Panic Disorder

FRIENDSWOOD, Texas--( BUSINESS WIRE )--Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced new data highlighting the value of its IDgenetix pharmacogenomic (PGx) test in guiding medication recommendations for patients with mental health conditions who are 65 and older. The data will be shared via a poster presentation at the 2024 American Association for Geriatric Psychiatry (AAGP) Annual Meeting, taking place March 15-18 in Atlanta. “Pharmacogenomics has been increasingly used to identify genetic variations associated with drug response; however, its potential in older adults who are more likely to be on multiple medications and experience adverse drug events has not been fully explored,” said Robert Cook, Ph.D., senior vice president of research and development at Castle Biosciences. “This study found that, despite all patients carrying potentially clinically significant genetic variants, one-third of medication recommendations were due to drug-drug interactions and lifestyle factors provided on the IDgenetix report. This is especially important as real-world evidence shows that polypharmacy, taking five or more prescription medications, occurs in more than half of elderly patients. 1 ” Poster Title: Pharmacogenomic Characteristics and IDgenetix-Guided Medication Management for Older Adults with Depression and Anxiety Presenting Author: Raymond A. Lorenz, Pharm.D., BCPP, Castle Biosciences, Inc. Date and Time: Saturday, March 16, from 5-7 p.m. Eastern Time Location: Grand Ballroom, Hanover Hall and Embassy Hall Exhibition Level at the Hyatt Regency Atlanta IDgenetix is an advanced 3-in-1 PGx test that incorporates genetic information, drug-drug interactions and lifestyle factors to produce a report that can help clinicians select optimal medications for their patients with depression, anxiety and other neuropsychiatric illnesses. The study analyzed gender, age and diagnosis, including attention-deficit/hyperactivity disorder, anxiety, bipolar disorder, depression, obsessive-compulsive personality disorder, pain, post-traumatic stress disorder and schizophrenia, from a sample of IDgenetix reports for patients 65 and older (n=737). The most common psychiatric diagnoses for which IDgenetix was ordered included depression and anxiety. Additionally, 58% of the patients in the study were on five or more medications, with an average of seven, at the time of testing. All patients in the study had genetic polymorphisms that could impact medication selection in at least three of the 15 genes on the IDgenetix report. While drug-gene interactions accounted for 66% of all medication recommendations, drug-drug interactions and lifestyle factors accounted for 34% (27% and 7%, respectively), demonstrating the value of the IDgenetix 3-in-1 test in providing tailored guidance to help clinicians select the optimal medications for their patients. About IDgenetix IDgenetix is a pharmacogenomic (PGx) test for depression, anxiety and other mental health conditions designed to analyze a patient’s genetic make-up to guide timely and evidence-based decisions on the optimal drug for each patient. IDgenetix is designed to provide important genetic information to clinicians to help guide personalized treatment plans for their patients, with the potential to help patients achieve a faster therapeutic response and improve their chances of remission by identifying appropriate medications more efficiently than the standard of care trial-and-error approach. IDgenetix provides drug-drug and drug-gene interactions and is supported by a published, peer-reviewed randomized controlled trial that demonstrated clinical utility over the standard of care when physicians used IDgenetix prior to prescribing a medication. IDgenetix is currently reimbursed by Medicare for the following eight mental health conditions: major depressive disorder, schizophrenia, bipolar disorder, anxiety disorders, panic disorder, obsessive-compulsive personality disorder, post-traumatic stress disorder and attention deficit hyperactivity disorder. About Castle Biosciences Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors. Castle’s current portfolio consists of tests for skin cancers, Barrett’s esophagus, mental health conditions and uveal melanoma. Additionally, the Company has active research and development programs for tests in other diseases with high clinical need, including its test in development to help guide systemic therapy selection for patients with moderate-to-severe atopic dermatitis, psoriasis and related conditions. To learn more, please visit www.CastleBiosciences.com and connect with us on LinkedIn , Facebook , X and Instagram . DecisionDx-Melanoma, DecisionDx-CM Seq , DecisionDx-SCC, MyPath Melanoma, DiffDx-Melanoma, TissueCypher, IDgenetix, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UM Seq are trademarks of Castle Biosciences, Inc. