Thermo Fisher's (TMO) EXTENT Solution Makes Commercial Launch

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Thermo Fisher Scientific TMO recently announced the commercial launch of the EXENT Solution. The latest development came on the heels of receiving the IVDR (EU Quality Management System Certificate) certification. The EXENT Solution is intended to aid the diagnosis of monoclonal gammopathies and the monitoring of multiple myeloma and Waldenström’s macroglobulinemia patients.

The automated mass spectrometry system is an innovative breakthrough for the detection and monitoring of monoclonal immunoglobulins. Presently, the solution is commercially available in Belgium, France, Germany, Italy, the Netherlands, Spain and the United Kingdom.

About EXTENT Solution

The EXENT Solution was developed with the Mayo Clinic intellectual property, combining industry leadership in innovation with Mayo’s expertise in monoclonal gammopathy research. The solution enables clinical laboratories to measure, quantify and track specific endogenous M-proteins and exogenous therapeutic monoclonal antibodies with enhanced analytical sensitivity and specificity in serum.

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It features three integrated modules — EXENT-iP500, an automated sample preparation instrument; EXENT-iX500, a Matrix-Assisted Laser Desorption Ionization - Time of Flight Mass Spectrometer (MALDI-ToF MS) and EXENT-iQ, the intelligent and intuitive workflow software that includes data review. The analyzer is combined with the EXENT Immunoglobulin Isotypes immunoassay — a highly sensitive and specific immunoassay for measuring and quantifying IgG, IgA and IgM.

News in Detail

The treatment for monoclonal gammopathies is often determined by monitoring M-protein levels, which can indicate the tumor size.  However, many patients are achieving M-protein concentrations below detectable limits using standard techniques due to remarkable treatment successes in recent years. However, differences in disease progression still exist within this group.

The EXENT Solution addresses this unmet clinical need for more sensitive analytical methods that can differentiate between subsets without initiating invasive bone marrow biopsy techniques too early. The solution is also supported by intelligent software with automated algorithm data processing that minimizes manual labor, enhances data accuracy and expedites analysis.

Industry Prospects

Per a Research report, the global monoclonal antibody market was valued at $210.06 billion in 2022 and is expected to witness a CAGR of 11.04% in the 2023-2030 period.

Recent Developments

Earlier this week, Thermo Fisher announced the launch of CytoScan HD Accel — a new chromosomal microarray designed to improve cytogenetic research lab productivity, efficiency and profitability with an industry-leading two-day turnaround time.

In addition, the company completed the acquisition of CorEvitas, which was announced in July 2023. CorEvitas’ highly complementary real-world evidence solutions will expand TMO’s clinical research business and help enhance decision-making as well as the time and cost of drug development.

Price Performance

In the past six months, TMO shares have decreased 0.6% compared with the industry’s fall of 2.8%.

Zacks Rank and Key Picks

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

Some better-ranked stocks in the broader medical space are Haemonetics HAE, Quanterix QTRX and SiBone SIBN. While Haemonetics sports a Zacks Rank #1 (Strong Buy), Quanterix and SiBone each carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Haemonetics’stock has risen 15% in the past year. Earnings estimates for Haemonetics have increased from $3.56 to $3.74 in 2023 and $3.96 to $4.07 in 2024 in the past 30 days.

HAE’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.39%. In the last reported quarter, it posted an earnings surprise of 38.16%.

Estimates for Quanterix’s 2023 loss per share have narrowed from $1.19 to 97 cents in the past 30 days. Shares of the company have increased 159.5% in the past year against the industry’s decline of 1.4%.

QTRX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 30.39%. In the last reported quarter, it posted an earnings surprise of 55.56%.

Estimates for SiBone’s2023 loss have narrowed from $1.42 to $1.27 per share in the past 30 days. Shares of the company have increased 23.6% in the past year against the industry’s fall of 0.5%.

SIBN’s earnings beat estimates in all the trailing four quarters, the average surprise being 20.37%. In the last reported quarter, SiBone delivered an earnings surprise of 26.83%.

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