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Certified Laboratory Articles & Analysis

23 news found

SOPHiA Genetics Announces Validation of Novel Clinical Trial Assay Together with Precision for Medicine at World Clinical Biomarkers & CDx 2024

SOPHiA Genetics Announces Validation of Novel Clinical Trial Assay Together with Precision for Medicine at World Clinical Biomarkers & CDx 2024

The two companies collaborated with precision medicine clinical research organization (CRO) Precision for Medicine, which contributes its state-of-the-art, CAP-accredited, CLIA-certified laboratory services to Boundless Bio’s POTENTIATE Phase 1/2 clinical trial by successfully validating a proprietary workflow to process patient samples. ...

BySOPHiA Genetics


NeuroPointDX to Present Precision Medicine Approaches to Diagnosing and Treating Autism at National TACA Autism Conference

NeuroPointDX to Present Precision Medicine Approaches to Diagnosing and Treating Autism at National TACA Autism Conference

” Based on the initial published CAMP data and other subsequent findings, NeuroPointDX began a limited launch at the end of 2018 of its NPDX ASD test, a blood test provided through NeuroPointDX’s CLIA-certified laboratory. The test identifies metabolic subtypes affecting about 30% of children with ASD, and for a subset of these children, may help ...

ByNeuroPointDX


InMed Launches THCV, Expanding its Portfolio of Rare Cannabinoids for the Health and Wellness Sector

InMed Launches THCV, Expanding its Portfolio of Rare Cannabinoids for the Health and Wellness Sector

BayMedica’s cannabinoids are made in accordance with food-grade GMP standards and are rigorously tested at certified laboratories. Like all BayMedica minor cannabinoid products, d9-THCV can be combined in precise ratios with other cannabinoids to create unique health and wellness products. ...

ByInMed Pharmaceuticals Inc.


PAVmed PAVmed Provides Business Update and Preliminary First Quarter 2022 Financial Results

PAVmed PAVmed Provides Business Update and Preliminary First Quarter 2022 Financial Results

(“LucidDx Labs”), a wholly owned subsidiary of Lucid, acquired the assets necessary to operate its own CLIA-certified, CAP-accredited clinical laboratory and hired an experienced VP of Laboratory Operations. ...

ByPAVmed Inc.


Lucid Diagnostics Provides Business Update and Preliminary First Quarter 2022 Financial Results

Lucid Diagnostics Provides Business Update and Preliminary First Quarter 2022 Financial Results

“Our team continues to drive EsoGuard® commercialization, expand our sales infrastructure, execute the second stage of our Lucid Test Center rollout, transition to our own fully staffed laboratory, and work tirelessly to secure EsoGuard reimbursement. Our balance sheet remains strong, providing us with the necessary resources to execute this ...

ByPAVmed Inc.


Lucid Diagnostics’ Laboratory Executes Participating Provider Agreement with MediNcrease Health Plans

Lucid Diagnostics’ Laboratory Executes Participating Provider Agreement with MediNcrease Health Plans

(Nasdaq: PAVM, PAVMZ) (“PAVmed”), today announced that its wholly-owned CLIA-certified and CAP-accredited laboratory, LucidDx Labs Inc. (“LucidDx Labs”), has entered into a participating provider agreement with MediNcrease Health Plans, LLC (“MediNcrease”), a national, directly-contracted, multi-specialty PPO provider network ...

ByPAVmed Inc.


Deep Lens and Southern Oncology Specialists Enter Strategic Partnership

Deep Lens and Southern Oncology Specialists Enter Strategic Partnership

The practice offers complete oncology and hematology care with onsite imaging, high complex CLIA certified laboratory, retail specialty pharmacy and state-of-the-art infusion services. Southern Oncology Specialists’ board-certified providers offer personalized, compassionate care for each patient, in a comfortable and convenient setting. ...

ByDeep Lens Inc.


GRAIL Receives New York State Approval for Galleri Multi-Cancer Early Detection Blood Test

GRAIL Receives New York State Approval for Galleri Multi-Cancer Early Detection Blood Test

The standard set by New York State represents one of the most rigorous levels of validation required for laboratory developed tests. Clinical laboratories conducting testing on specimens from New York residents also must obtain a clinical laboratory permit. ...

ByGrail, Inc.


Kephera Diagnostics launches CLIA test for quantitative antibody response to COVID-19 vaccination

Kephera Diagnostics launches CLIA test for quantitative antibody response to COVID-19 vaccination

The test will be available as a service through Kephera’s CLIA-certified laboratory. Kephera’s COVI-QUANT™ test measures the level of IgG antibodies to the spike protein, a viral component which is the key antigen in current COVID-19 vaccines. ...

ByKephera Diagnostics, LLC


FDA Authorizes New High-Throughput, Automated System for Leading COVID-19 Test

FDA Authorizes New High-Throughput, Automated System for Leading COVID-19 Test

Amplitude Solution with TaqPath COVID-19 High-Throughput Combo Kit enables labs to scale high-sensitivity PCR testing The Amplitude Solution enables clinical and public health laboratories to scale gold standard PCR testing and process up to 8,000 samples in a single day with minimal staffing resources and a secured supply of kits, reagents and consumables to meet their testing ...