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning: the potential of pharmacogenomics to affect medication recommendations for older adults; and the value of the IDgenetix 3-in-1 test in providing tailored guidance to help clinicians select the optimal medications for their patients. The words “believe,” “can” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results obtained in these studies, including with respect to the discussion of our tests in this press release; actual application of our tests may not provide the aforementioned benefits to patients; and the risks set forth under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law. 1. Wang X, Liu K, Shirai K, et al. Prevalence and trends of polypharmacy in U.S. adults, 1999–2018. Glob Health Res Policy . 2023;8(25). https://doi.org/10.1186/s41256-023-00311-4

Teletherapy company Talkspace and virtual opioid use disorder treatment company Bicycle Health are partnering to expand access to virtual care for patients of both companies. Talkspace offers therapy for adults, teens 13 to 17, and couples, as well as psychiatric services and medication management. The platform assists individuals suffering from anxiety, depression, bipolar disorder, OCD, panic disorder, PTSD and postpartum depression. Bicycle offers virtual treatment for opioid use disorder, including medication-assisted treatment like Suboxone. The startup currently operates in 25 states. Patients can set up an introductory call with the startup to determine if Bicycle's treatment would work for them and then schedule a virtual appointment to set a care plan and discuss medication-assisted treatment. Patients can also access health coaching and online support groups. Through the partnership, Talkspace patients will have access to opioid use disorder specialty care, including medication, therapists and recovery coaches. Bicycle Health patients will be able to connect with therapists via chat and speak to mental health providers in areas outside of substance use disorder, such as marriage and family therapists. "Opioid use disorder does not exist in a vacuum. We consider the whole person and their environment when recommending the right care plan to help them achieve stable, lasting recovery," Dr. Brian Clear, chief medical officer at Bicycle Health, said in a statement. "Like patients in all care settings, Bicycle Health patients often experience depression, anxiety or other behavioral conditions beyond their addiction and many will benefit from a relationship with a therapist at Talkspace with expertise to meet their needs. Now, in addition to our own internal therapist team, our clinicians have the ability to connect our patients to a therapist at Talkspace quickly and reliably whenever that’s the right choice for any patient." THE LARGER TREND Bicycle Health recently joined HIMSS TV to discuss its partnership with the Federal Bureau of Prisons to provide individuals released from prison continued access to monthly injections of buprenorphine for opioid use disorder. Last year, the company announced it was collaborating with supermarket chain Albertsons to give the telehealth company's providers the ability to prescribe buprenorphine monthly injections for opioid use disorder that can be filled inside Albertsons pharmacies across 17 states. It also partnered with emergency telehealth provider Tele911 to connect patients to continuing care after an overdose or health crisis. In 2022, the company scored $50 million in a Series B funding round, bringing Bicycle's total raise to $83 million. It scored $27 million in a Series A round announced in 2021. Last year, publicly traded Talkspace announced it signed a $26 million contract with New York City's Department of Health and Mental Hygiene to power NYC Teenspace. The three-year program provides free therapy and self-guided mental health resources to teens 13 through 17. The company also reported it partnered with Finland-based Oura, maker of its namesake health-tracking ring. Through the partnership, Talkspace would allow Oura wearers to share their personalized sleep and daily movement data with Talkspace therapists.

