Personalis, Inc. reports recurring developments in advanced genomics for precision oncology, with emphasis on personalized cancer testing, minimal residual disease monitoring and sequencing-based data analysis services. Company updates frequently center on the NeXT Personal ultrasensitive ctDNA assay, clinical test volume, clinical revenue, Medicare coverage for breast and lung cancer surveillance, and the shift toward commercial adoption of MRD testing.
News also covers clinical data presentations and publications in oncology settings, including breast, lung and colorectal cancer, as well as product features such as Real-Time Variant Tracker for therapy-resistance monitoring. Other recurring items include quarterly results, financial guidance, biopharma research applications and governance or management changes tied to the company’s precision oncology strategy.
Personalis (Nasdaq: PSNL) has published groundbreaking study results in Annals of Oncology, showcasing their NeXT Personal® ultra-sensitive ctDNA blood test for breast cancer detection. The study, conducted with The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust, analyzed 78 early-stage breast cancer patients.
Key findings demonstrate that NeXT Personal detected cancer recurrence with 100% accuracy, approximately 15 months ahead of standard imaging, with some cases detected up to 5 years earlier. The test utilizes whole-genome sequencing to identify up to 1,800 tumor variants, achieving sensitivity down to 1 part per million of ctDNA. Notably, 39% of detections occurred in the ultra-sensitive range below 100 PPM.
The study included patients with triple-negative, HER2+, and HR+ breast cancers. Importantly, all patients who tested negative remained disease-free throughout the study period. This research is particularly significant given breast cancer's status as the most common cancer in the U.S., with projected 300,000 new cases and 40,000 deaths in 2024.
Personalis (PSNL) reported full year 2024 revenue of $84.6 million, marking a 15% year-over-year increase. The company delivered 1,441 molecular tests in Q4 2024, up 52% from Q3, and 3,285 tests for the full year compared to 177 in 2023.
Key developments include a $50 million investment from Merck, expanded partnerships with Moderna and Tempus, and submission for Medicare coverage in early-stage breast cancer. The company maintains a strong cash position of $185 million.
For 2025, Personalis projects revenue between $80-90 million, with clinical tests reimbursement expected at $3-10 million. However, gross margin is anticipated to decrease to 21-23% from 32% in 2024, and cash usage is expected to increase to $75-80 million due to investments in their 'Win in MRD' strategy.
Personalis (Nasdaq: PSNL), a company specializing in advanced genomics for precision oncology, has announced its management team's upcoming participation in the TD Cowen's 45th Annual Health Care Conference. The event is scheduled to take place on Monday, March 3, 2025, and will be held at the Boston Marriott Copley Place in Boston, MA.
Personalis (Nasdaq: PSNL), a genomics company focused on cancer, has scheduled the release of its fourth quarter and full year 2024 financial results for Thursday, February 27, 2025. The company will host a conference call and webcast at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time on the same day to discuss the results and recent highlights.
Investors can join the call by dialing 877-451-6152 (domestic) or 201-389-0879 (international). A webinar will be accessible through the Events section of Personalis's investor website. A replay will be available after the call and archived on the company's website.
Personalis (Nasdaq: PSNL), a leading company in advanced genomics for precision oncology, has announced its management team's upcoming participation in the BTIG Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference. The event is scheduled to take place on Tuesday, February 11, 2025, at The Cliff Lodge in Snowbird, Utah.
Personalis (Nasdaq: PSNL) published new results in Nature Medicine from their TRACERx lung cancer study, conducted with London's Francis Crick Institute and University College London. The study utilized NeXT Personal®, an ultra-sensitive test for detecting circulating tumor DNA (ctDNA) in blood samples.
The research analyzed pre-operative blood samples from 171 early-stage non-small cell lung cancer patients. The test demonstrated 100% detection in non-adenocarcinomas and 81% in lung adenocarcinomas (LUAD). Notably, LUAD patients testing negative for ctDNA pre-surgery showed 100% 5-year survival rates, while ctDNA-positive patients had high relapse risks. Even patients with very low ctDNA levels (below 80 PPM) showed high recurrence risks.
The study highlights NeXT Personal's potential in early lung cancer detection and management, particularly significant given lung cancer's position as the second most common cancer in the U.S., with 238,340 new cases and 127,070 deaths projected for 2023.
Personalis (PSNL) reported preliminary unaudited revenue of approximately $84.6 million for full year 2024, marking a 15% increase from 2023's $73.5 million and exceeding previous guidance of $83.0-84.0 million. The company's pharma tests, services, and enterprise sales revenue grew 20% to $77.2 million, despite a 20% decrease in Natera revenue to $25.4 million.
Fourth quarter 2024 revenue was $16.8 million, down 15% year-over-year, primarily due to declining revenue from Natera and VA MVP. The company delivered 1,441 molecular tests in Q4 2024, up 52% from Q3. Cash position stood at approximately $185.0 million, including a $50 million strategic investment from Merck. The company also secured a long-term commercial collaboration with Moderna.
Personalis (NASDAQ: PSNL) announced two significant agreements: a $50 million investment from Merck through private placement stock purchase at $3.56 per share, and a multi-year extension of its collaboration with Moderna. The investment will give Merck approximately 16.5% ownership stake in Personalis, representing about 14 million shares.
The extended collaboration involves Personalis' ImmunoID NeXT Platform® being used for V940/mRNA-4157, an investigational individualized neoantigen therapy being jointly developed by Merck and Moderna. Personalis has been providing its tumor-profiling platform to both companies since the beginning of the V940/mRNA-4157 clinical development program.
Personalis (Nasdaq: PSNL) and Tempus AI (Nasdaq: TEM) have expanded their commercial relationship to benefit the biopharma industry. Originally agreed upon in November 2023, the collaboration aims to bring ultra-sensitive MRD testing to market. The partnership was launched at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, with Tempus serving as the exclusive commercial diagnostic partner for Personalis' NeXT Personal® Dx. This product is designed for broad patient adoption in breast and lung cancers and immunotherapy monitoring across all solid tumors.
Following a positive market reaction, Tempus will now offer Personalis' NeXT Personal MRD product to pharmaceutical and biotech customers. These customers can bundle MRD testing with other Tempus offerings within a given study. Chris Hall, CEO of Personalis, believes that this expansion will accelerate market penetration and capitalize on new opportunities.
Personalis (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, has announced its participation in two upcoming investor conferences. The company will join the Piper Sandler 36th Annual Healthcare Conference on December 3, 2024, featuring a fireside chat at 12:30 PM ET at The Lotte New York Palace. Additionally, Personalis will participate in TD Cowen's Diagnosing Tomorrow: Tools & Technologies for the Next Decade conference on December 12, 2024, contributing to a panel discussion on 'MRD - The Future Tech Stack' at 1:30 PM ET at One Vanderbilt in New York.