Alquest. provides global regulatory, clinical, and compliance support to manufacturers of in vitro diagnostics. We meet the needs of all size companies by providing both high-level expertise and hands-on project support. Because the FDA (through CDRH and CBER) regulates IVDs as medical devices, Alquest is the right subspecialized resource for you.
Recent Alquest Assigments - IVDs |
Product Type |
Project Description |
Prognostic assays for breast, colon and prostate cancers
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- Assist global manufacturer with strategic commercialization planning, including US and international regulatory requirements, resource planning and timelines.
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| Assay for tissue typing |
- Full clinical trial support for large U.S. manufacturer, including project management, resource planning, site selection and qualification, monitoring, data management, biostatistics, report writing.
|
Immunological assays for prostate, breast, and colon cancer |
- Provide regulatory counsel and FDA interaction support for European manufacturer.
|
Immunological and molecular diagnostics for use in in vitro fertilization |
- Assist global manufacturer with strategic commercialization planning, to include regulatory affairs, resource estimation and timelines.
|
Blood-based assay for screening of colon cancer
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- Provided regulatory counsel to venture capital group on likelihood, requirements and merits of FDA IVD vs CLIA pathways.
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Blood group reagents |
- Filed BLA Efficacy Supplement for blood group reagents
|
Immunological assay to detect neuro-degenerative disease |
- Assist European manufacturer with indications for use, regulatory pathway and FDA interactions.
|
Flow cytometry for stem cell enumeration |
- Clinical project management services for a manufacturer of IVD reagents and instrumentation
- Oversight and conduct of site selection and site qualification
- Protocol and case report form development
- Study conduct (monitoring and closeout)
- Serve as clinical operations representative for the manufacturer’s core development team and is responsible for working with staff to set and meet project timelines
|
Immunohisto-chemistry assay to detect prostate cancer |
- Regulatory assessment and strategy
- Pre-IDE meeting
- Clinical trial (impending)
|
26 monoclonal antibody based blood grouping reagents;
2 anti-human globulin products;
13 reagent red blood cell products; and supplements to 3 previously licensed reagents |
- Earned multiple BLA and BLA supplement approvals (Biologics License Applications)
- Project management
- Quality assurance program
- CMC (Chemistry Manufacturing and Controls) systems and procedures
- Process validation protocols and report writing
- Stability test protocols, test methods and acceptance criteria
- In-process product testing plans and acceptance criteria
- Established product specifications such as potency, specificity, microbial limits
- Facility and utility controls and prepared validation packages
- Statistical analysis of clinical data for final clinical report
- Served as client’s U.S regulatory contact for FDA interactions
|
Instrument and DNA primers for
K-RAS mutation detection kit |
- Regulatory assessment
- 510(k)
|
Point-of-care test for counting blood cells and quantifying hemoglobin content
|
- Regulatory assessment on modifications to blood cell analyzer
|
Assay to detect marker response to a drug therapy |
- Regulatory assessment
- Regulatory strategy
|
HgB A1C Point-of-Care Device |
- Site selection
- Data collection and management
- Study management
|
Immunohisto-chemistry assay to detect breast cancer |
- Regulatory assessment
- 510(k) submission
|
Genetic marker to detect human papillomavirus (HPV) |
|
Molecular genetics assay to detect cystic fibrosis |
- Site qualification
- Clinical monitoring
- Data management
- Statistical analysis
|
Cell separation product |
- Full project strategy development
- FDA meeting preparation and participation
- Manufacturing validation and Quality System support for antibody production
- Study management
- Clinical monitoring
- Biostatistics
- 510 (k)
|
Microarray-based karyotyping test |
- Regulatory assessment to explore FDA pre-IDE path versus CLIA lab certification
|
Numerous blood glucose monitors |
- Regulatory strategies
- CLIA waiver
- Numerous 510(k) submissions
- 510(k) submission
- Quality Systems implementation
- Study management
- Clinical monitoring
|
Genetic screening for congenital indication |
- Project strategy
- Protocol
- IRB approvals
- Sample procurement
- Data management
- Clinical monitoring
- Statistical analysis
|
Breath sensor array device for detection of lung cancer |
- Regulatory assessment
- Regulatory strategy
|
Reagents for Immunoassay Analyzer – chemistry assays, hormone level assays, etc. |
- Product Development Team Member (strategy development, review of testing documentation, labeling, etc.)
- Development and review of 510(k) submissions
- Development and review of international submissions (EU, Japan, etc)
- Development and review of request for classification
- Development of regulatory documentation for support of international clinical study
|
Reagent panel for ABO Typing |
- Clinical site monitoring
- Clinical data management for 10,000 samples
- Clinical report generation for BLA support
- Preparation and review of BLA submission
- Quality System support for reagent manufacturer
- Manufacturing validation and quality system support for antibody production
- FDA meeting preparation and participation
- FDA inspection preparation and participation (2 - foreign facilities)
|
Cancer tissue marker |
- Full project strategy development
- Review and development of 510(k) submission
- Clinical data management and report generation for 510(k) support
- FDA meeting preparation and participation (3x)
- Clinical study protocol design for PMA clinical support
- Clinical data management for 2,000+ subjects/samples
- Clinical site monitoring
- Quality System development, implementation and support
|
Hepatitis diagnostic |
- FDA meeting preparation and participation
- Product Development Team Member (Review testing, labeling, etc.)
- Regulatory submission strategy and review - PMA and 510(k)
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