Tempus receives FDA clearance for RNA-based diagnostic device

CHICAGO - Tempus AI, Inc. (NASDAQ:TEM), a precision medicine company with a market capitalization of $15.3 billion and impressive 71.8% growth over the past six months according to InvestingPro, announced Monday it has received 510(k) clearance from the U.S. Food and Drug Administration for its RNA-based Tempus xR IVD device, which will be offered as a life sciences tool to support drug development programs.

The Tempus xR IVD assay is a qualitative next generation sequencing-based diagnostic device that uses targeted technology to detect rearrangements in two genes from tumor tissue specimens. The device is intended for use by qualified healthcare professionals in accordance with oncology guidelines for patients with previously diagnosed solid malignant neoplasms.

"We have long known that RNA sequencing offers additional insights beyond DNA alone, but only now are we beginning to unlock its full value in supporting therapeutic development," said Kate Sasser, Chief Scientific Officer at Tempus. The company’s focus on innovation is reflected in its strong revenue growth of 59.8% over the last twelve months, as reported by InvestingPro.

The company stated that RNA sequencing captures biological information that can provide deeper insights into disease mechanisms, including enhanced fusion detection. According to Tempus, RNA analysis is becoming an increasingly important tool in research and development because it can identify molecular pathways directly involved in disease progression.

Tempus noted that the FDA authorization strengthens its position as a provider of precision medicine solutions. The company offers a collection of diagnostic tools and a multimodal dataset that supports therapeutic innovation. While trading near its 52-week high of $91.45, InvestingPro analysis indicates the stock may be overvalued, with 12 additional exclusive ProTips available for subscribers looking to make informed investment decisions in this rapidly growing healthcare technology sector.

The information provided by xR IVD is not intended to be prescriptive or conclusive for labeled use of any specific therapeutic product, according to the company’s statement based on a press release.

In other recent news, Tempus AI announced it received 510(k) clearance from the U.S. Food and Drug Administration for its updated Tempus Pixel cardiac imaging platform. This regulatory approval enhances the platform’s capabilities, allowing for advanced cardiac MR image analysis, which could aid clinicians in detecting conditions such as fibrosis and inflammation. Following this announcement, H.C. Wainwright raised its price target for Tempus AI to $98.00, maintaining a Buy rating. Additionally, Stifel reiterated its Hold rating with a $65.00 price target, citing ongoing discussions with Tempus AI’s management about business trends and the ramp-up of reimbursement for its xT genomic profiling test.

Tempus AI has also filed a prospectus supplement with the U.S. Securities and Exchange Commission for the potential resale of up to 1.27 million shares of its Class A common stock by certain stockholders. This filing is part of an automatic shelf registration statement originally filed in August. Furthermore, H.C. Wainwright initiated coverage of Tempus AI with a Buy rating and a $90.00 price target, noting the company’s significant role in advancing precision medicine through AI applications. These developments reflect the company’s ongoing efforts to expand its market presence and technological capabilities in the healthcare sector.

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