Aarskog Syndrome

New analyses from phase 3, long-term, open-label, repeat-dose study of VALTOCO® (diazepam nasal spray) CIV will be presented Additional presentations explore anticipatory anxiety of seizures, short-term impacts of seizures on daily life and comparison of treated versus untreated seizure clusters SAN DIEGO, Dec. 1, 2023 /PRNewswire/ -- Neurelis, Inc., today announced that the company will present six poster presentations at the American Epilepsy Society (AES) Annual Meeting held in Orlando, Florida from December 1 – 5, 2023. Two of the presentations include new analyses of data from the completed long-term phase 3 open-label, repeat-dose safety study of diazepam nasal spray (VALTOCO®) for the treatment of seizure clusters in patients with epilepsy aged ≥6 years, evaluating timing, safety, and effectiveness of treatment. A third presentation focuses on the further assessment of diazepam in a novel preclinical model dosing strategy with potential application for further in vivo studies. Additional presentations explore the concept of anticipatory anxiety of seizures (AAS) through literature review, comparison of treated and untreated seizure clusters in a retrospective analysis from the SeizureTracker® database, and the short-term impact of seizures beyond the seizure itself. "Our ultimate goal is to improve health outcomes by addressing gaps in seizure cluster treatment and control," said Adrian L. Rabinowicz, M.D., Chief Medical Officer. "The data presented this year at the AES annual meeting demonstrate our ongoing commitment to improving the future of epilepsy care by advancing meaningful, patient-focused treatment outcomes for people with epilepsy." "Neurelis is at the forefront of epilepsy research, as evidenced by the wide breadth of data presented at this year's AES annual meeting," said Enrique Carrazana, M.D., Neurelis Senior Vice President, Strategic Initiatives. "We look forward to sharing our latest advances and insights with our colleagues who strive to improve care and outcomes for people with epilepsy, particularly those who experience frequent seizure activity and have a high unmet need." Poster Session Details Poster Session 2: Sunday, December 3rd, 10:00 AM – 4:00 PM ET "Characterization of a Novel Repeat-Dosing Model for Preclinical Diazepam Studies" (POSTER #2.245, Session 2) A novel preclinical repeat-dosing study of diazepam (DZP) in rats was conducted to identify a dosing strategy for in-life efficacy studies in preclinical models. Results showed sustained and measurable DZP levels in plasma and brain, which were similar to levels observed in humans. Brain-to-plasma ratios indicate an increase of diazepam accumulation in the brain with the repeat-dosing paradigm, suggesting that diazepam may be long-acting at the site of action. The results also support that this dosing paradigm could be used as part of in-life efficacy studies of diazepam. "Comparison of Safety and Effectiveness of Diazepam Nasal Spray in Male and Female Patients: Post Hoc Analysis of Data from a Phase 3 Safety Study" (POSTER #2.264, Session 2) In this post hoc analysis from a long-term safety study, the safety and effectiveness by sex of diazepam nasal spray, including use of second doses and time between seizure clusters (SEIzure interVAL [SEIVAL]), was evaluated. The safety profile and use of second doses as a proxy for effectiveness was generally similar between male and female patients. Females and males also both demonstrated significant increases in mean SEIVAL between the beginning and end of the treatment period, showing similar patterns over time. These results suggest that potential sex differences in benzodiazepine pharmacokinetics and/or pharmacodynamics did not meaningfully influence outcomes associated with intermittent use of diazepam nasal spray. "Shorter Time to Treatment Is Associated with Faster Time to Termination of Seizure Clusters in Multiple Subpopulations Treated with Diazepam Nasal Spray" (POSTER #2.265, Session 2) This post hoc analysis from the long-term safety study of diazepam nasal spray evaluated temporal patterns in treated seizure clusters in relation to time to seizure termination. Data showed shorter time to diazepam administration was associated with more rapid seizure cluster termination, a finding applicable to multiple populations including the overall study population, a group with a large number of treated seizure clusters, and adults and pediatric patients. Results of this analysis reinforce the value of prompt recognition and treatment