings surpassed estimates in the trailing four quarters, the average surprise being 350.5%.

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