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Articles by Molika Ashford
GenomeWeb Survey: Enthusiasm for MCED Tests in Research and Clinical Care Despite Evidence Caveats
NEW YORK – Awareness and embrace of multi-cancer early detection (MCED) screening tests has solidified in the genomic research and precision medicine community, based on the results of a survey of GenomeWeb readers.
GenomeWeb Survey: Enthusiasm for MCED Tests in Research and Clinical Care Despite Evidence Caveats
Guardant Health (Shield MCD) Exact Sciences (CancerGuard) Precision Epigenomics (EPISEEK) SeekIn (OncoSeek, SeekIn Care) Singlera Genomics (Panseer) ClearNote Health (Avantect Multi-Cancer) Gene Solutions (SPOT-MAS) 20/20 GeneSystems (OneTest) Proteotype Diagnostics (Enlighten)
Exact Sciences Eyes Future for New Blood-Based Tests Backed By Cologuard Brand
NEW YORK – Exact Sciences on Monday reported on strategies for marketing and expanding access to new tests after significant developments in its blood-based cancer testing portfolio in recent months.
Fanconi Anemia Genetics, Breast Cancer Susceptibility Get Deep Dive From International Researchers
NEW YORK – A new study published Thursday in the American Journal of Human Genetics has demonstrated an improved approach to categorize gene alterations contributing to breast and ovarian cancer risk in the Fanconi anemia (FA) genes BRCA1/2 and PALB2. In the paper, a team of international investigators demonstrated the potential of using an allele severity scoring approach to predict cancer risk in individuals with biallelic or heterozygous BRCA1 or BRCA2 variants.
Guardant Health Enters Multi-Cancer Blood Screening Market as Stock Soars on Q3 Earnings
NEW YORK – Guardant Health said Wednesday that it has opened access to the multi-cancer version of its Shield screening assay, dubbed Shield MCD, through what it called a clinical data collection initiative. The methylation-based blood test, previously available only for colorectal cancer screening, has become a source of "meaningful revenue" for the company about a year into its commercial launch, executives said during a call discussing the firm's third quarter financial results.
Grail's Pathfinder 2 Data Beats Prior Study by Leaps, Raising Hopes for Upcoming UK Readout
NEW YORK – Data presented from Grail's 36,000-person prospective trial Pathfinder 2 presented an even stronger picture of the firm's multi-cancer early detection test performance than prior studies, demonstrating a dramatically higher cancer detection rate with minimal harms and relatively smooth diagnostic resolution for patients with a positive result.
Exact Sciences Claims Modeling Data Supports Cologuard Over Alternatives, but Guardant Objects
NEW YORK – Exact Sciences highlighted new data earlier this month from a modeling study that explored the value of different colorectal screening modalities in terms of their life-year benefit versus their practical burden. Published in the Journal of the National Cancer Institute, the analysis concluded that Exact's stool-based Cologuard Plus test was "efficient" when used at its thrice-yearly recommended interval and in the guideline-endorsed population age range.
Precision Epigenomics Maintains Multi-Cancer Early Detection Focus, Eyes New Applications for Tech
NEW YORK – Precision Epigenomics, a relatively recent entrant to the blood-based cancer screening field, continues to offer its EpiSeek multi-cancer early detection (MCED) assay through concierge medicine clients, but is also leaning in to disease-specific applications where the bar may be lower for making a case for clinical utility.
Precision Epigenomics Maintains Multi-Cancer Early Detection Focus, Eyes New Applications for Tech
NEW YORK – Precision Epigenomics, a relatively recent entrant to the blood-based cancer screening field, continues to offer its EpiSeek multi-cancer early detection (MCED) assay through concierge medicine clients, but is also leaning in to disease-specific applications where the bar may be lower for making a case for clinical utility. As such, the firm is seeking more funding to further pursue clinical validation, COO Richard Bernert said this week.
NEW YORK – After publishing a proof-of-concept study showcasing a machine learning strategy to estimate and quantify the penetrance of disease-associated genetic variants using electronic health records, researchers from Mount Sinai are hopeful that they can further validate the strategy as a broad-scale tool to help understand how changes in the genome contribute to disease.
BillionToOne Sees Future for In Utero Cystic Fibrosis Treatment Guided by NIPT Risk Screening
NEW YORK – Prenatal testing firm BillionToOne recently published the first data that explored the potential of its noninvasive prenatal risk test to identify fetuses at risk of having cystic fibrosis (CF) whose parents might be eligible to try off-label in utero treatment. The existence of off-label in utero CF prescribing has only recently come to light.
