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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250602947359/en/
Contacts
Investors: Caroline Cornerinvestors@personalis.com 415-202-5678
Media Contact pr@personalis.com
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
17 minutes ago
- Yahoo
Cadence's (NASDAQ:CDNS) Q2 Sales Top Estimates, Stock Soars
Semiconductor design software provider Cadence Design Systems (NASDAQ:CDNS) reported revenue ahead of Wall Street's expectations in Q2 CY2025, with sales up 20.2% year on year to $1.28 billion. The company's full-year revenue guidance of $5.24 billion at the midpoint came in 0.8% above analysts' estimates. Its non-GAAP profit of $1.65 per share was 5.9% above analysts' consensus estimates. Is now the time to buy Cadence? Find out in our full research report. Cadence (CDNS) Q2 CY2025 Highlights: Revenue: $1.28 billion vs analyst estimates of $1.25 billion (20.2% year-on-year growth, 1.8% beat) Adjusted EPS: $1.65 vs analyst estimates of $1.56 (5.9% beat) The company slightly lifted its revenue guidance for the full year to $5.24 billion at the midpoint from $5.19 billion Management raised its full-year Adjusted EPS guidance to $6.90 at the midpoint, a 1.8% increase Operating Margin: 19%, down from 27.7% in the same quarter last year Free Cash Flow Margin: 26.1%, down from 37.3% in the previous quarter Market Capitalization: $90.7 billion 'Cadence delivered an exceptional Q2, with 20% year-over-year revenue growth and stronger than expected bookings. This highlighted the strategic relevance of our AI-driven portfolio and the depth of our customer relationships,' said Anirudh Devgan, president and chief executive officer. Company Overview With the name chosen to reflect the idea of a repeating pattern or rhythm in electronic design, Cadence Design Systems (NASDAQ:CDNS) offers a software-as-a-service platform for semiconductor engineering and design. Revenue Growth Examining a company's long-term performance can provide clues about its quality. Any business can put up a good quarter or two, but the best consistently grow over the long haul. Over the last three years, Cadence grew its sales at a 15.7% compounded annual growth rate. Although this growth is acceptable on an absolute basis, it fell slightly short of our standards for the software sector, which enjoys a number of secular tailwinds. Luckily, there are other things to like about Cadence. This quarter, Cadence reported robust year-on-year revenue growth of 20.2%, and its $1.28 billion of revenue topped Wall Street estimates by 1.8%. Looking ahead, sell-side analysts expect revenue to grow 7.9% over the next 12 months, a deceleration versus the last three years. This projection doesn't excite us and indicates its products and services will face some demand challenges. At least the company is tracking well in other measures of financial health. Software is eating the world and there is virtually no industry left that has been untouched by it. That drives increasing demand for tools helping software developers do their jobs, whether it be monitoring critical cloud infrastructure, integrating audio and video functionality, or ensuring smooth content streaming. Click here to access a free report on our 3 favorite stocks to play this generational megatrend. Customer Acquisition Efficiency The customer acquisition cost (CAC) payback period represents the months required to recover the cost of acquiring a new customer. Essentially, it's the break-even point for sales and marketing investments. A shorter CAC payback period is ideal, as it implies better returns on investment and business scalability. Cadence is extremely efficient at acquiring new customers, and its CAC payback period checked in at 6.1 months this quarter. The company's rapid recovery of its customer acquisition costs means it can attempt to spur growth by increasing its sales and marketing investments. Key Takeaways from Cadence's Q2 Results This was a classic 'beat and raise' quarter. Specifically, it was great to see Cadence beat on revenue and EPS. It was also a major positive that the company slightly raised i's full-year revenue and EPS guidance above analysts' expectations. Overall, we think this was a solid quarter with some key areas of upside. The stock traded up 7.7% to $359.48 immediately following the results. Cadence had an encouraging quarter, but one earnings result doesn't necessarily make the stock a buy. Let's see if this is a good investment. What happened in the latest quarter matters, but not as much as longer-term business quality and valuation, when deciding whether to invest in this stock. We cover that in our actionable full research report which you can read here, it's free. 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
Yahoo
17 minutes ago
- Yahoo
Cellectis to Report Second Quarter 2025 Financial Results on August 4, 2025
NEW YORK, July 28, 2025 (GLOBE NEWSWIRE) -- Cellectis (the 'Company') (Euronext Growth: ALCLS- NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, today announced that it will report financial results for the second quarter 2025 ending June 30, 2025 on Monday August 4, 2025 after the close of the US market. The publication will be followed by an investor conference call and webcast on Tuesday August 5, 2025 at 8:00 AM ET / 2:00 PM CET. The call will include the Company's second quarter results and an update on business activities. Details for the call are as follows: Dial in information: Domestic: +1-800-343-5172 International: +1-203-518-9856 Conference ID: CLLSQ2 Webcast Link: About Cellectis Cellectis is a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies. The company utilizes an allogeneic approach for CAR T immunotherapies in oncology, pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients, and a platform to develop gene therapies in