
New Data Shows NeXT Personal ® Identifies Breast Cancer Patients Receiving Neoadjuvant Therapy that are at High Risk for Relapse
'Many triple negative breast cancer patients receive neoadjuvant therapy prior to surgery as standard of care. The data from these two studies independently suggest that an ultrasensitive ctDNA assay like NeXT Personal could help these patients better understand their risk of relapse, with the potential to help inform the need for additional therapy,' said Richard Chen, MD, Chief Medical Officer and Executive Vice President, R&D at Personalis. 'We believe this data, once published, can form the basis for seeking reimbursement coverage for neoadjuvant therapy monitoring in breast cancer. We are excited to continue to work with leading collaborators to expand the data around the use of NeXT Personal in breast cancer with the goal of helping breast cancer patients optimize their care.'
Results from the PREDICT DNA study were presented yesterday by Dr. Natasha Hunter, MD, University of Washington, at the American Society for Clinical Oncology (ASCO) 2025 Annual Meeting in Chicago in an oral presentation titled 'Circulating tumor DNA, pathologic response after neoadjuvant therapy, and survival: First results from TBCRC 040 (the PREDICT DNA trial).'
'The PREDICT DNA study prospectively evaluated ctDNA in early-stage patients with HER2-positive and triple negative breast cancer. The trial was initiated a decade ago and accrued 228 patients across 22 sites in the United States, and was statistically designed and powered for analysis of ctDNA to predict for pathologic complete response (pCR), and whether ctDNA could be a prognostic test to identify patients at high vs. very low risk for recurrence,' said Dr. Ben Park, MD PhD, Vanderbilt-Ingram Cancer Center. 'We partnered with Personalis because of their technology's ultrasensitive detection of ctDNA down to 1 to 3 parts per million. Our results demonstrate that patients who 'clear' their ctDNA after upfront chemotherapy have excellent outcomes that mirror those with pCR, identifying a group of patients who, despite having residual disease at the time of surgery, will be at extremely low risk for recurrence. Conversely, those with detectable ctDNA after upfront chemotherapy are at a much higher risk of recurrence, and serial ctDNA measurements after surgery can help identify patients who may benefit from either escalation or de-escalation of therapies. We are truly excited by these results as they will allow us to more precisely risk-stratify patients with breast cancer in future trials and clinical practice.'
Key findings included:
ctDNA status after completion of NAT (post-NAT) was highly prognostic for relapse-free survival (RFS).
Patients with ctDNA detected post-NAT were ~10 times more likely to relapse than patients who were ctDNA negative.
Detection of ctDNA post-NAT was more predictive of recurrence than pCR.
Patients who did not have detectable post-NAT ctDNA had excellent outcomes regardless of pathologic response.
Preliminary analyses indicate that patients who had post-surgical ctDNA detected were >85 times more likely to experience disease recurrence.
48% of post-NAT ctDNA detections were <100 PPM, highlighting the importance of NeXT Personal's ultrasensitive performance.
Overall, the results suggest that ultrasensitive ctDNA detection in patients with TNBC after completion of NAT and prior to surgery may be used as a prognostic marker, independent of pCR, to guide clinical decision making for additional adjuvant therapies.
Dr. Luc Cabel, MD, PhD, Institut Curie, Paris, presented results from a second study titled 'Ultrasensitive circulating tumor DNA (ctDNA) detection for prognostication in triple-negative breast cancer (TNBC) post-neoadjuvant chemotherapy (NAC).' This study included 86 patients with early stage (Stage I-III) TNBC receiving neoadjuvant therapy. Key findings included:
ctDNA was detected in 100% (84/84) of pretreatment baseline plasma samples.
The majority of ctDNA detections during NAT (51%) and post-NAT (55%) were in the ultrasensitive range below 100 PPM of ctDNA.
Post-NAT ctDNA status was highly prognostic. Patients with ctDNA detected post-NAT were ~36 times more likely to have a distant relapse than patients who tested negative.
For patients who were non-pCR, ctDNA negative patients were 93% less likely to relapse than ctDNA positive patients.
ctDNA status can be combined with pCR status to assess patient distant relapse risk following NAT.
Said François-Clément Bidard, MD, PhD, one of the Institut Curie lead investigators on the study, 'Our results uncover the clinical need for ultrasensitive MRD testing, and pave the way for ctDNA-based adjuvant therapy decisions in early triple negative breast cancer.'
About Personalis, Inc.
At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care throughout the patient journey. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit www.personalis.com and connect with us on LinkedIn and X (Twitter).