Quest's Haystack Oncology Expects Rich MRD Data in Coming Year, Bolstered by Research Partnerships
NEW YORK – Quest Diagnostics-owned liquid biopsy developer Haystack Oncology is expecting in the next year to bring a new wealth of data supporting the ability of its circulating tumor DNA technology for use in minimal/molecular residual disease (MRD) detection across a variety of indications, especially those where its higher sensitivity may give it a boost over other technologies.
Quest's Haystack Oncology Expects Rich MRD Data in Coming Year, Bolstered by Research Partnerships
NEW YORK – Quest Diagnostics-owned liquid biopsy developer Haystack Oncology is expecting in the next year to bring a new wealth of data supporting the ability of its circulating tumor DNA technology for use in minimal/molecular residual disease (MRD) detection across a variety of indications, especially those where its higher sensitivity may give it a boost over other technologies.
Multi-Cancer Detection Tests Haven't Met Evidence Bar for Widespread Use, New Review Concludes
NEW YORK – Based on results of an analysis of existing public data on multi-cancer screening tests, a team from RTI International, the University of North Carolina, and the Ohio State University College of Medicine have concluded that the type of clinical utility evidence physicians might expect for a publicly available test just isn't there yet.
New Data Suggest Potential for Personalis MRD Platform in Neoadjuvant Lung Cancer
NEW YORK – Analysis from a phase III study of neoadjuvant immunotherapy in lung cancer patients has laid a possible path forward for the use of ultrasensitive liquid biopsy — in this case Personalis' NeXT Personal assay — in guiding the use of neoadjuvant immunotherapy for patients with intermediate-stage lung cancer.
Following IP Win Against Natera, NeoGenomics Back on Track for Radar MRD Commercialization
NEW YORK – Following its win in court over Natera last week, NeoGenomics believes it can pick up where it left off a year ago.
Following IP Win Against Natera, NeoGenomics Back on Track for Radar MRD Commercialization
NEW YORK – Following its win in court over Natera last week, NeoGenomics believes it can pick up where it left off a year ago. At that time, the firm received a permanent injunction in a patent infringement suit brought against it by Natera, preventing it from continuing to market its Radar minimal residual disease (MRD) platform. Last Friday, Neogenomics announced that it had won a sought-after summary judgement in a countersuit seeking to invalidate the purportedly infringed patents.
Stanford PGx Program Expands to Primary Care Population With Long-Read Sequencing Panel Original
NEW YORK – Stanford Health Care (SHC) has expanded its pharmacogenomics program to a broader population of primary care recipients to show that an institutional model can demonstrate the clinical value of guiding drug prescriptions based on genomic sequencing. SHC initially moved into PGx with single-gene testing of patients presenting with signs of a stroke. This then progressed to a pilot program of a new broad panel in older adults earlier this year.
Agendia Registry Data Reinforce MammaPrint Utility, Company Eyes New Indications
NEW YORK – With new real-world evidence reinforcing the predictive ability of its MammaPrint risk assessment test, Agendia said this week that it believes it can continue to grow market share, continuing a trend fueled by its move several years ago to market the test with a paired subtyping assay called BluePrint.
Cancer Screening Based on RNA Changes Could Boost Sensitivity, New Study Data Shows
NEW YORK – Results of a new study published Wednesday in Nature Biotechnology have excited investigators hoping to improve the ability of blood tests to detect certain cancers at their earliest stages.
Exact Sciences Freenome CRC Screening Acquisition Draws Scrutiny as Q2 Revenues Rise 16 Percent
NEW YORK – Exact Sciences simultaneously released its second quarter 2025 revenues and announced its move to acquire rights to Freenome's single indication, blood-based colorectal cancer screening test from Freenome after the close of the market on Wednesday.
Guardant Anticipates Growing MRD Applications, Raises Full-Year Revenue Guidance
NEW YORK – Guardant health is anticipating much broader application of its minimal residual disease assay, Reveal, beyond its currently reimbursed indication for use in colorectal cancer patients after surgical removal of their tumors. The firm's co-CEO Helmy Eltoukhy said on Wednesday during a call with investors that Guardant recently submitted data to Medicare's MolDx program to support reimbursement in a new breast cancer indication.
UPDATE: NeoGenomics Seeks to Reassure Investors After Slashing Full-Year Guidance
This story has been updated from a previous version to include comments made by NeoGenomics CEO Tony Zook during an earnings call.
UPDATE: NeoGenomics Seeks to Reassure Investors After Slashing Full-Year Guidance
This story has been updated from a previous version to include comments made by NeoGenomics CEO Tony Zook during an earnings call. NEW YORK – NeoGenomics' first-year CEO Tony Zook on Tuesday sought to reassure investors that improvements are on the way after the company revised its full-year revenue and earnings guidance downward while reporting a 10 percent year-over-year increase in its second quarter revenues, causing its stock price to tumble more than 25 percent.
