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TEM Continues to Strengthen Its Genomics Leadership With New Products
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Key Takeaways
TEM gained FDA clearance for its xR IVD and launched xM for treatment response monitoring.
Tempus AI is developing a CDx with Verastem, tied to RAMP-201 and used in the RAMP-301 trial.
TEM plans to debut its Xh whole-genome test as MRD reimbursement and xF regulatory filing progress.
Tempus AI (TEM - Free Report) has been putting in efforts to solidify its position in the genomics space. In September 2025, the company received FDA 510(k) clearance for its xR IVD to support life sciences drug development programs. The xR IVD assay is a qualitative next generation sequencing-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for detection of rearrangements in two genes, using RNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens from patients with solid malignant neoplasms.
It also launched xM for Treatment Response Monitoring (“TRM”), a new liquid biopsy assay designed to track tumor fraction changes in patients undergoing immune-checkpoint inhibitor (ICI) therapy.
Additionally, Tempus is developing a companion diagnostic (CDx) test with Verastem Oncology (VSTM - Free Report) , having completed confirmatory testing in VSTM’s Phase 2 RAMP-201 clinical trial. The study evaluated the combination of avutometinib and defactinib to treat recurrent low-grade serous ovarian cancer (LGSOC). And now, Tempus’ FDA-approved xT CDx assay is being leveraged as an investigational assay in Verastem’s global Phase 3 RAMP-301 clinical trial.
Looking ahead, the company plans to introduce its first whole-genome sequencing (WGS) test, Xh, next year to detect clinically relevant variants, particularly in hematologic oncology. With MRD reimbursement progressing and regulatory filing for the xF liquid biopsy expected later this year, additional growth tailwinds are anticipated.
Peer Update
In September 2025, Exact Sciences (EXAS - Free Report) launched its Cancerguard multi-cancer early detection (MCED) test as a laboratory-developed test. EXAS is also benefiting from strong global uptake of its Oncotype DX genomic test. Additionally, Exact Sciences launched the Oncodetect molecular residual disease (MRD) test as a laboratory-developed test (LDT), which enhances understanding of cancer recurrence and helps support timely, personalized treatment decisions.
Guardant Health (GH - Free Report) recently expanded Shield to include multi-cancer detection (MCD) and initiated a large-scale real-world data initiative for Shield MCD. GH received new Guardant360 companion diagnostic approvals for breast cancer and non-small cell lung cancer. In May, the company rolled out its Guardant Hereditary Cancer test to detect genetic variants linked to cancer risk. Guardant Health also unveiled an enhanced molecular profiling assay that uses approximately 40% fewer tissue slides than standard tests, allowing more patients to be evaluated when tissue samples are limited. The company
TEM Stock Outperforms Industry & Benchmark
In the past year, Tempus AI shares have rallied 20%, outperforming the industry’s 11.1% growth and the S&P 500 composite’s 17.5% improvement.
Image Source: Zacks Investment Research
Expensive Valuation
TEM currently trades at a forward 12-month Price-to-Sales (P/S) of 8.13X compared with the industry average of 5.81X.
Image Source: Zacks Investment Research
TEM Stock Estimate Trend
In the past 60 days, Tempus AI's loss per share estimate for 2025 has improved 3 cents.
Image: Bigstock
TEM Continues to Strengthen Its Genomics Leadership With New Products
Key Takeaways
Tempus AI (TEM - Free Report) has been putting in efforts to solidify its position in the genomics space. In September 2025, the company received FDA 510(k) clearance for its xR IVD to support life sciences drug development programs. The xR IVD assay is a qualitative next generation sequencing-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for detection of rearrangements in two genes, using RNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens from patients with solid malignant neoplasms.
It also launched xM for Treatment Response Monitoring (“TRM”), a new liquid biopsy assay designed to track tumor fraction changes in patients undergoing immune-checkpoint inhibitor (ICI) therapy.
Additionally, Tempus is developing a companion diagnostic (CDx) test with Verastem Oncology (VSTM - Free Report) , having completed confirmatory testing in VSTM’s Phase 2 RAMP-201 clinical trial. The study evaluated the combination of avutometinib and defactinib to treat recurrent low-grade serous ovarian cancer (LGSOC). And now, Tempus’ FDA-approved xT CDx assay is being leveraged as an investigational assay in Verastem’s global Phase 3 RAMP-301 clinical trial.
Looking ahead, the company plans to introduce its first whole-genome sequencing (WGS) test, Xh, next year to detect clinically relevant variants, particularly in hematologic oncology. With MRD reimbursement progressing and regulatory filing for the xF liquid biopsy expected later this year, additional growth tailwinds are anticipated.
Peer Update
In September 2025, Exact Sciences (EXAS - Free Report) launched its Cancerguard multi-cancer early detection (MCED) test as a laboratory-developed test. EXAS is also benefiting from strong global uptake of its Oncotype DX genomic test. Additionally, Exact Sciences launched the Oncodetect molecular residual disease (MRD) test as a laboratory-developed test (LDT), which enhances understanding of cancer recurrence and helps support timely, personalized treatment decisions.
Guardant Health (GH - Free Report) recently expanded Shield to include multi-cancer detection (MCD) and initiated a large-scale real-world data initiative for Shield MCD. GH received new Guardant360 companion diagnostic approvals for breast cancer and non-small cell lung cancer. In May, the company rolled out its Guardant Hereditary Cancer test to detect genetic variants linked to cancer risk. Guardant Health also unveiled an enhanced molecular profiling assay that uses approximately 40% fewer tissue slides than standard tests, allowing more patients to be evaluated when tissue samples are limited. The company
TEM Stock Outperforms Industry & Benchmark
In the past year, Tempus AI shares have rallied 20%, outperforming the industry’s 11.1% growth and the S&P 500 composite’s 17.5% improvement.
Image Source: Zacks Investment Research
Expensive Valuation
TEM currently trades at a forward 12-month Price-to-Sales (P/S) of 8.13X compared with the industry average of 5.81X.
Image Source: Zacks Investment Research
TEM Stock Estimate Trend
In the past 60 days, Tempus AI's loss per share estimate for 2025 has improved 3 cents.
Image Source: Zacks Investment Research
TEM stock currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.