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release that are not historical are 'forward-looking statements' within the meaning of U.S. securities laws, including statements relating to the attributes, advantages, sensitivity, clinical relevance or importance of the NeXT Personal test. Such forward-looking statements involve known and unknown risks and uncertainties and other factors that may cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements, including the risks, uncertainties and other factors that relate to the ability of NeXT Personal to detect small traces of ctDNA, detect residual or recurrent cancer early (including detection earlier than standard of care imaging), monitor or predict a patient's response to therapy or risk of cancer recurrence, accurately predict clinical outcomes for cancer patients, or impact cancer care or management (including for escalation or de-escalation of treatment), or to the clinical adoption or use of, or the ability of Personalis to obtain Medicare coverage or reimbursement for, the NeXT Personal test, or to the sufficiency of the publication and study results described in this press release to support such adoption, use, coverage or reimbursement. These and other potential risks and uncertainties that could cause actual results to differ materially from the results predicted in these forward-looking statements are described under the captions 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' in Personalis' Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission (SEC) on February 27, 2025, and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 6, 2025. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law.
Not affiliated with or endorsed by ASCO.
Hashtags

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
10 hours ago
- Yahoo
Where Will Intuitive Surgical Be in 5 Years?
Key Points Sector rotation and a hot valuation are weighing on shares of Intuitive Surgical. The company still has a healthy growth runway ahead with its core da Vinci system. However, it's important to avoid overpaying for even the best of companies. 10 stocks we like better than Intuitive Surgical › Intuitive Surgical (NASDAQ: ISRG) is one of the best success stories you'll find in the healthcare sector. The company has helped patients worldwide as a pioneer in robotic-assisted surgery, and its business success has driven the stock to returns of over 25,000% since its initial public offering (IPO) in 2000. The company's flagship da Vinci system remains its crown jewel today and continues to drive profitable growth from an increasingly larger installed base. Yet the stock has wavered recently, currently sitting in the middle of its 52-week range. Is this a dip worth buying for the next five years, or is Intuitive Surgical losing its edge? Here is where the stock may go over the coming years. A hefty valuation could be weighing on the share price Intuitive Surgical currently trades at a price-to-earnings (P/E) ratio of 75. Meanwhile, analysts estimate the company will grow earnings by an average of just over 13.8% annually over the long term. The company has a sterling reputation for its long track record of business and investment performance; however, it's challenging to justify such a high valuation for the growth Wall Street anticipates. At the same time, the broader S&P 500 healthcare sector is trading near the low end of its 52-week range, which suggests that healthcare stocks aren't particularly popular at the moment. Although the broader stock market is near all-time highs, individual stocks, entire industries, or market sectors may be hot or cold at any given time. Sometimes, the simple explanation is the correct one. Market sentiment is working against the healthcare sector, so Intuitive Surgical's expensive valuation appears to be weighing on the stock. It happens. Intuitive Surgical still has more growth ahead That said, market dynamics can and will change over time, and five years is a considerable amount of time. Top-line and bottom-line growth tend to drive a stock's long-term performance, so it's essential to understand where a company stands in its business journey. Intuitive Surgical currently sells two systems: its da Vinci system, available in single- and multi-port configurations, used for a variety of soft tissue procedures, and the Ion, the company's newer system, used for performing minimally invasive peripheral lung biopsies. As of June 30, there are 10,488 da Vinci systems installed worldwide, generating recurring revenue for Intuitive Surgical as these systems consume supplies and require servicing over time. The global da Vinci installed base performed 17% more procedures in Q2 than the prior year, indicating that growth remains relatively healthy (no pun intended). The company estimates its core (da Vinci) addressable market at approximately 8 million annual soft tissue procedures, based on the da Vinci systems' current regulatory approvals and capabilities. Considering da Vinci systems will perform over 3 million procedures this year, it seems that Intuitive Surgical still has room for solid short- and medium-term growth, and that's speaking to organic growth, as in more installed systems and procedures. As a bonus, Intuitive Surgical has zero debt, is highly profitable, and has $4.5 billion in cash. Management could lean more into share repurchases to help grow its earnings per share. Given all of this, the 13% annualized