On February 2, 2026 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported the publication of a new study in npj Precision Oncology highlighting the power of its ultrasensitive molecular residual disease (MRD) assay, NeXT Personal, in monitoring immunotherapy response across a broad range of advanced cancers.

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The study, titled "Ultrasensitive ctDNA monitoring reveals early predictors of immunotherapy response in advanced cancer," was led by oncology researchers at UC San Diego Moores Cancer Center.

The findings reinforce the NeXT Personal test’s ability to detect circulating tumor DNA (ctDNA) at ultrasensitive levels, providing a window for earlier clinical intervention that other approaches may miss. The NeXT Personal test achieves ultrasensitive detection of small traces of ctDNA from a patient’s blood sample using a personalized approach that tracks up to ~1,800 tumor-specific variants unique to each patient’s tumor.

While immunotherapy has transformed cancer care, only ~10-40% of patients achieve durable benefit, making it critical to monitor how patients are responding to therapy. This interim analysis of the ongoing study includes 39 patients with advanced solid tumors—across nine different cancer types—treated with immune checkpoint inhibitors alone or in combination with other therapies. Key findings include:

Early identification of therapy response: Molecular response—defined by ctDNA dynamics—was detectable early, a median of 23 days after starting immunotherapy. Patients achieving an early molecular response had significantly longer progression-free survival.
Lead time over imaging: For patients whose disease progressed, NeXT Personal identified molecular progression a median of 161 days (over five months) before imaging.
Criticality of the ultrasensitive range in advanced tumors: The study found that even in advanced tumors where ctDNA shedding can be higher, 33% of positive ctDNA detections occurred in the ultrasensitive range (below 100 PPM). These are detections that could be missed with a less sensitive test.
Strong correlation with outcomes: Patients who achieved molecular complete response (ctDNA clearance) had seven times higher overall survival than patients who did not achieve ctDNA clearance.
"We continue to expand the clinical evidence that NeXT Personal can be used to monitor therapy response in advanced cancer patients on immunotherapy," said Richard Chen, M.D., M.S., Chief Medical Officer and Executive Vice President of R&D at Personalis. "This pan-cancer study builds on our recent publication in Clinical Cancer Research, similarly showing the impact of ultrasensitive ctDNA testing in late-stage cancers. With immunotherapy, an important pillar of cancer treatment in advanced cancer patients, the need for better tools to evaluate patient response is increasingly important. These findings show how NeXT Personal and ultrasensitive ctDNA testing can potentially play an important role in impacting care across a broad spectrum of solid tumors."

(Press release, Personalis, FEB 2, 2026, View Source [SID1234662413])

On February 2, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported the submission of its premarket approval (PMA) to the U.S. Food and Drug Administration (FDA) for Signatera CDx for detection of molecular residual disease (MRD) in patients with muscle-invasive bladder cancer (MIBC) who may benefit from treatment with atezolizumab (Tecentriq).

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This submission is supported by data from the randomized, double-blind, phase 3 IMvigor011 clinical trial, which met its primary endpoint and demonstrated the benefits of Signatera-guided therapy in MIBC. In the study, Signatera-positive patients treated with atezolizumab (Tecentriq) had statistically significant and clinically meaningful improvements in disease-free survival and overall survival, compared with placebo. The trial also showed that Signatera-negative patients had a low risk of recurrence without adjuvant immunotherapy. Results were featured in a Presidential Symposium at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress on October 20, 2025, with a concurrent publication in The New England Journal of Medicine.

Bladder cancer is the sixth most common cancer in the United States1 and MIBC represents 20-25% of the newly diagnosed cases.2 Radical cystectomy (with or without neoadjuvant therapy) is curative for approximately half of these patients, but until now it has been very challenging to identify which patients are likely to recur and to offer them effective, personalized therapy while sparing the others from unnecessary treatment.3,4 The IMvigor011 trial, sponsored by Genentech, a member of the Roche Group, was designed to address that challenge.

"Submitting this PMA represents an important step toward making MRD-guided treatment a reality for patients with muscle-invasive bladder cancer," said Alexey Aleshin, M.D., general manager of oncology and corporate chief medical officer at Natera. "If approved, we believe Signatera CDx has the potential to be the first companion diagnostic MRD test that helps guide treatment decisions and improve outcomes for patients."