Scipher Medicine Expands Dx Focus to Data-Driven Precision Medicine Development
NEW YORK – After about a year under new leadership, Scipher Medicine, which developed and markets one of the only molecular assays to aid treatment decisions in rheumatoid arthritis, is making progress in its attempt to advance personalized medicine across a variety of non-oncology disease areas.
New Data Supports Caris Life Sciences' Platform for Cancer Detection and Monitoring Applications
NEW YORK – Caris Life Sciences, which last month raised nearly $500 million in an initial public offering of stock, has been building a business for several years in comprehensive genomic profiling for cancer, and a new study published last week has showcased its platform's ability to not only inform therapeutic decision-making but also detect developing tumors and monitor lingering or reemerging disease in patient blood samples.
Independent Study Validates PathomIQ AI Digital Pathology Platform for Prostate Cancer Prognosis
NEW YORK – New data published last week in JCO Clinical Cancer Informatics has provided added evidence for the accuracy of AI Pathology firm PathomIQ's technology in assessing post-treatment prostate tissue slide images to predict which cancer patients are at risk of a biochemical recurrence.
Wholomics Lays Path for Metabolomic Platform in Multi-Cancer Detection, Single Tumor Applications
NEW YORK – Wholomics, a startup founded by investigators from who started their work at Dana Farber and University College London, aims to join the ranks of molecular cancer detection test-makers with a unique approach that it believes can improve sensitivity for early-stage tumors.
Wholomics Lays Path for Metabolomic Platform in Multi-Cancer Detection, Single Tumor Applications
NEW YORK – Wholomics, a startup founded by investigators from who started their work at Dana Farber and University College London, aims to join the ranks of molecular cancer detection test-makers with a unique approach that it believes can improve sensitivity for early-stage tumors.
ClearNote Health Nears Commercial Pivot Point for Pancreatic Cancer Detection Test
NEW YORK – ClearNote Health has begun a randomized prospective study in collaboration with the UK National Health Service designed to confirm the clinical validity of its pancreatic cancer early detection test and demonstrate its clinical utility in identifying emerging pancreatic cancer in patients with new-onset type II diabetes.
Medicover Genetics Takes Aim at Minimal Residual Disease Diagnostics With Hybrid Capture Platform
NEW YORK – Medicover Genetics, an internal diagnostics arm of Swedish n healthcare firm Medicover, has made its first foray into the molecular/minimal disease testing space as it seeks to expand its existing portfolio of genomic profiling products.
New Data at ASCO Showcase Efforts to Use Liquid Biopsy to Guide Adaptive Cancer Therapy
NEW YORK – New research presented this week at the annual meeting of the American Society for Clinical Oncology showcased some early efforts to use liquid biopsy testing to adapt cancer treatment in real time, in this case in patients with head and neck tumors.
MCED Developers Share New Data at ASCO as Stakeholders Weigh Harms and Benefits
NEW YORK – This year's annual meeting of the American Society of Clinical Oncology featured new data from a slew of test developers advancing multi-cancer early detection (MCED) technologies, alongside tactful discussion including oncologists and patient advocates acknowledging continued uncertainty about the true utility of these assays.
ASCO Data on Personalis Assay Suggests Role for ctDNA MRD Testing in Cervical Cancer
NEW YORK – New data presented this week at the annual meeting of the American Society of Clinical Oncology in Chicago has set the stage for the potential future use of molecular residual disease testing to prognosticate and personalize treatment of cervical cancer.
New Grail Publication Explores Optimal Liquid Biopsy MCED Test Interval for Mortality Impact
NEW YORK – Multi-cancer early detection (MCED) firm Grail published a new study on Thursday that expands on earlier modeling work to analyze the impact of different testing intervals on the ability of its Galleri circulating tumor DNA (ctDNA) assay to shift cancer diagnoses across a population to earlier, more treatable stages.
Veracyte Q1 Revenues up 18 Percent, Driven by Core Tests
NEW YORK – Veracyte said Wednesday that its first quarter 2025 revenues were up 18 percent compared to the same quarter of 2024.
Veracyte Q1 Revenues up 18 Percent, Driven by Core Tests
NEW YORK – Veracyte said Wednesday that its first quarter 2025 revenues were up 18 percent compared to the same quarter of 2024. The firm's total revenues for the period ended March 31 were $114.5 million compared to $96.8 million in Q1 2024 and beating analysts' average estimate of $110.9 million Testing revenue was $107.3 million, up 19 percent from $90.3 million in the year-ago quarter, driven by the firm's Decipher Prostate and Afirma tests.