other therapeutic indications. With its in-house manufacturing capabilities, Cellectis is one of the few end-to-end gene editing companies that controls the cell and gene therapy value chain from start to finish. Cellectis' headquarters are in Paris, France, with locations in New York and Raleigh, NC. Cellectis is listed on the Nasdaq Global Market (ticker: CLLS) and on Euronext Growth (ticker: ALCLS). To find out more, visit and follow Cellectis on LinkedIn and X. TALEN® is a registered trademark owned by Cellectis. For further information on Cellectis, please contact: Media contacts: Pascalyne Wilson, Director, Communications, + 33 (0)7 76 99 14 33, media@ Patricia Sosa Navarro, Chief of Staff to the CEO, +33 (0)7 76 77 46 93 Investor Relations contact: Arthur Stril, Chief Financial Officer & Chief Business Officer, investors@ Attachment 20250728_Q2 2025 earnings call announcement_ENGLISHError while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Los Angeles Times
18 minutes ago
- Los Angeles Times
Wall Street kicks off a week full of potential flashpoints with a whisper
Stock indexes drifted through a quiet Monday after the United States agreed to tax cars and other products coming from the European Union at a 15% rate, lower than President Donald Trump had earlier threatened. Many details of the trade deal are still to be worked out, and Wall Street is heading into a week full of potential flashpoints that could shake markets. The S&P 500 was nearly flat and edged up by less than 0.1% to set an all-time high for a sixth straight day. The Dow Jones Industrial Average dipped 64 points, or 0.1%, while the Nasdaq composite added 0.3% to its own record. Tesla rose 3% after its CEO, Elon Musk, said it signed a deal with Samsung Electronics that could be worth more than $16.5 billion to provide chips for the electric-vehicle company. Samsung's stock in South Korea jumped 6.8%. Other companies in the chip and artificial-intelligence industries were strong, continuing their run from last week after Alphabet said it was increasing its spending on AI chips and other investments to $85 billion this year. Chip company Advanced Micro Devices rose 4.3%, and server-maker Super Micro Computer climbed 10.2%. But an 8.3% drop for Revvity helped to keep the market in check. The company in the life sciences and diagnostics businesses reported a stronger profit for the latest quarter than Wall Street expected, but its forecast for full year profit disappointed analysts. Companies are broadly under pressure to deliver solid growth in profits following big jumps in their stock prices the last few months. Much of the gain was due to hopes that Trump would walk back some of his stiff proposed tariffs, and critics say the U.S. stock market looks expensive unless companies produce bigger profits. All told, the S&P 500 added 1.13 to 6,389.77 points. The Dow Jones Industrial Average dipped 64.36 to 44,837.56, and the Nasdaq composite rose 70.27 to 21,178.58. More fireworks may be ahead this week. 'This is about as busy as a week can get in the markets,' according to Chris Larkin, managing director, trading and investing, at E-Trade from Morgan Stanley. Hundreds of U.S. companies are lined up to report how much profit they made during the spring, with nearly a third of the businesses in the S&P 500 index scheduled to deliver updates. That includes market heavyweights Apple, Amazon, Meta Platforms and Microsoft. Those companies have grown so huge that their stock movements can almost dictate what the overall S&P 500 index does. Microsoft alone is worth $3.8 trillion. On Wednesday, the Federal Reserve will announce its latest decision on interest rates. Trump has been angrily calling for the Fed to cut interest rates, a move that could give the economy a boost. But Fed Chair Jerome Powell insists that he wants more data about how Trump's tariffs are affecting the economy and inflation before the Fed makes its next move. Lower interest rates can fuel inflation, and the economy only recently came out of its scarring run where inflation briefly topped 9%. The widespread expectation on Wall Street is that Fed officials will wait until September to resume cutting interest rates, though a couple of Trump's appointees could dissent in the vote. The Fed has been on hold with interest rates this year since cutting them several times at the end of 2024. This week will also feature several potentially market-moving updates about the economy. On Tuesday will come reports on how confident U.S. consumers are feeling and how many jobs openings U.S. employers were advertising. Wednesday will show the first estimate of how quickly the U.S. economy grew during the spring, and economists expect to see a slowdown from the first three months of the year. On Thursday, the latest measure of inflation that the Federal Reserve prefers to use will arrive. A modest reading could give the Fed more leeway to cut interest rates in the short term, while a hotter-than-expected figure could make it more cautious. And Friday will bring an update on how many more workers U.S. employers hired during June than they fired. Treasury yields held relatively steady in the bond market ahead of all that action. The yield on the 10-year Treasury edged up to 4.41% from 4.40% late Friday. The two-year Treasury yield, which more closely tracks expectations for Fed action, rose to 3.92% from 3.91%. In stock markets abroad, indexes dipped in Europe following the announcement of the trade deal's framework. Chinese stocks rose as officials from the world's second-largest economy prepared to meet with a U.S. delegation in Sweden for trade talks. Stocks climbed 0.7% in Hong Kong and 0.1% in Shanghai. Indexes were mixed across the rest of Asia, where Japan's Nikkei 225 fell 1.1% for one of the world's bigger losses. Choe writes for the Associated Press.