(Press release, Natera, FEB 2, 2026, View Source [SID1234662414])

On February 2, 2026 Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, reported the launch of a novel blood test that uses advanced flow cytometry methods to assess measurable residual disease (MRD) in patients with the blood cancer myeloma (also called multiple myeloma). Called Quest Flow Cytometry MRD for Myeloma, the new test provides comparable sensitivity as next-generation sequencing methods in detecting residual myeloma*, but at a fraction of the cost, supporting better care and outcomes.

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"Our Flow Cytometry MRD for Myeloma test harnesses cutting-edge science and technology to deliver ultrasensitive insights from a noninvasive blood test, thereby improving care and value for patients and the healthcare system," said board-certified oncologist and hematologist Yuri Fesko, M.D., Senior Vice President and Chief Medical Officer, Quest Diagnostics. "This new test merges this elite performance with improved access, given Quest’s approximately 7,000 phlebotomy sites across the United States, helping to illuminate a path to better health for more patients."

Advancing disease detection for a prevalent blood cancer

Myeloma is a cancer of plasma cells, a type of white blood cell, in which dysregulated growth leads to the creation of abnormal antibodies affecting the blood and bones. About 36,000 new cases of myeloma are diagnosed every year in the United States, and nearly 11,000 patients die of the disease annually, according to the American Cancer Society, making it one of the most common types of plasma cell cancers. While incurable, myeloma can often be treated as a chronic condition using chemotherapy and other personalized treatments and guided by MRD monitoring during and after treatment. Physicians typically assess MRD using flow cytometry methods that detect abnormal cells in bone marrow aspirates, a type of biopsy. In recent years, next-generation sequencing has been deployed on both blood and bone marrow aspirate specimens, improving sensitivity tenfold compared to conventional flow cytometry, but at a higher price point.

The new test from Quest is unique for using next-generation flow cytometry techniques with a level of detection comparable to next-generation sequencing but on noninvasive blood specimens instead of bone marrow aspirates. In addition, the test can be used in situations where a baseline aspirate sample is not available, unlike NGS methods, which require a pre-treatment baseline sample to provide a reference for ongoing monitoring. The test also features five-day specimen stability, compared to three or fewer days by conventional flow cytometry, supporting access when specimen transport to the lab takes several days.

"The enthusiastic response received at the recent American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition upon educating the medical community about the Quest Flow Cytometry MRD for Myeloma test made it clear to me that this assay has the potential to greatly improve the treatment paradigm," said Timothy Looney, PhD, Senior Director, Immuno-Oncology, Quest Diagnostics. "The sensitivity, cost, and sample stability that we can now offer to patients and their care team will help those suffering from this potentially devastating condition."

In addition to supporting clinical care, the Quest Flow Cytometry MRD for Myeloma test is expected to have utility as a response monitoring tool in clinical trials. In January 2026, the FDA provided draft guidance on using MRD as a primary endpoint in trials evaluating drug and biological products to treat patients with multiple myeloma to support accelerated approval.

Quest is a leading provider of oncology testing services, including the Haystack MRD test for assessing MRD in solid tumor cancers. This new offering complements Quest’s comprehensive portfolio of hematopathology and advanced molecular oncology testing and services aiding care and outcomes for patients with cancer.

(Press release, Quest Diagnostics, FEB 2, 2026, View Source,-Enabling-Ultrasensitive-Detection-of-Residual-Disease [SID1234662399])

On February 2, 2026 Theralase Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase" or the "Company"), a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or drug-activated small molecules and their formulations, intended for the safe and effective destruction of various cancers, bacteria and viruses, reported that it has successfully completed its targeted milestone of enrolling and treating 90 patients in a multi-center Phase II clinical study for bladder cancer.

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The Phase II clinical study has a primary endpoint of efficacy, a secondary endpoint of duration of response and a tertiary endpoint of safety, in evaluating light-activated Ruvidar in the treatment of patients diagnosed with Bacillus Calmette-Guérin ("BCG")-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS"), who have failed standard-of-care therapy and are facing radical cystectomy (bladder removal) ("Study II").

The enrollment and treatment of 90 patients achieves the Company’s statistical analysis plan and represents a significant step forward in evaluating a statistically and clinically significant dataset in support of a Health Canada and FDA regulatory approval. In accordance with the clinical protocol, Theralase will enroll and treat any additional patients, who are in or pending screening.