Children and young people throughout the United States continue to face some of the biggest hurdles to receiving timely and appropriate healthcare. As incidence rates of mental health and complex medical conditions rise, the majority of treatment-seeking children face strained health systems, limited affordable treatment options and care that is not personalized to their unique social, cultural and developmental needs. While digital health solutions have begun to offer some hope, there remains a disconnect between innovators and the health systems that they are solving for, resulting in products that do not fit clinical workflows, fail to meet the diverse needs of pediatric patients and ultimately struggle commercially. Meeting user needs A 15-year-old tells her doctor that she feels anxious. The doctor completes a brief assessment and diagnoses the patient with panic disorder. The doctor offers to write a prescription for an anti-anxiety medication and refers the patient to behavioral health services. The patient doesn’t want to start taking medication, so she elects to be matched with a behavioral health service provider and is placed on a waitlist. Digital health technologies offer new forms of hope to young people and their families. Digital health interventions and telehealth are increasing access to mental health and primary care services, making it easier for patients to find support when and where they need it. To ensure that the right patients have access to the right technologies, hospitals are employing tools like AI to streamline patient referrals, provide more accurate diagnoses and gain insights into patient health trajectories that help them better predict and intervene appropriately. Since more still needs to be done to improve outcomes, reduce costs and improve the shortcomings of digital health solutions in pediatric care, healthcare leaders from across the country are calling for greater attention to this space. After struggling to find a therapist for a few months, the patient returns to her doctor. The doctor decides that the patient is a candidate for a new digital therapeutic. After getting set up with the app, the patient goes home and begins her treatment journey, only to find that the app doesn’t seem relatable–and worse–isn’t translated into her preferred language, making it difficult to comprehend. After a few days of trying it, she stops using the app. Incidence rates of mental health conditions, such as depression and anxiety, continue to rise throughout the United States, alongside the complexity of optimally treating patients with diverse needs. As the racial and ethnic makeup of the United States continues to diversify, many families find it difficult to receive culturally competent care, raising the risk of negative health outcomes. At a time when patients and families are increasingly amenable to integrating digital solutions into their care experiences, their specific needs and requirements are often not being met. While digital health can address some of the most pressing issues of patient care, cohesive best practices for developing inclusive, culturally competent and ultimately equitable, solutions are largely absent. To ensure continuity of care the doctor would like to check their patient’s progress in the app and monitor any change in symptoms over time. While a dashboard exists to view this information, it is not integrated into the existing electronic health record system. Since this product is not interoperable with existing infrastructure, the provider is unable to use the dashboard and must wait to check in with their patient at her next 6 month checkup. Rather than streamlining the provider’s process, the digital solution becomes yet another cog in their system. Digital solutions have the potential to improve patient outcomes and supplement care. However, real challenges exist to their integration into clinical workflows and patients’ daily lives. Rather than delivering on the promise of streamlined care, digital solutions often cause fragmentation and interference in clinician’s work because their input and perspectives are unaccounted for. Without taking the unique needs of patients and clinicians into account, digital health solutions will see low uptake, activation rates, and ultimately struggle to succeed at scale. Systematic barriers The patient returns to the doctor after giving up on the app, saying that it was too complicated and difficult to understand. Fortunately, the doctor remembers learning about another app, one that is specifically designed for younger patients and delivers its content in various languages. However, this app isn’t covered by the patient’s insurance and it’s out of pocket expense is too much for the family to afford. Left without a timely and appropriate treatment option, the patient risks worsening symptoms and long-term implications if her struggle to find care persists. Even if solutions intended for children are built accordingly, they often have a difficult time succeeding on the market. Struggles like this suggest that commercial incentives for pediatric digital health solutions are misaligned. Payers are hesitant to reimburse products with limited real-world evidence, while clinicians and health systems are inundated with a plethora of solutions but feel underprepared to adopt them. Ultimately, children and their families are left with a murky picture of which digital health solutions are available to them and how to pay for them. Solving these challenges Digital solutions promise to solve some of the most challenging aspects of care delivery, increase access and improve quality of life. However, when encountered in real settings, these tools often fail to meet diverse patient needs, do not integrate easily into clinical workflows and struggle to define real-world benefits. Ultimately, this perpetuates a cycle of inequitable and fragmented solutions that have no clear path to commercial success. Delivering on the promise of digitization of pediatric care requires collaborative efforts between stakeholders, including clinicians, researchers, technology companies, investors, payers, policymakers and regulatory bodies. Ian is a program lead at the Digital Medicine Society, where he leads a multi-stakeholder effort to create The Playbook: Pediatric Digital Medicine, an open access, action-oriented resource intended to catalyze innovation in pediatric health care. He has a background in research, operations and strategy related to medical devices and mental health and is passionate about improving the lives of young people.