NYSDOH

Therap Interfaces with a new Electronic Visit Verification (EVV) Aggregator to Assist Service Providers in New York

Retrieved on: 
Thursday, January 25, 2024

This development expands the array of EVV services exchanged under New York State Medicaid, allowing service providers to utilize Therap Services for additional codes in personal care and consumer directed services.

Key Points: 
  • This development expands the array of EVV services exchanged under New York State Medicaid, allowing service providers to utilize Therap Services for additional codes in personal care and consumer directed services.
  • Therap's integration effectively manages and oversees the State's Electronic Visit Verification (EVV) data, ensuring compliance with the 21st Century Cures Act.
  • Utilizing GPS-enabled mobile applications, Therap's EVV system offers a comprehensive solution designed to enable service providers to document data from the point of service.
  • Therap's EVV tools provide a comprehensive solution designed to enable service providers to document data from the point of service.

PreciseDx's "Analytical Validation of a Digital Breast Cancer Test Predicting Recurrence in Early-Stage Breast Cancer" Featured in Clinical Breast Cancer

Retrieved on: 
Tuesday, November 7, 2023

NEW YORK, Nov. 7, 2023 /PRNewswire/ -- PreciseDx®, a leading innovator in oncology diagnostics, leveraging Artificial Intelligence (AI) for revolutionary, morphology-driven, disease analysis, today announced that its analytical validation study for its PreciseBreast™ assessment has been published in the November 3, 2023 issue of Clinical Breast Cancer.

Key Points: 
  • Collectively, these studies demonstrated an analytical performance that accurately predicts early-stage breast cancer risk of recurrence within 6 years.
  • PreciseBreast™ is an in vitro prognostic test that predicts breast cancer recurrence for patients diagnosed with early-stage IBC.
  • This latest study builds upon PreciseDx's earlier clinical validation study published in Breast Cancer Research (cited 2022 Dec 21, 24:93.
  • "Our innovative digital assessment holds immense promise in enhancing early-stage breast cancer recurrence prediction, ultimately improving patient care and outcomes.

New York State Laboratory Approved for Genetic Testing Using Saliva

Retrieved on: 
Tuesday, October 17, 2023

SYRACUSE, N.Y., Oct. 17, 2023 /PRNewswire/ -- Quadrant Laboratories announced today that its Syracuse-based lab has been approved by the New York State Department of Health for genetic testing. This is in conjunction with the NYSDOH approval of Quadrant's Fragile X Syndrome (FXS) test, which is now available for physicians to order in all 50 states. Quadrant's FXS test uses a saliva swab as a primary collection, rather than a blood draw, and can be collected in the patient's home before getting shipped back to be tested in Quadrant's CLIA/CLEP certified clinical lab.

Key Points: 
  • SYRACUSE, N.Y., Oct. 17, 2023 /PRNewswire/ -- Quadrant Laboratories announced today that its Syracuse-based lab has been approved by the New York State Department of Health for genetic testing.
  • Dr. Funda Suer, EVP of Clinical Diagnostics and Clinical Laboratory Director for Quadrant Laboratories, said, "In both the pediatric and adolescent populations, we found it was much easier to collect saliva versus blood.
  • This genetic condition  is caused by changes in the FMR1 gene, which is responsible for creating a protein crucial in brain development.
  • Following the discovery of the association between the FMR1 gene and FXS, gene-specific testing has made identifying the condition significantly more accurate.

New York State Approves Pathnostics' Guidance UTI Test

Retrieved on: 
Wednesday, October 4, 2023

IRVINE, Calif., Oct. 4, 2023 /PRNewswire/ -- Pathnostics, a leading precision diagnostic testing and development company, today announced that its advanced test for urinary tract infections (UTIs) has gained approval from the New York State Department of Health (NYSDOH). The approval broadens patient access to the company's Guidance® UTI test, which enables rapid diagnosis and precise treatment of complicated, recurrent, and persistent UTIs.

Key Points: 
  • The approval broadens patient access to the company's Guidance® UTI test, which enables rapid diagnosis and precise treatment of complicated, recurrent, and persistent UTIs.
  • To learn more about Pathnostics' Guidance UTI test, click here .
  • "We are thrilled that our Guidance UTI test has been approved by an organization renowned for its expertise, high standards, and stringent process for validating clinical lab tests.
  • Earning this approval is a testament to the Guidance UTI test and its impact in addressing a complex health challenge."

GUTHRIE CORNING HOSPITAL NAMED PROVISIONAL LEVEL III TRAUMA CENTER

Retrieved on: 
Tuesday, August 29, 2023

Corning, N.Y., Aug. 29, 2023 (GLOBE NEWSWIRE) -- Officials at The Guthrie Clinic announced today that Guthrie Corning Hospital has been designated a Provisional Level III Adult Trauma Center by the New York State Department of Health (NYSDOH), effective August 28, 2023.

Key Points: 
  • Corning, N.Y., Aug. 29, 2023 (GLOBE NEWSWIRE) -- Officials at The Guthrie Clinic announced today that Guthrie Corning Hospital has been designated a Provisional Level III Adult Trauma Center by the New York State Department of Health (NYSDOH), effective August 28, 2023.
  • “Guthrie Corning Hospital now joins Guthrie Robert Packer Hospital and Guthrie Troy Community Hospital as designated/accredited trauma centers,” said Dr. Edmund Sabanegh, President and CEO of The Guthrie Clinic.
  • A Level III Trauma Center increases the level of care available to those facing medical emergencies and provides critical support in emergency situations.
  • Guthrie’s Robert Packer Hospital is an accredited Level I Trauma Center and Guthrie Troy Community Hospital is an accredited Level IV Trauma Center by the Pennsylvania Trauma Systems Foundation.