intervention, which may help minimize risk of injury and additional healthcare utilization and potentially increase patients' and caregivers' sense of empowerment. "Importance of Prompt Treatment of Seizure Emergencies: Benefits Beyond Prevention of Status Epilepticus" (POSTER #2.295, Session 2) A systematic review characterized the short-term burden of seizures and discussed the potential benefit of acute treatment to reduce seizure burden apart from preventing status epilepticus. Acute treatment of seizure emergencies, guided by a seizure action plan, may facilitate a return to normal self/daily activities and reduce healthcare resource utilization and is important to prevent progression to status epilepticus. The rationale in support of prompt treatment for seizure emergencies appears to extend beyond prevention of status epilepticus to include outcomes that reduce the impact of seizures on daily life. Poster Session 3: Monday, December 4th, 8:00 AM – 2:00 PM ET "Exploring Anticipatory Anxiety of Seizures in Patients with Epilepsy" (POSTER #3.247, Session 3) A subset of people with epilepsy may experience Anticipatory Anxiety of Seizures (AAS), a distinct psychiatric entity characterized by a pathological process that includes fear of having seizures and associated avoidance behaviors. A literature search retrieved studies that addressed AAS and detailed potential pathologic mechanisms. Possible tools to screen for AAS were also explored. The analyses revealed that there is currently no validated screening tool for AAS, however a portion of the Epilepsy Anxiety Survey Instrument may be applicable. Additionally, review of published studies indicate recognition and treatment of AAS may be integral to comprehensive management of patients with epilepsy, and further investigation of the impact of AAS on these patients is needed. "Timing Of Rescue Medication Administration and Seizure Cluster Termination" (POSTER #3.283, Session 3) Analysis of data from a large, online database of patient/caregiver-reported seizures (SeizureTracker®) for three time intervals (≥2 seizures in 4 hours, 6 hours, or 24 hours) shows that treated seizure clusters were found to be associated with significantly fewer seizures per cluster than untreated seizure clusters. In addition, the time between seizure clusters was longer for treated seizure clusters. These results support the hypothesis that administration of rescue medications early in seizure clusters, once detected, is associated with earlier termination of seizure clusters and suggest a potential treatment effect beyond acute termination of seizure clusters. VALTOCO, a nasal spray for acute treatment of episodes of frequent seizure activity in adult and pediatric patients 6 years of age and older, was approved by the U.S. Food and Drug Administration (FDA) on Jan. 10, 2020. About Neurelis Neurelis, Inc., is a neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and orphan neurologic disorders characterized by high unmet medical need. In 2020, the FDA approved Neurelis' VALTOCO® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from an individual's usual seizure pattern in adult and pediatric patients 6 years of age and older. VALTOCO is a proprietary formulation of diazepam incorporating the science of INTRAVAIL®. Intravail's transmucosal absorption enhancement technology enables the noninvasive delivery of a broad range of protein, peptide and small-molecule drugs. In its approval of VALTOCO, the U.S. Food and Drug Administration also granted Neurelis Orphan Drug Exclusivity and recognized VALTOCO's intranasal route of administration as a clinically superior contribution to patient care over the previously approved standard-of-care treatment (a rectal gel formulation of diazepam). For more information on VALTOCO, please visit . In addition, Neurelis is developing NRL-1049 (previously known as BA-1049), an investigational, Phase I stage small molecule Rho kinase (ROCK) inhibitor, for the treatment of cerebral cavernous malformations (CCMS), a rare disorder of the central nervous system (CNS). For more information on Neurelis, please visit . For the latest scientific information on VALTOCO, please visit . Important Safety Information about VALTOCO: Indication VALTOCO® (diazepam nasal spray) is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 6 years of age and older. WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. The use of benzodiazepines, including VALTOCO, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing VALTOCO and throughout treatment, assess