Pending Health Canada and FDA regulatory approval, light-activated Ruvidar represents a potentially transformative, bladder-sparing treatment option for patients with limited alternatives, addressing a significant unmet need in high-risk NMIBC.

Clinical data generated to date continues to demonstrate a strong efficacy, duration of response and favorable safety profile, with a majority of patients achieving durable responses with a single treatment.

Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer of Theralase, stated, "I am pleased that Theralase has completed enrollment of 90 patients in its Phase II registrational clinical study for bladder cancer. This accomplishment allows the Company to complete this study in 2026 and prepare for Health Canada and FDA regulatory approval submissions."

Roger DuMoulin-White, BSc, P.Eng, Pro.Dir, President and Chief Executive Officer of Theralase, added,
"Enrolling and treating 90 patients in our Phase II registration clinical study represents a significant milestone for the Company. With the targeted enrollment now completed, we can focus on compilation of the clinical data for Health Canada and FDA regulatory approval. 2026 will be a pivotal year for the Company as we complete our bladder cancer study, embark on a combinational clinical study for bladder cancer and launch numerous Phase I/II adaptive clinical studies for brain, lung, muscle invasive bladder, pancreatic and colorectal cancers."

About Study II:
Study II utilizes the therapeutic dose of the small molecule Ruvidar, which has been light-activated by the TLC-3200 Medical Laser System. Study II will enroll and treat 90 BCG-Unresponsive NMIBC CIS patients in 12 clinical study sites located in Canada and the United States.

About NMIBC
NMIBC is a form of bladder cancer that is found in the inner layer cells of the bladder and does not invade into or beyond the muscle wall.1 In the United States, bladder cancer is the sixth most common cancer,2 fourth among men,3 and it is estimated that there will be approximately 84,870 new cases of bladder cancer in the U.S. in 2025.3 Historically, 75% of bladder cancer presents as NMIBC.4 In patients with high-risk NMIBC, intravesical BCG remains the first-line standard-of-care; however, approximately one third of patients with NMIBC will not respond to BCG therapy and 50% of those with an initial response will experience recurrence or progression of their disease.5 Current treatment options for BCG-unresponsive patients are very limited and National Comprehensive Cancer Network guidelines recommend cystectomy (partial or complete removal of the bladder).6

About Ruvidar:
Ruvidar is a small molecule activated by light, radiation, sound and/or other drugs, intended for the safe and effective destruction of cancer, bacteria and viruses.

(Press release, Theralase, FEB 2, 2026, View Source [SID1234662400])

On February 2, 2026 Twist Bioscience Corporation (NASDAQ: TWST), a mid-cap growth and value biotech company, reported financial results and business highlights for the first quarter ended December 31, 2025.

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"We’re continuing to build on the momentum we established in fiscal 2025, starting the new fiscal year with our twelfth consecutive quarter of growth. Revenue of $103.7 million exceeded guidance and increased 17% compared to the first quarter of 2025," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "As we continue through the year and beyond, we remain focused on driving toward profitability with consistent revenue growth, gross margins above 50% and disciplined spending to invest in scalable, sustainable growth opportunities while serving more customers, launching more products and expanding our addressable markets."

See "Non-GAAP Information" below for a discussion of the measure adjusted EBITDA.

FISCAL 2026 FIRST QUARTER FINANCIAL RESULTS

•Revenue: Total revenues for the first quarter of fiscal 2026 grew 17% to $103.7 million compared to $88.7 million for the same period of fiscal 2025.
◦DNA Synthesis and Protein Solutions revenue grew 27% to $51.1 million for the first quarter of fiscal 2026 compared to $40.1 million for the same period of fiscal 2025.
◦NGS Applications revenue grew 8% to $52.6 million for the first quarter of fiscal 2026 compared to $48.6 million for the same period of fiscal 2025. Excluding one large customer transitioning an assay from research to commercial, NGS Applications grew 18%.
•Cost of Revenues: Cost of revenues for the first quarter of fiscal 2026 increased to $49.7 million compared to $45.9 million for the same period of fiscal 2025.
•Gross Margin: Gross margin for the first quarter of fiscal 2026 increased to 52.0% compared to 48.3% for the same period of fiscal 2025.