ByThermo Fisher Scientific, LIMS & Laboratory Software


Bio-Techne Announces ExoTRU Kidney Transplant Rejection Assay Data Publication

Bio-Techne Announces ExoTRU Kidney Transplant Rejection Assay Data Publication

ExoTRU was developed in collaboration with the Azzi laboratory at the Transplantation Research Center at Brigham and Women’s Hospital, Harvard Medical School. ...

ByExosome Diagnostics, Inc.


FDA Grants Emergency Use Authorization for New COVID-19, Flu A, Flu B Combo Kit

FDA Grants Emergency Use Authorization for New COVID-19, Flu A, Flu B Combo Kit

"This new kit offers clinical and public health laboratories a single test to help diagnose and monitor the spread of COVID-19 and the flu." ...

ByThermo Fisher Scientific, LIMS & Laboratory Software


Unique Metabolic Signatures Associated with Autism Spectrum Disorder (ASD) Detect More than 50% of individuals with ASD in Children’s Autism Metabolome Project (CAMP)

Unique Metabolic Signatures Associated with Autism Spectrum Disorder (ASD) Detect More than 50% of individuals with ASD in Children’s Autism Metabolome Project (CAMP)

NeuroPointDX has developed and is commercializing testing panels to aid in the early diagnosis of ASD through its CLIA-certified ...

ByNeuroPointDX


Thermo Fisher Scientific Increases Availability of COVID-19 Testing with Sample Collection Kit from Everlywell

Thermo Fisher Scientific Increases Availability of COVID-19 Testing with Sample Collection Kit from Everlywell

Samples collected using the Everlywell self-collection kit may be processed by CLIA-certified laboratories running Thermo Fisher's TaqMan SARS-CoV-2 RNase P Assay Kit, and the results obtained through the Everlywell online platform. ...

ByThermo Fisher Scientific, LIMS & Laboratory Software


OPTI Medical Systems Receives CE Mark for Its OPTI SARS-CoV-2 RNA PCR Test Kit for Detection of the Virus Causing COVID-19

OPTI Medical Systems Receives CE Mark for Its OPTI SARS-CoV-2 RNA PCR Test Kit for Detection of the Virus Causing COVID-19

OPTI Medical Systems, Inc., a subsidiary of IDEXX Laboratories, Inc. (NASDAQ: IDXX), today announced that it has received the CE mark certification in the European Union for its OPTI SARS-CoV-2 RT-PCR laboratory test kit for the detection of SARS-CoV-2, the virus that causes COVID-19. ...

ByOPTI Medical Systems, Inc.


MiraDx Offering COVID-19 PCR Testing for California Skilled Nursing Facilities

MiraDx Offering COVID-19 PCR Testing for California Skilled Nursing Facilities

LOS ANGELES--(BUSINESS WIRE)--MiraDx, a Los Angeles-based molecular genetics company that transitioned its CLIA-certified laboratory to provide COVID-19 PCR testing, is further expanding access to skilled nursing facilities (SNFs) in California. ...

ByMiraDx


OPTI Medical Systems Receives US FDA Emergency Use Authorization for Its OPTI SARS-CoV-2 RNA PCR Test Kit for Detection of the Virus Causing COVID-19

OPTI Medical Systems Receives US FDA Emergency Use Authorization for Its OPTI SARS-CoV-2 RNA PCR Test Kit for Detection of the Virus Causing COVID-19

We have validated the OPTI SARS-CoV-2 RT-PCR test kit with existing laboratory customers and are advancing our initial distribution to select certified laboratories using common PCR platforms,” said Olivier te Boekhorst, Corporate Vice President and General Manager of OPTI Medical Systems, IDEXX Water, and IDEXX Livestock, Poultry and ...

ByOPTI Medical Systems, Inc.


COVID 19 Initiative

COVID 19 Initiative

Aquasolution launches a Covid 19 project with two long time collaborators. Certilab Inc a reputable ISO certified laboratory and Aluquip Inc a specialized metal fabricator. Aquasolution has been implementing Ultra Violet sterilization units in potable water systems since 1985 The R & D project will focus on designing a state of the art large irradiation ...

ByAquasolution Technologies inc.


New Metabolic Biomarkers Open Door to Earlier Diagnosis, More Precise and Individualized Treatment of Children at Risk for Autism

New Metabolic Biomarkers Open Door to Earlier Diagnosis, More Precise and Individualized Treatment of Children at Risk for Autism

NeuroPointDX has developed and is commercializing testing panels to aid in the early diagnosis of ASD through its CLIA-certified laboratory. The NPDX ASD test identifies children with specific metabolic subtypes associated with ASD. ...

ByNeuroPointDX


Getting Personal with Precision Medicine – PharmaVOICE

Getting Personal with Precision Medicine – PharmaVOICE

NeuroPointDX has developed and is commercializing testing panels to aid in the early diagnosis of ASD through its CLIA-certified laboratory. NeuroPointDX’s CEO and co-founder Elizabeth Donley, who has a 22-year-old son with autism, says: “I know the struggle families face in getting a diagnosis and understanding the treatments to try. ...

ByNeuroPointDX

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