each patient's risk for abuse, misuse, and addiction. The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although VALTOCO is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of VALTOCO may precipitate acute withdrawal reactions, which can be life-threatening. For patients using VALTOCO more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue VALTOCO. Contraindications: VALTOCO is contraindicated in patients with: Hypersensitivity to diazepam Acute narrow-angle glaucoma Central Nervous System (CNS) Depression Benzodiazepines, including VALTOCO, may produce CNS depression. Caution patients against engaging in hazardous activities requiring mental alertness, such as operating machinery, driving a motor vehicle, or riding a bicycle, until the effects of the drug, such as drowsiness, have subsided, and as their medical condition permits. The potential for a synergistic CNS-depressant effect when VALTOCO is used with alcohol or other CNS depressants must be considered, and appropriate recommendations made to the patient and/or care partner. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including VALTOCO, increase the risk of suicidal ideation and behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or unusual changes in mood or behavior. Glaucoma Benzodiazepines, including VALTOCO, can increase intraocular pressure in patients with glaucoma. VALTOCO may only be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. VALTOCO is contraindicated in patients with narrow-angle glaucoma. Neonatal Sedation and Withdrawal Syndrome Use of VALTOCO late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate. Monitor neonates exposed to VALTOCO during pregnancy or labor for signs of sedation and monitor neonates exposed to VALTOCO during pregnancy for signs of withdrawal; manage these neonates accordingly. Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative VALTOCO is not approved for use in neonates or infants. Serious and fatal adverse reactions, including "gasping syndrome," can occur in neonates and low-birth-weight infants treated with benzyl alcohol–preserved drugs, including VALTOCO. The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. Adverse Reactions The most common adverse reactions (at least 4%) were somnolence, headache, and nasal discomfort. Diazepam, the active ingredient in VALTOCO, is a Schedule IV controlled substance. To report SUSPECTED ADVERSE REACTIONS, contact Neurelis, Inc. at 1-866-696-3873 or FDA at 1-800-FDA-1088 (). Please read full Prescribing Information , including Boxed Warning. Contacts: Neurelis: Brittany Bradrick, Chief Operating Officer and Chief Financial Officer, +1 858 251 2135 Media: Glenn Silver, FINN Partners, +1 646 871 8485 SOURCE Neurelis, Inc.

Mainz Biomed’s proprietary nucleic acid extraction and PCR process proved to be highly effective Two mRNA biomarkers found to be particularly valuable in detecting disease signals in advanced adenoma samples eAArly DETECT clinical trial evaluating these biomarkers with fresh samples reporting results mid-year 2023 Results of eAArly DETECT will inform possible inclusion in U.S. Pivotal Clinical Trial (ReconAAsense) assessing Company’s CRC detection test ReconAAsense represents an opportunity to achieve gold standard status for self-administered colorectal cancer (CRC) screening BERKELEY, Calif. and MAINZ, Germany, March 29, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today results of an independent feasibility study conducted in collaboration with members of the Early Detection Research Network (EDRN) to evaluate the Company’s portfolio of five novel gene expression (mRNA) biomarkers acquired from Université de Sherbrooke in January, 2022. Data results highlights from this feasibility study include: Mainz’s proprietary nucleic acid extraction process and PCR process is robust and highly reliable - able to consistently obtain DNA and mRNA from patient specimens that were stored for greater than 15 years Two mRNA biomarkers proved powerful in detecting disease signals from these aged specimens Able to detect signals from samples of known colorectal cancer (CRC) patients deemed to have higher levels of CRC-specific transcripts, and from specimens of AA patients where disease is in the early stage and thus CRC-specific transcripts are fewer and harder to detect In univariate analysis, demonstrated statistically significant differences between: CRC specimens and controls p=0.0002 and p=0.001, respectively and more importantly, Advanced adenoma (AA) specimens and controls p=0.0005 and