CLIA

Inocras Inc. Unveils Rebranding of Genome Insight

Retrieved on: 
Monday, March 18, 2024
Technology, Neurology, Genetics, Biotechnology, Other Health, Health, Data Management, Artificial Intelligence, Oncology, Disease, Patient, Research, Cancer, AI, CAP, CLIA, Whole genome sequencing, Nursing care plan, Antibiotics

Inocras, formerly known as Genome Insight, announced today its rebranding initiative to reflect its commitment to innovation and user-centric healthcare solutions.

Key Points: 
  • Inocras, formerly known as Genome Insight, announced today its rebranding initiative to reflect its commitment to innovation and user-centric healthcare solutions.
  • The AI-driven whole genome platform company, specialized in whole genome sequencing and analytics for cancer and rare diseases, has embarked on its rebranding to reinforce its dedication to shaping an "innovative tomorrow".
  • The rebranding accentuates its focus on "user-centric approaches" for patients, providers, and researchers, surpassing the provision of sequencing and analytics services.
  • Inocras Inc. (formerly Genome Insight Inc.) is a pioneering provider of whole genome sequencing and analytics services for cancer and rare diseases.

New Research Shows the PrecivityAD2™ Blood Test Has High Accuracy Compared to Amyloid PET Scans in Individuals with Cognitive Impairment

Retrieved on: 
Monday, March 18, 2024
Mental Health, Managed Care, Medical Devices, Hospitals, Neurology, Science, Medical Supplies, Clinical Trials, Biotechnology, Health, Health Technology, Health Insurance, Other Science, Research, Radiology, Pharmaceutical, Seniors, Radiation, APS2, Certification, Brain, Alzheimer's disease, Deficit spending, Disease, Memory, AUC, Patient, Ageing, PET, Journal, Apolipoprotein, City, CLIA, Pathology, Medicare, Amyloid, Medical imaging

The AUC-ROC for the PrecivityAD2 test output, the Amyloid Probability Score 2 (APS2), was 0.94, yielding 88% agreement with brain amyloid status based on a single cut-off value.

Key Points: 
  • The AUC-ROC for the PrecivityAD2 test output, the Amyloid Probability Score 2 (APS2), was 0.94, yielding 88% agreement with brain amyloid status based on a single cut-off value.
  • The APS2 result was the most robust method among the individual plasma amyloid and tau analytes measured to identify disease.
  • In the published study, the PrecivityAD2 blood test was clinically validated in 583 individuals with cognitive impairment across two independent cohorts.
  • C₂N is working toward obtaining the requisite certification that will permit the PrecivityAD2 test to be available in New York in the near future.

The Association for Diagnostics & Laboratory Medicine (formerly AACC) recommends to Congress that the regulation and modernization of clinical tests be managed under the auspices of the Clinical Laboratory Improvement Advisory Committee, CMS, and Congress

Retrieved on: 
Tuesday, April 2, 2024
American Medical Association, Education, Congress, Labour, Ranking, Committee, AACC, Communication, Diagnosis, Children's Hospital Association, CLIA, Clinical Laboratory, Medical laboratory, Medicare, FDA, CMS, Health, Food, Medical device

Specifically, ADLM supports modernizing the Clinical Laboratory Improvement Amendments (CLIA), through which the Centers for Medicare & Medicaid Services (CMS) regulates laboratory developed tests.

Key Points: 
  • Specifically, ADLM supports modernizing the Clinical Laboratory Improvement Amendments (CLIA), through which the Centers for Medicare & Medicaid Services (CMS) regulates laboratory developed tests.
  • Additional FDA oversight would be duplicative, costly — and could force many clinical labs to stop performing these essential tests.
  • "As an alternative, ADLM suggests updating CLIA's standards through the Clinical Laboratory Improvement Advisory Committee (CLIAC).
  • "Once changes are made through the regulatory process, ADLM proposes that Congress evaluate and update the underlying statute that governs CLIA.

Nucleus Genomics launches to bring whole-genome sequencing to the public

Retrieved on: 
Monday, March 25, 2024
Human Genome Project, WGS, Blood pressure, Genomics, Health, Certification, Informatics, Founders Fund, Genetic testing, Risk, Genetics, Human, PRS, DNA, Accreditation, Breast, CAP, Overalls, Facial muscles, Cancer, CLIA, Breast cancer, BRCA2, BMI, BRCA1

NEW YORK, March 25, 2024 /PRNewswire/ -- Nucleus Genomics, the next-generation genetic testing and analysis company, today announced the launch of its DNA analysis product to bring the benefits of personalized medicine to everyone.