growth rate Wall Street anticipates seems achievable. Where might the stock price be in five years? Investors can extrapolate this growth rate to see where the stock may trade over time. Applying that 13.8% growth rate to Intuitive Surgical's trailing-12-month earnings per share of $6.82, the company's earnings would grow something like this: 2026: $7.76 2027: $8.83 2028: $10.05 2029: $11.44 2030: $13.02 The stock has averaged a P/E ratio of 62 over the past 10 years, so here is where the stock may trade in five years, based on its current valuation and some other scenarios: Price-to-Earnings Ratio July 2030 Share Price Total Upside or Downside 75 $976 91% 65 $846 66% 55 $716 40% 45 $586 15% 35 $456 (11%) Calculations by author. If Intuitive Surgical reverts closer to its long-term averages, the current valuation could easily continue to weigh on the stock. Therefore, investors may want to err on the side of caution and focus on the lower valuations. If the broader market stumbles, Intuitive Surgical could even drop to a P/E ratio below its long-term norms. It's always good to build a margin of safety into these exercises. Intuitive Surgical hasn't lost its edge, but it is an overvalued stock. Investors may want to prepare for a five-year period in which the stock delivers underwhelming returns, in case Intuitive Surgical's valuation returns to a more appropriate level for its expected growth. Should you invest $1,000 in Intuitive Surgical right now? Before you buy stock in Intuitive Surgical, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Intuitive Surgical wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $636,774!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $1,064,942!* Now, it's worth noting Stock Advisor's total average return is 1,040% — a market-crushing outperformance compared to 182% for the S&P 500. Don't miss out on the latest top 10 list, available when you join Stock Advisor. See the 10 stocks » *Stock Advisor returns as of July 21, 2025 Justin Pope has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Intuitive Surgical. The Motley Fool has a disclosure policy. Where Will Intuitive Surgical Be in 5 Years? was originally published by The Motley Fool
Yahoo
a day ago
- Yahoo
Wells Fargo Raises PT on Health Catalyst, Inc. (HCAT); Maintains ‘Buy' Rating
Health Catalyst, Inc. (NASDAQ:HCAT), having a share price under $10, strong hedge fund interest, and a low price-to-earnings ratio, ranks among the . A data center operator working on a rack of servers, emphasizing the company's cloud services. On July 1, 2025, Wells Fargo set its price target at $10 for Health Catalyst, Inc. (NASDAQ:HCAT), maintaining a 'Buy' rating. HCAT's shares are currently trading at around $4, implying a significant upside as per the analyst. The analyst believes that Health Catalyst, Inc. (NASDAQ:HCAT) is valued much lower than its peers, which sets the company up for future growth through consistent performance. The firm expects positive growth in the company's bookings in the upcoming Q2, which is likely to boost investor sentiment. Meanwhile, the company's strong revenue visibility for 2025 is noted, along with an anticipated acceleration in its DOS client growth. Looking ahead, the analyst expects the company to improve its dollar-based retention rate, enhancing its customer loyalty and revenue base. Legislative uncertainties, on the other hand, are expected to be short-term concerns with minimal long-term impact. Lastly, the company's EBITDA growth was also highlighted as a key reason for the optimistic outlook. With Health Catalyst Ignite, a cloud-based data and analytics platform, Health Catalyst, Inc. (NASDAQ:HCAT) serves healthcare entities, enhancing clinical, financial, and operational results. It is included in our list of the best cloud stocks. While we acknowledge the potential of HCAT as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 14 Cheap Transportation Stocks to Buy According to Analysts and 11 Best Mineral Stocks to Buy According to Hedge Funds. Disclosure: None.
Yahoo
2 days ago
- Yahoo
Assembly Bio's (ASMB) HBV Drug Shows Strong Efficacy in Phase 1b Trial
Assembly Biosciences, Inc. (NASDAQ:ASMB) is one of the growth stocks that could double by 2027. On June 25, the company announced positive topline results from its Phase 1b trial of ABI-4334, a capsid assembly modulator for the treatment of chronic hepatitis B. A scientist in a white lab coat working at a bench with biopharmaceutical equipment. The 28-day study showed HBV DNA reductions of 2.9 log10 IU/mL at 150 mg and 3.2 log10 IU/mL at 400 mg, with additional declines in HBV RNA. The lower dose achieved saturated inhibition of viral replication, while the higher dose may enhance suppression of cccDNA formation, a key viral reservoir. The drug was well-tolerated, with no serious adverse events and pharmacokinetics supporting once-daily oral dosing. These results activate a licensing decision for Gilead Sciences, which holds rights to further develop ABI-4334. Assembly Biosciences, Inc. (NASDAQ:ASMB) is a clinical-stage biotech focused on small-molecule therapies for serious viral infections. Its pipeline includes candidates for hepatitis B, hepatitis delta, herpesviruses, and transplant-related infections. The company collaborates with Gilead Sciences to advance next-generation antiviral treatments. While we acknowledge the potential of ASMB as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data