p=0.07 (trend), respectively “I am extremely pleased with the study’s result as this outcome is exactly what the Mainz team envisioned when acquiring this portfolio of biomarkers, as it is well documented in the medical community that accurate and early detection of CRC and precancerous adenomas plays an integral role in saving lives,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “We now await the mid-year 2023 results of our eAArly DETECT clinical trial evaluating these biomarkers prospectively with fresh, stabilized samples from enrolled patients versus frozen stool samples from up to 15 years ago. We are keen to review the composite of results from both studies to determine which biomarkers are finally selected for integration into our ReconAAsense U.S. pivotal trial for PMA approval. With a way to diagnose both CRC and AA, Mainz has the potential to transform self-administered CRC screening by bringing to market the best-in-class diagnostic test.” In Sherbrooke’s pioneering work, researchers tested a battery of novel transcriptional biomarkers using samples obtained from patients diagnosed with CRC or as having an advanced adenoma (“AA”), a type of precancerous polyp, and identified a subset of mRNA biomarkers that provided the greatest sensitivity and specificity of detection (Herring et al. 2021). Mainz specifically selected those RNA biomarkers which demonstrated not just the ability to detect a disease signal from samples of patients who were known to have colorectal cancer, but also the unique potential to identify a signal from samples of patients with AA. The power to detect a disease signal in samples from patents with AA can change the entire CRC diagnosis landscape because AA often progresses to CRC, but if treated at the appropriate time AA is curable, CRC can be prevented. Knowing how fragile mRNA can be, all of Sherbrooke’s research on the mRNA biomarkers was performed using fresh and retrospective stool samples allowing for high quality mRNA extraction, and best-in-class RT-PCR. However, real world CRC testing is often performed with suboptimal patient specimens. Therefore, as part of this feasibility analysis of the “Sherbrooke biomarkers,” the Company utilized banked frozen stool samples provided by the Great Lakes-New England Clinical and Validation Center (GLNE CVC) of the Early Detection Research Network (EDRN). The GLNE includes investigators at several top-tier medical centers including MD Anderson Cancer Center, Dana Farber Cancer Institute, the University of Michigan, NYU Langone Health, the University of Minnesota and others, and is part of the renowned research consortium funded by the Division of Cancer Prevention at the National Cancer Institute (NIH) comprising over 300 academic and industry investigators. The Sherbrooke feasibility protocol involved evaluating 150 samples (50 disease free controls, 51 diagnosed with AA, and 49 from subjects diagnosed with CRC). These banked raw stool specimens were stored for over 15 years at -70°C without any additional stabilization and were exclusively preserved by the surrounding deep freeze temperature. Researchers at the Company first extracted nucleic Acid (DNA and mRNA) and proteins from these samples using their proprietary extraction protocols. Next each extracted mRNA sample was analyzed with the newly acquired RNA biomarkers. The mRNA results were compared with results from fecal immunochemical test (FIT) analysis, hDNA, and mutational status of KRAS and BRAF genes, that together comprise ColoAlert® the Company’s CE-marked, easy-to-use detection test for CRC which is being marketed across Europe and in select international territories. One fascinating outcome from the study was the effectiveness of Mainz’s proprietary extraction technology as it achieved 100% accuracy in detecting nucleic acids from stool samples that have been without stabilization for over 15 years. The Company now awaits results from the eAArly DETECT clinical trial which commenced enrollment in December of 2022 and remains on track to report results in mid-year 2023. This multi-center feasibility study is enrolling 250 subjects across 25 sites in the U.S. To participate in the study, subjects must be of either average risk for colon cancer or be suspected/known to have an advanced adenoma or CRC. Once eAArly DETECT is completed and the data analyzed, Mainz will compare outcomes from both feasibility studies and select biomarkers for inclusion in the ReconAAsense pivotal trial which will form the data package for review by the U.S. Food