Mindera Health Receives New York State Approval for Mind.Px Psoriasis Precision Medicine Test
核心洞察
Mindera Health (搜索) received New York State Department of Health (搜索) approval for Mind.Px (搜索), a genomic test that predicts optimal biologic (搜索) therapy for psoriasis (搜索) patients using a proprietary dermal biomarker patch system.
The test demonstrates over 91% positive predictive value in matching patients to appropriate biologic (搜索) drug classes through machine learning-derived algorithms and transcriptomic analysis.
Mind.Px (搜索) is now available in all 50 states and offers potential annual cost savings of $5,138 to $13,141 per patient by optimizing treatment selection before therapy initiation.
Mindera Health (搜索) announced it has received approval from the New York State Department of Health (搜索) for its Mind.Px (搜索) test, a genomic precision medicine tool designed to predict optimal biologic (搜索) therapy for psoriasis (搜索) patients. The approval brings the company's precision medicine approach to all 50 states, marking a significant milestone in personalized dermatological care.
Revolutionary Dermal Biomarker Technology
Mind.Px (搜索) utilizes a proprietary dermal biomarker patch system to collect biomarkers from the skin in a minimally invasive manner. The collected samples undergo transcriptomic analysis combined with machine learning-derived algorithms to predict the most effective biologic (搜索) class for individual psoriasis (搜索) patients. This approach represents a departure from traditional trial-and-error prescribing methods.
The test demonstrates remarkable accuracy, with previously published studies showing that Mind.Px (搜索) predicts biologic (搜索) class with over 91% positive predictive value. This high level of precision enables healthcare providers to make more informed treatment decisions from the outset of therapy.
Regulatory Milestone and Quality Standards
The New York State Department of Health (搜索) approval required meeting the stringent quality standards established by New York's Clinical Laboratory Evaluation Program (CLEP), widely recognized as the highest quality benchmark for clinical laboratory and laboratory developed tests.
"We are extremely proud to have met the quality standards established by New York's Clinical Laboratory Evaluation Program (CLEP), a standard broadly seen as the highest quality benchmark for clinical laboratory and laboratory developed tests," said Tobin Dickerson, Chief Scientific Officer and Co-Founder of Mindera Health (搜索). "This certification demonstrates the scientific rigor of our laboratory team and our flagship test, Mind.Px (搜索), and we are eager to bring precision medicine to the psoriasis (搜索) patients of New York to help guide health care providers' biologic (搜索) selection."
Economic Impact and Cost Savings
The precision medicine approach offered by Mind.Px (搜索) extends beyond clinical benefits to significant economic advantages. A recent study utilizing a budget impact model predicted substantial cost savings associated with the test's implementation. The analysis revealed annual cost savings ranging from $5,138 to $13,141 per patient by matching patients to the appropriate drug class before treatment initiation.
These cost reductions stem from avoiding ineffective treatments and reducing the time to optimal therapy, minimizing both direct medical costs and indirect expenses associated with treatment failures.
Immediate Availability and Laboratory Infrastructure
Mind.Px (搜索) is now available immediately to New York patients, with Mindera Health (搜索) performing all tests in its CAP accredited, CLIA and ISO 13485:2016 certified facility located in Vista, California. The company operates as both a CLIA certified, CAP accredited laboratory and an ISO 13485:2016 certified manufacturer of the proprietary dermal biomarker patch device.
The test process involves rapid and painless extraction of mRNA (搜索) from skin using the dermal biomarker patch, followed by next-generation sequencing and machine learning analysis to generate clinically actionable results for healthcare providers.
Advancing Precision Medicine in Dermatology
Mindera Health (搜索) positions itself as a leader in precision medicine for dermatological conditions, developing next-generation medical technology to enable molecular-level skin analytics. The company's approach combines proprietary dermal biomarker patches, next-generation sequencing, and machine learning to create clinically validated solutions designed to improve patient outcomes while reducing healthcare system costs.
The New York approval represents a significant expansion of access to precision medicine tools for psoriasis (搜索) management, potentially transforming how dermatologists approach biologic (搜索) therapy selection across the United States.