New York State Department of Health Approves PathoZoom Rapid On Site Evaluation in Fine Needle Aspirates Specimens LDT

Retrieved on: 
Thursday, May 4, 2023

The New York State Department of Health has approved Cayuga Health System to use a Smart In Media PathoZoom LiveView laboratory developed test (LDT) image-based method for digital slide sharing - Rapid On Site Evaluation (ROSE) in fine needle aspirates specimens, the company said on Tuesday.

Key Points: 
  • The New York State Department of Health has approved Cayuga Health System to use a Smart In Media PathoZoom LiveView laboratory developed test (LDT) image-based method for digital slide sharing - Rapid On Site Evaluation (ROSE) in fine needle aspirates specimens, the company said on Tuesday.
  • With the approval, Cayuga can begin testing patient samples using its PathoZoom system in the state of New York through its CLIA-certified laboratory.
  • The Clinical Laboratory Evaluation Program (CLEP) used to validate the assay is among the most important and rigorous levels of validation for LDTs, Smart In Media noted.
  • Each LDT submitted to the NYSDOH must undergo review for analytical and clinical performance, as well as reproducibility.

Applied DNA Submits Validation Package to New York State Department of Health for Approval of Pharmacogenomic (PGx) Assay

Retrieved on: 
Wednesday, March 22, 2023

Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in PCR-based DNA technologies, today announced that its wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC (ADCL), has submitted a validation package to the New York State Department of Health (NYSDOH) in support of approval for a pharmacogenomics (PGx) assay as a NYSDOH laboratory-developed test (LDT).

Key Points: 
  • Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in PCR-based DNA technologies, today announced that its wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC (ADCL), has submitted a validation package to the New York State Department of Health (NYSDOH) in support of approval for a pharmacogenomics (PGx) assay as a NYSDOH laboratory-developed test (LDT).
  • If approved by NYSDOH, the LDT test will be used by ADCL to power its population-scale PGx testing services.
  • ADCL’s PGx testing will focus on population-scale testing that is expected to be accretive to ADCL’s margin profile.
  • ADCL’s commercial strategy is centered on the direct-to-enterprise and self-insured health markets that do not require ADCL to seek third-party reimbursement or engage in individual patient billing.

PreciseDx Receives New York State Approval for an AI-Enabled Breast Diagnostic

Retrieved on: 
Tuesday, February 7, 2023

NEW YORK, Feb. 7, 2023 /PRNewswire/ -- PreciseDx, a leading innovator in AI-powered, patient-specific disease analysis, today announced that the New York State Department of Health (NYSDOH) has approved the PDxBr, a Lab Developed Test (LDT) designed to enrich breast cancer grading and improve risk categorization. With this approval, PreciseDx can now begin commercially testing patient samples in the state of New York through its CLIA certified laboratory.

Key Points: 
  • With this approval, PreciseDx can now begin commercially testing patient samples in the state of New York through its CLIA certified laboratory.
  • "We are pleased to receive the approval from the New York State Department of Health for our PDxBr breast test.
  • The study detailed that the PDxBr breast test enriches breast cancer grading and improves risk categorization.
  • "Now, with the recent approval from the New York State Department of Health, the testing platform will soon be available to providers and patients throughout the state."

Applied DNA Announces Receipt of Largest Single Purchase Order for LinearDNA™ To-Date

Retrieved on: 
Monday, October 10, 2022

Applied DNA Sciences, Inc. (NASDAQ: APDN) (the Company), a leader in PCR-based DNA technologies, announced today that it received its largest single purchase order for LinearDNA valued above the mid-six-figures.

Key Points: 
  • Applied DNA Sciences, Inc. (NASDAQ: APDN) (the Company), a leader in PCR-based DNA technologies, announced today that it received its largest single purchase order for LinearDNA valued above the mid-six-figures.
  • LinearDNA is produced using an enzymatic (cell-free) manufacturing platform that eliminates the use of fermenters and bacteria required by plasmid DNA, the industrys current manufacturing standard for DNA.
  • LinearDNA eliminates many of the challenges associated with current plasmid-based DNA manufacturing and produces a DNA product without the risks of bacterial contamination and non-target DNA sequences.
  • Applied DNA Sciences is a biotechnology company developing technologies to produce and detect deoxyribonucleic acid (DNA).

Applied DNA Launches Monkeypox Testing Service

Retrieved on: 
Tuesday, September 6, 2022

Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the Company), a leader in PCR-based DNA technologies, announced today that its wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC (ADCL), has launched monkeypox testing as a clinical reference laboratory testing service available to hospital systems and clinical labs located in New York State and in states that recognize New York's CLEP/CLIA certification for testing.

Key Points: 
  • Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the Company), a leader in PCR-based DNA technologies, announced today that its wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC (ADCL), has launched monkeypox testing as a clinical reference laboratory testing service available to hospital systems and clinical labs located in New York State and in states that recognize New York's CLEP/CLIA certification for testing.
  • Having built ADCLs stellar reputation for high-capacity, PCR-based COVID-19 testing with rapid TAT, we believe we can bring to bear the same expertise to the monkeypox public health emergency, stated Dr. James A. Hayward, president and CEO of Applied DNA Sciences.
  • ADCLs monkeypox test utilizes an A17L gene-target specific to monkeypox virus Clade II that enables the qualitative detection and differentiation of the monkeypox virus from other non-variola orthopoxviruses using real-time PCR.
  • To learn more about ADCLs monkeypox testing service, click to: adnas.com/monkeypox-testing
    Applied DNA Sciences is a biotechnology company developing technologies to produce and detect deoxyribonucleic acid (DNA).