Personalis Q1 Revenues up 6 Percent as Firm Anticipates First MRD Reimbursement Wins
NEW YORK – Personalis said Tuesday that its total revenues for the first quarter of 2025 were up 6 percent year over year, driven by growth in revenue from pharma tests and services, as well as added population sequencing business from the US Department of Veterans Affairs' Million Veterans Program.
New Multi-Cancer Screening Research Highlights Diversity of Potential Biomarkers
NEW YORK – Presentations at last week's annual meeting of the American Association for Cancer Research suggest that there are still numerous stones unturned in terms of methods and biomarker targets for multi-cancer early detection (MCED).
New Multi-Cancer Screening Research Highlights Diversity of Potential Biomarkers
NEW YORK – Presentations at last week's annual meeting of the American Association for Cancer Research suggest that there are still numerous stones unturned in terms of methods and biomarker targets for multi-cancer early detection (MCED).
Guardant Health Builds Data Across Liquid Biopsy Menu, Ups Full-Year Guidance on Strong Q1 Earnings
NEW YORK – Guardant Health this week heralded a slew of new data supporting its liquid biopsy tests presented at the annual meeting of the American Association for Cancer Research. Separately, the firm reported that its Q1 revenues grew 21 percent year over year, driven by growth in all of its business segments and prompting the firm to increase its full-year financial guidance.
New Data Promising for Veracyte on Path to Launch Whole-Genome Sequencing MRD Test
NEW YORK – Veracyte is in the midst of an effort to prove out the minimal residual disease technology adopted with its acquisition of C2i Genomics last year, and said last week that new data presented at the European Association of Urology Congress have left it confident that it will be able to launch the test for bladder cancer monitoring in the first half of 2026. The C2i approach is tumor informed, akin to tests developed by firms like Natera, Inivata (part of NeoGenomics), and others.
Guardant Health Builds Data Across Liquid Biopsy Menu, Ups Full-Year Guidance on Strong Q1 Earnings
NEW YORK – Guardant Health this week heralded a slew of new data supporting its liquid biopsy tests presented at the annual meeting of the American Association for Cancer Research. Separately, the firm reported that its Q1 revenues grew 21 percent year over year, driven by growth in all of its business segments and prompting the firm to increase its full-year financial guidance.
Personalis Ultrasensitive MRD Test Demonstrates Value, Superiority in New AACR Data
NEW YORK – New data presented at the annual meeting of the American Association for Cancer Research this week has further cemented the value of Personalis' ultrasensitive minimal residual disease (MRD) platform in colorectal cancer, with other studies continuing to add evidence for superiority of the approach over more targeted test platforms.
NeoGenomics Underscores Clinical Testing Strength as Q1 Revenues Miss Analyst Estimates
NEW YORK – NeoGenomics believes that its clinical testing strength, driven by its expansion into next-generation sequencing, represents a bright future for the company overall despite continued weakness in its non-clinical business, company executives said on Tuesday. The firm reported Tuesday morning that its revenues for the first quarter of 2025 were up 8 percent year over year, driven primarily by higher test volume, which was partially offset by lower non-clinical revenue.
NeoGenomics Underscores Clinical Testing Strength as Q1 Revenues Miss Analyst Estimates
NEW YORK – NeoGenomics believes that its clinical testing strength, driven by its expansion into next-generation sequencing, represents a bright future for the company overall despite continued weakness in its non-clinical business, company executives said on Tuesday.
Age-Related Clonal Hematopoiesis Can Affect Solid Tumor Development, Study Finds
NEW YORK – A team of investigators in the UK, France, and the US has found that clonal hematopoiesis of indeterminate potential (CHIP), an age-related condition, has a role in the evolution of solid tumors.
Fellow Health Looks to Seminal Fluid as Sample Type for Molecular Prostate Cancer Test
NEW YORK – Fellow Health, a company that has established itself in the reproductive health space with a mail-in semen testing service, is now aiming for the molecular diagnostics market, having demonstrated that it can detect DNA fragments in seminal fluid that originate from prostate tissue and could identify prostate cancer.
Mirvie Poised to Launch Preeclampsia Test After Publication of Study in 9,000 Pregnancies
NEW YORK – Pregnancy health firm Mirvie, said this week that it is close to the launch of the first RNA-based blood test to predict pregnant individuals' risk of developing preeclampsia, a hypertensive condition that can lead to pre-term birth, after generating positive data from a study that analyzed more than 9,000 pregnancies.
Cyted Health Aiming for US Expansion With New Validation Study of Barrett's Esophagus Test
NEW YORK – Esophageal cancer testing firm Cyted Health said last week that it has begun enrollment of a new clinical validation study called DETECT-ME to build evidence and drive adoption of its molecular test for Barrett's esophagus and esophageal cancer.
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