and Drug Administration (FDA) to achieve marketing authorization for the Company’s next generation CRC test. ReconAAsense, is a prospective clinical study that will include approximately 15,000 subjects from 150 sites across the United States. It will examine the clinical performance of the Mainz Biomed Colorectal Cancer Screening Test. The study objectives include calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) in average-risk subjects for CRC and AAs. Once enrollment commences, ReconAAsense will continue until at least 73 evaluable subjects are enrolled that are diagnosed with colorectal cancer. To learn more about ReconAAsense please visit clinicaltrials.gov (Identifier: NCT05636085) About ColoAlert ColoAlert, Mainz Biomed’s flagship product, delivers high sensitivity and specificity in a user-friendly, at-home colorectal cancer (CRC) screening kit. This non-invasive test can be indicative of tumors as determined by analyzing tumor DNA, offering better early detection than fecal occult blood tests (FOBT). Based on PCR-technology, ColoAlert detects more cases of colorectal cancer than other stool tests and allows for an earlier diagnosis (Gies et al., 2018). The product is commercially available in select EU countries through a network of leading independent laboratories, corporate health programs, and via direct sales. To receive marketing approval in the US, ColoAlert will be evaluated in the FDA-registration trial ‘ReconAAsense’. Once approved in the US, the Company’s commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country. About Colorectal Cancer Colorectal cancer (CRC) is the third most common cancer globally, with more than 1.9 million new cases reported in 2020, according to World Cancer Research Fund International. The US Preventive Services Task Force recommends that screening with stool DNA tests such as ColoAlert should be conducted once every three years starting at age 45. Each year in the US, 16.6 million colonoscopies are performed. However, roughly one-third of US residents aged 50-75 have never been screened for colon cancer. This gap in screening represents a $4.0B+ total market opportunity in the US. About Mainz Biomed NV Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. ColoAlert is currently marketed across Europe. The Company is running a pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook. For media inquiries, please contact press@mainzbiomed.com In Europe: MC Services AG Anne Hennecke/Caroline Bergmann +49 211 529252 20 mainzbiomed@mc-services.eu In the US: Spectrum Science Melissa Laverty/Valerie Enes +1 540 272 6465 mainz@spectrumscience.com For investor inquiries, please contact info@mainzbiomed.com Forward-Looking Statements Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on May 5, 2022. The Company’s SEC filings are available publicly on the SEC’s website at . Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.

Jan. 12, 2021 14:00 UTC New results from the AI-EMERGE® study show Freenome’s multiomics blood test can detect colorectal advanced adenomas at 41% sensitivity and 90% specificity, which is comparable to or better than currently available non-invasive tests for colorectal cancer screening. This data, to be presented at ASCO-GI, build on previously reported data from a separate cohort that showed Freenome’s multiomics blood test can detect early-stage colorectal cancer (stage I/II) at 94% sensitivity and 94% specificity. A multiomics approach enabled detection of twice as many advanced adenomas as single assay approaches. SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Freenome, a privately held biotechnology company that has pioneered a comprehensive multiomics platform for early cancer detection with a routine blood draw, today announced that it will be presenting results for the detection of colorectal advanced adenomas from its prospective, multi-center clinical study, AI-EMERGE®, at the American Society of Clinical Oncology’s Gastrointestinal Cancers (ASCO-GI) Symposium on January 15th, 2021. The data from a pre-defined subset of AI-EMERGE® (n=522) showed that Freenome’s novel multiomics blood test for colorectal cancer screening was able to detect colorectal advanced adenomas (AAs) with a sensitivity of 41% at a specificity of 90%. Compared with the FDA-approved mSEPT9 (methylated septin 9) blood test, Freenome’s multiomics blood test showed much higher sensitivity (41% vs. 22%)1 for detecting AAs. When compared to currently available stool-based tests, the test demonstrated much higher AA sensitivity than a