•Research and Development Expenses: Research and development expenses for the first quarter of fiscal 2026 decreased to $17.1 million compared to $21.3 million for the same period of fiscal 2025.
•Selling, General and Administrative Expenses: Selling, general and administrative expenses for the first quarter of fiscal 2026 were $69.7 million compared to $56.2 million for the same period of fiscal 2025.
•Net Loss: Net loss for the first quarter of fiscal 2026 decreased to $30.5 million, or $0.50 per share, compared to $31.6 million, or $0.53 per share, for the same period of fiscal 2025.
•Adjusted EBITDA: Adjusted EBITDA for the first quarter of fiscal 2026 was $(13.4) million compared to $(16.3) million for the same period of fiscal 2025. See the table included in this release for a reconciliation between our adjusted EBITDA and net loss attributable to common stockholders, the most directly comparable GAAP financial measure.
•Cash Position: As of December 31, 2025, the company had approximately $198 million in cash, cash equivalents and short-term investments.

Recent Highlights:

•Shipped products to approximately 2,538 customers in the first quarter of fiscal 2026, versus approximately 2,376 in the same period of fiscal 2025.
•Physically shipped approximately 271,000 genes in the first quarter of fiscal 2026, compared with approximately 205,000 in the same period of fiscal 2025; additional >50,000 genes manufactured for data characterization
•Launched research-grade Plasmid DNA Preps designed to support the advancement of pharmaceutical and biotech customers’ pre-clinical studies.

Fiscal 2026 Financial Guidance

The following statements are based on Twist’s current expectations for fiscal 2026. The following statements are forward-looking, and actual results could differ materially depending on market conditions and the factors set forth under "Forward-Looking Statements" below.

For the full fiscal year 2026, Twist expects:

•Total revenue in the range of $435 million to $440 million, growth of 16% at the midpoint, compared to prior guidance of $425 to $435 million. We expect the revenue increase versus prior guidance to be generally balanced across DSPS and NGS
•Gross margin to be above 52% for fiscal 2026

For the second quarter, Twist expects:

•Total revenue of approximately $107 million to $108 million, growth of approximately 16% percent year over year at the midpoint, with sequential growth driven by key NGS accounts

For the fourth quarter, Twist expects:

•To achieve adjusted EBITDA breakeven for the fourth quarter of fiscal 2026

Non-GAAP Information

This release includes EBITDA and adjusted EBITDA, which are non-GAAP financial measures, for the periods presented. EBITDA is defined as net loss adjusted to exclude interest income, income tax expense and depreciation and amortization. Adjusted EBITDA is defined as net loss adjusted to exclude interest income, income tax expense, depreciation and amortization, other income/expense, net, and stock-based compensation expense. These non-GAAP measures are not in accordance with, or an alternative for, measures prepared in accordance with generally accepted accounting principles (GAAP) and may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures are not based on any comprehensive set of accounting rules or principles. We believe that these non-GAAP financial measures, when considered together with our financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare our results from period to period and to our forward-looking guidance, and to identify operating trends in our business. However, non-GAAP information is not superior to financial measures calculated in accordance with GAAP, is presented for supplemental informational purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with GAAP. A reconciliation table of the most comparable GAAP financial measure to the non-GAAP financial measures is included at the end of this press release.

A reconciliation of adjusted EBITDA for the fourth quarter of fiscal 2026 to a corresponding GAAP financial guidance measure is not available on a forward-looking basis because the Company does not provide guidance on GAAP net loss and is not able to present the various reconciling cash and non-cash items between GAAP net loss and adjusted EBITDA without unreasonable effort. In particular, stock-based compensation expense is impacted by the Company’s future hiring and retention needs, as well as the future fair market value of its common stock, all of which is difficult to predict and is subject to change. The actual amount of these expenses during the fourth quarter of fiscal 2026 will have a significant impact on Twist’s future GAAP financial results.

Conference Call Information

The company plans to hold a conference call and live audio webcast for analysts and investors at 8:00 a.m. Eastern Time today to discuss its financial results and provide an update on the company’s business. The conference call will be webcast live through the Investor Relations section under the "Company" tab at www.twistbioscience.com. Those parties interested in participating via telephone must register on the Company’s Investor Relations website or by clicking here. Upon registration, all telephone participants will receive the dial-in number along with a unique PIN number that can be used to access the call. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. The webcast replay will be available for two weeks.

(Press release, Twist Bioscience, FEB 2, 2026, View Source [SID1234662401])