Key Points: 
  • Nucleus further personalizes these risk assessments by integrating personal and lifestyle factors into their analysis — such as age, cholesterol levels, blood pressure, and BMI.
  • Nucleus will also offer pre-orders for its premium clinical-grade whole-genome sequencing (WGS) service, in which a customer's entire set of DNA will be read and analyzed.
  • Nucleus is proud to sequence all customer samples in the U.S. on Illumina's NovaSeq X Plus, the sequencing company's newest and most innovative high-throughput sequencing instrument.
  • Working with Illumina, Nucleus is leveraging this latest sequencing technology to make WGS broadly accessible to power personalized healthcare.

The Global Parkinson's Genetics Program and Psomagen Inc. Make Agreement with Goal to Transform Parkinson's Disease Genetics Research and Patient Outcomes

Retrieved on: 
Monday, March 18, 2024
WGS, Organization, ASAP, Parkinson's disease, Coalition, Disease, KOSDAQ, PD, Genetics, Patient, Research, MJFF, Science, CAP, Doctor of Philosophy, Laboratory, CLIA, Whole genome sequencing, Bangladesh Technical Education Board, ISO

The program will run over the next 2.5 - 3 years using Illumina sequencing instruments and reagents.

Key Points: 
  • The program will run over the next 2.5 - 3 years using Illumina sequencing instruments and reagents.
  • GP2 is a program supported by the Aligning Science Across Parkinson's (ASAP) initiative managed by the Coalition for Aligning Science and implemented by The Michael J.
  • Fox Foundation for Parkinson's Research (MJFF) and is focused on improving our understanding of the genetic architecture of Parkinson's disease and making this knowledge globally relevant.
  • GP2 specifically has the goal of including groups traditionally underrepresented in genetics research, to diversify its understanding of PD by focusing on inclusion in the research pipeline.

Exact Sciences Launches Riskguard™ Hereditary Cancer Test in the United States

Retrieved on: 
Wednesday, February 28, 2024
Biotechnology, Health, Biometrics, Other Health, Pharmaceutical, Oncology, Practice Management, Medical Devices, General Health, Hospitals, Genetics, Health Technology, Health Insurance, Medical Supplies, Breast cancer, College, NCI, Multimedia, Physician, Cancer, Food, Prostate, Skin, National Cancer Institute, Risk, Breast, Medicine, CGC, Medicare, Patient, Genetic testing, CLIA, Gene, Kidney, CAP, Exact sciences, Insurance

Exact Sciences Corp., a leading provider of cancer screening and diagnostic tests, today announced the launch of the Riskguard™ hereditary cancer test in the United States.

Key Points: 
  • Exact Sciences Corp., a leading provider of cancer screening and diagnostic tests, today announced the launch of the Riskguard™ hereditary cancer test in the United States.
  • Offering more effective personalized screening solutions supports Exact Sciences’ commitment to help detect cancer earlier.”
    For patients already diagnosed with cancer, knowing about certain gene variants can help create individualized treatment plans for patients.
  • Exact Sciences’ customer care teams are available to help patients explore the testing process and understand possible results and outcomes.
  • The test is processed in Marshfield, WI at PreventionGenetics, an Exact Sciences laboratory qualified to perform high-complexity clinical laboratory testing that has been providing quality genetic testing since 2004 and joined Exact Sciences in 2022.

Veracyte to Participate in the Raymond James 45th Annual Institutional Investors Conference

Retrieved on: 
Wednesday, February 21, 2024
Software, Research, Professional Services, Oncology, Technology, Artificial Intelligence, Genetics, Health Technology, Data Analytics, Science, Biotechnology, Health, Doctor of Philosophy, Webcast, CLIA, Conference

Veracyte, Inc .

Key Points: 
  • Veracyte, Inc .
  • (Nasdaq: VCYT) announced today that Marc Stapley, chief executive officer, and John Leite, Ph.D., chief commercial officer, CLIA, will present at the Raymond James 45th Annual Institutional Investors Conference on Monday, March 4, 2024, at 9:50 a.m. Eastern Time.
  • A live audio webcast of the company’s presentation will be available by visiting Veracyte’s website at http://investor.veracyte.com/events-presentations .
  • A replay of the webcast will be available for 90 days following the conclusion of the live broadcast.

