🔍 Navigating the New FDA-LDT Rule: Winners and Losers in Diagnostic Laboratory Testing 🥇🥉 📖As the FDA introduces stricter regulations for Laboratory Developed Tests (LDTs), the implications for established and emerging diagnostic laboratories are starkly different. 🏆 Strategic Advantages for Established Labs: 📌 Grandfathering Provision & NYS CLEP carve out: The FDA’s grandfathering clause allows on market LDTs and those approved by NYS CLEP to operate under enforcement discretion. This distinctly benefits established labs that have a broad portfolio of on market tests, providing them stability and continuity that new labs lack. Myriad Genetics' latest earnings call, featuring insights from COO Sam Raha reveals how established laboratories may emerge as winners: https://lnkd.in/daMqhZGS 📢Favorable Regulation: "Our current view is that this finalized version of the rule is more favorable than the preliminary guidance," notes Raha. 📢Compliance and Experience: "All of our on-market tests meet CAP/CLIA, New York State requirements...we have a strong quality assurance regulatory affairs organization," Raha adds, highlighting Myriad's preparedness and long-standing FDA collaboration. 📈 Strategic Insight: The regulatory shift is likely to create a bifurcated market where established diagnostic laboratories can capitalize on their entrenched positions and regulatory expertise. 👉Established laboratories are likely to face fewer disruptions compared to startups, which must navigate complex regulatory frameworks from scratch. 👉Established laboratories generally have more extensive resources and infrastructure to manage regulatory changes, which can be a significant hurdle for startups with limited capital and smaller teams. 🤔 How will this affect innovation in the diagnostics industry?… #Diagnostics #FDALDTRule #BusinessStrategy
Maximilian Schmid, M.D.’s Post
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Interesting to see the more established companies embracing these new regulations. This should be a red flag to outside consumers who want the best products at the lowest price. These companies know that the regulation will prevent new competition, while they will be able to adapt. The products wont change and costs will increase.
🔍 Navigating the New FDA-LDT Rule: Winners and Losers in Diagnostic Laboratory Testing 🥇🥉 📖As the FDA introduces stricter regulations for Laboratory Developed Tests (LDTs), the implications for established and emerging diagnostic laboratories are starkly different. 🏆 Strategic Advantages for Established Labs: 📌 Grandfathering Provision & NYS CLEP carve out: The FDA’s grandfathering clause allows on market LDTs and those approved by NYS CLEP to operate under enforcement discretion. This distinctly benefits established labs that have a broad portfolio of on market tests, providing them stability and continuity that new labs lack. Myriad Genetics' latest earnings call, featuring insights from COO Sam Raha reveals how established laboratories may emerge as winners: https://lnkd.in/daMqhZGS 📢Favorable Regulation: "Our current view is that this finalized version of the rule is more favorable than the preliminary guidance," notes Raha. 📢Compliance and Experience: "All of our on-market tests meet CAP/CLIA, New York State requirements...we have a strong quality assurance regulatory affairs organization," Raha adds, highlighting Myriad's preparedness and long-standing FDA collaboration. 📈 Strategic Insight: The regulatory shift is likely to create a bifurcated market where established diagnostic laboratories can capitalize on their entrenched positions and regulatory expertise. 👉Established laboratories are likely to face fewer disruptions compared to startups, which must navigate complex regulatory frameworks from scratch. 👉Established laboratories generally have more extensive resources and infrastructure to manage regulatory changes, which can be a significant hurdle for startups with limited capital and smaller teams. 🤔 How will this affect innovation in the diagnostics industry?… #Diagnostics #FDALDTRule #BusinessStrategy
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🔍 Attention Investors! As market dynamics shift, staying informed is your best strategy. Faruqi & Faruqi, LLP is investigating potential claims against Applied Therapeutics, reminding us all to balance optimism with caution. Equip yourself with insights and consult with experts to navigate these waters wisely. Stay engaged and proactive for best investment practices! #InvestmentAwareness #RiskManagement #InvestorEducation #InvestmentInsights #MarketTrends #DueDiligence #FinancialLitigation #AppliedTherapeutics #ProactiveInvesting
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BioPharma & HealthTech Competitive Strategy & Insights | Digital & AI Solutions | Gene & Cell Therapy | Vaccines
Thoughts on this? >> Longevity investors look to add $200M to the table with new growth fund >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #healthcare #productmarketing #pharmaceutical #biotech
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What are the Strengths, Weaknesses, Opportunities and Threats of Entrada Therapeutics, Inc. (TRDA)? SWOT Analysis Main parts of the financial model: * Dashboard, * Income Statement, * Cash Flow, * Balance Sheet, * WACC calculation, * DCF calculation, * Liquidity / Profitability / Cash Flow / Debt Ratios https://lnkd.in/d_GQKVEy
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Thoughts on this? >> Longevity investors look to add $200M to the table with new growth fund >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #biotech #productmarketing #pharmaceutical #healthcare
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Our goal is to help our clients make the most informed decisions at each step and provide them with a whole new level of clarity and control. We have deep experience working with clients in the biotech, pharma, and life sciences sectors, and we understand the unique patterns and paths of each. With our in-depth understanding of often complex company benefits, we help our clients make the most informed decisions each step of the way. Explore how we can help you streamline your finances: https://lnkd.in/esehZbAb #LRVS #LRVSAdvisory #BostonMA #WealthManagement #InvestmentManagement #WealthAdvisors #FinancialPlanning #RetirementPlanning #CompanyBenefitsPlanning #YourFamilyCFO
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Have you seen this recent article by The Australian Financial Review which talks about the biotech boom? Read the full article below ⬇ #ASX #AGN #biotech #AFR
Great article in the AFR, biotech is booming! Argenica Therapeutics is one to watch https://lnkd.in/e7nbHiHu
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Founder of ClinBAY, a global biometrics CRO. Engaged in the development and adoption of innovative artificial intelligence solutions to advance healthcare.
ClinBAY also supports #VentureCapital biotech funds. Do you know why? #VC firms often invest in early-stage, high-growth, and high-risk companies. When it comes to making investment decisions, three key criteria come into play: the #asset, the #team, and the #data: - The asset involves selecting the right molecules, evaluating their targets, modes of action, and impact on diseases. - VCs also need confidence in the management team’s ability to successfully develop the asset on time and within budget. - Finally, the quality of data generated by the team is critical—it will ultimately drive return on investment. A successful Phase II trial, for instance, could lead to an acquisition by a major pharma company. As a #biometrics #CRO, ClinBAY plays a pivotal role in helping VCs de-risk their investments. How? Our #team consists of true experts in generating high-quality clinical data. We optimize clinical development plans, ensuring studies have the right design, goals, and sample sizes. We also assist our VC clients in monitoring their portfolio companies. Is the data package reliable enough? What’s the next best decision? How can we unlock a clinical development issue? These are questions we help answer. When you consider the vast sums of money VCs invest, it certainly makes sense to seek qualified statistical and data advice to maximize returns. Have you had similar experiences? Feel free to share in the comments!
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What are the Strengths, Weaknesses, Opportunities and Threats of TG Therapeutics, Inc. (TGTX)? SWOT Analysis Main parts of the financial model: * Dashboard, * Income Statement, * Cash Flow, * Balance Sheet, * WACC calculation, * DCF calculation, * Liquidity / Profitability / Cash Flow / Debt Ratios https://lnkd.in/e3p3vqij
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