fecal immunochemical test, or FIT (41% vs. 24%) and comparable AA sensitivity to FIT-DNA (41% vs. 42%)2. These new results augment previously reported data, which showed that Freenome’s multiomics blood test can detect early-stage colorectal cancer (stage I/II) at a sensitivity of 94% and specificity of 94%3. A blood test with performance characteristics comparable or better than fecal tests can improve access and drive better adherence, facilitating early detection, and ultimately reducing mortality. “The ability to detect advanced adenomas is incredibly important because we can remove them before they become cancerous,” said Aasma Shaukat, M.D., M.P.H., Chief of Gastroenterology at Minneapolis VA Health Care System and Professor of Medicine, University of Minnesota. “That means with a blood test such as Freenome’s multiomics test, not only can we detect colorectal cancer, but we may be able to prevent colorectal cancer altogether.” “This data reflects significant progress in the development of blood-based cancer screening,” added Carol Burke, M.D., Vice Chair of the Department of Gastroenterology, Hepatology, and Nutrition and Head of the Section of Polyposis in the Sanford R. Weiss MD Center for Hereditary Colorectal Cancer at Cleveland Clinic, Cleveland Ohio. “A blood test that can detect both advanced adenomas and early stage colorectal cancer could be an important tool in the fight against colorectal cancer.” Importantly, these new results also showed that Freenome’s multiomics blood test detected twice as many advanced adenomas as cell-free DNA methylation-only or single-protein approaches. Freenome’s multiomics blood test differs from single assay approaches because it combines signatures from both tumor- and non-tumor- (e.g., immune) derived sources. “While tumor-derived signals are abundant in later-stage disease, signals from non-tumor sources predominate in earlier stages,” said C. Jimmy Lin, MD, PhD, MHS, Chief Scientific Officer for Freenome. “That’s why we believe that our multiomics platform, which combines those signals, is critical in the development of next-generation, blood-based cancer screening.” The data and poster for the new results from the AI-EMERGE® study will be available online at at the time of presentation at ASCO-GI on January 15, 2021. About Colorectal Cancer (CRC) and Screening According to the U.S. Centers for Disease Control (CDC), colorectal cancer (CRC) is the second leading cause of death in the United States from cancers that affect both men and women. Both CRC incidence and mortality have declined steadily over the past 30 years, attributable in part to the increasing percentage of adults aged 50–75 years who are up to date with recommended CRC screening. However, only 68.8% of adults aged 50–75 years were up to date with CRC screening in 20184. A CDC study shows that compliance varies based on income, access to health insurance and other factors, including lack of awareness of the need to be screened, being offered colonoscopy only instead of a choice of tests, fear, expense, inability to take time off work, and the perceived undesirable nature of screening tests. About Freenome Freenome is a biotechnology company that has pioneered the most comprehensive multiomics platform for early cancer detection using a routine blood draw, beginning with a colorectal cancer screening test. The company combines its deep expertise in molecular biology with advanced computational biology and machine learning techniques to detect disease-associated patterns among billions of circulating cell-free biomarkers. Freenome is also building a machine learning feedback loop with healthcare providers to leverage real-world data and improve patient care through early detection. Freenome is headquartered in South San Francisco, California. For more information about Freenome, visit and view open positions at freenome.com/careers. 1Timothy Robert Church et al., “Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer,” Gut (February, 2014) 2Thomas F. Imperiale, M.D. et al., “Multitarget Stool DNA Testing for Colorectal-Cancer Screening,” New England Journal of Medicine (April 3, 2014) 3Girish Putcha et al., “Blood-Based Detection of Early-Stage Colorectal Cancer Using Multiomics and Machine Learning,” American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium (January, 2020). Available at 4Djenaba A. Joseph, M.D. et al, “Vital Signs: Colorectal Cancer Screening Test Use — United States, 2018,” Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report, (March 13, 2020)