Dr. Ernst J. Schaefer, MD, joins Olaris Inc. as CLIA Laboratory Director

Retrieved on: 
Tuesday, March 5, 2024
Human nutrition, Bangladesh Technical Education Board, Ageing, Research, American Heart Association, Cardiovascular disease, Metabolomics, Health, Tufts University, Society, University, Health care, Medicine, Fluid mechanics, Policy, CLIA, Patient, Machine learning, Nutrition, Publication, Tufts Medical Center, Medical device

FRAMINGHAM, Mass., March 5, 2024 /PRNewswire-PRWeb/ -- Olaris, Inc., a precision medicine company leveraging metabolomics and machine learning for the discovery and development of its myOLARIS™ diagnostics products, announced that Dr. Ernst Schaefer, a 30-year veteran in clinical diagnostics and an expert in developing monitoring tools to improve human health will be joining as CLIA Laboratory Director. Dr. Schaefer will continue in his role as laboratory director for Boston Heart Diagnostics, a company he co-founded in 2007, and at Clinical Enterprise, both in Framingham, MA.

Key Points: 
  • Olaris, Inc. a developer of metabolomic based precision diagnostics is pleased to announce that Dr. Ernst Schaefer, a 30 year veteran in clinical diagnostics and an expert in developing monitoring tools to improve human health will be joining as CLIA Laboratory Director.
  • Dr. Schaefer will continue in his role as laboratory director for Boston Heart Diagnostics, a company he co-founded in 2007, and at Clinical Enterprise, both in Framingham, MA.
  • "Ernie has one of the top clinical diagnostic minds in the world" said Dr. Elizabeth O'Day, CEO and Founder of Olaris.
  • I can't think of a better partner to bring Olaris' innovative diagnostics to the patients that need them".

Genetic Health Service Provider, Panacea, Launches to Make Whole Exome Sequencing Accessible to Consumers Without Insurance Barriers

Retrieved on: 
Wednesday, February 28, 2024
PALM, Breast cancer, Dahlia, Sequence, BRCA, Risk, Health, Ovarian cancer, CLIA, Ashkenazi Jews, Exome sequencing, Disease, Science, Mutation, CAP, Insurance, Cancer, Vaccine

PALM BEACH, Fla., Feb. 28, 2024 /PRNewswire/ -- Panacea, the one-stop-shop for genetic health services making potentially life-saving testing accessible for consumers, today announced its nationwide* commercial availability, without needing to visit a doctor or receive approval from insurance.

Key Points: 
  • The problem is that current guidelines for doctors to order genetic tests, and for insurance to approve it, are missing about half of the people with genetic mutations.
  • "I had my exome sequenced with Panacea, even though I was not a candidate for testing based on today's medical guidelines.
  • This further inspired me to make clinical-grade whole exome sequencing more accessible, so everyone can make informed decisions about their future."
  • For more information on Panacea or on whole exome sequencing, please visit seekpanacea.com .

Record-making Partnerships: IntraCare Continues to Strengthen Presence in Arizona as Three More Clinics Sign on in December

Retrieved on: 
Friday, February 16, 2024
Award, Physician, News, Growth, FAAFP, American Medical Association, Family, Partner, COVID-19, MSO, Patient, CLIA, Medicine, State, Commission, Partnership, Nursing

CARROLLTON, Texas, Feb. 16, 2024 /PRNewswire/ -- IntraCare, a prominent Texas-based MSO, gained record growth in the month of December 2023 upon signing partnership agreements with three medical entities in Arizona. This adds another 16 care practitioners to IntraCare's provider network.

Key Points: 
  • As a result of this expansion, IntraCare is better positioned to meet the requirements of a continually evolving healthcare industry, across diverse communities.
  • Partner practices will benefit from a significant increase in service outreach and more senior patients will gain access to value-based care.
  • The centralization of administrative and management functions will standardize care management delivery across the three new clinics, bringing them on par with the IntraCare network of health centers.
  • "I am immensely grateful to our partners for the trust they have placed in IntraCare," said Anwar Kazi, Chief Executive Officer of IntraCare.