GenoCraft Consulting LLC
From PCR to NGS — We help clinical labs build, validate, and grow with confidence.
At Genocraft, we partner with clinical laboratories to bring cutting-edge molecular testing to life. Whether you are starting from the ground up or expanding your test menu, we provide the expertise to design, validate, and launch high-quality assays that meet the highest regulatory standards. Our goal is simple: help your lab deliver reliable results that improve patient care while staying inspection-ready.
Services
Our consulting covers the full spectrum of molecular pathology. From PCR-based infectious disease and oncology panels to next-generation sequencing (NGS) for hereditary cancer, hematologic malignancies, and comprehensive tumor profiling, we guide your team through every step. We support laboratories with assay validations, workflow optimization, SOP development, quality management systems, and inspection preparation for CAP, CLIA, and NYSDOH requirements.
Why Choose Us
Led by physicians and certified molecular pathology experts, Genocraft brings first-hand experience in building and operating high-complexity labs. We’ve overseen lab build-outs, regulatory submissions, and successful inspections. We understand the challenges of balancing speed, cost, and compliance—and we design practical solutions that fit your unique environment.
Khaled Gamal, MD, SMB (ASCP)
Renowned subject matter expert in the field of precision medicine and molecular pathology. After receiving my medical degree and completing a residency in clinical pathology, I decided to devote my long-life career to molecular pathology, focusing on the study, development, and implementation of advanced molecular diagnostic techniques. This stemmed from my strong conviction that the future of medicine will be shaped mainly by molecular biomarker-based precision medicine.
I have directly overseen the establishment of the Molecular divisions in several molecular diagnostics companies, from the ground up, and have been consulting for many others. I bring visionary leadership to the growing, highly promising field of companion diagnostics as it offers continuing advancements in diagnostic products and services that enable personalized medicine.
Madelyn Andrews, MB (ASCP)
I took an interest in genetics early on in my career while studying at The State University of New York at New Paltz, where I participated in a research project which matched offspring DNA to paternal and maternal DNA, to decipher the genetic contribution of the father bird. After graduating with a Bachelor’s of Science in cellular and molecular biology, I started off my career as a Molecular Technologist.
During that time, I developed a well-rounded understanding of the ins and outs of all aspects of molecular diagnostics, focusing on assay development, re-designing means of quality control, and mastering the process of Next Generation Sequencing. I am currently devoted to innovating, redeveloping, and streamlining the processes traditionally used in hemo-oncology molecular laboratories.
As well as earning a B.S., I am nationally certified in Molecular Biology through the American Society of Clinical Pathology and hold a NYS clinical laboratory license for Molecular Biology.