Sudhakar Marla Email & Phone Number

Consulting Services: IVD, Medical Devices, Molecular Diagnostics, Assay Development, Technology Assessment, Strategy, Startup Oversight

Northbrook, IL, US

• Part of senior management. Delineated and executed company’s short-term and long-term strategic plans. Defined operational strategy, project plans, goals, and timelines. Managed IVD test menu development under.
• Led assay development efforts in the enteric and respiratory areas resulting in successful FDA clearance of the following IVD tests: Enteric Pathogens (EP) and Respiratory Panel (RP Flex)
• Directed the test consumable and lyophilized reagent development for Atlas, the company’s next generation platform. Ensured the test consumable was room-temperature stable and was a closed system during testing, both.
• Introduced multiple initiatives to control incoming quality of critical reagents including enzymes that reduced non-conformances to less than 5%, down from 15-20%
• Directed the development of a unique Enteric Pathogens test panel with ~30 targets spanning the majority of Enteric Pathogens including parasites, bacteria, and viruses
• Successfully managed a sample preparation program that required lysing the spectrum of pathogens including hardy parasites and delicate RNA viruses in stool backgrounds and deliver inhibition-free, high-efficiency.

Northbrook, IL, US

• Directed all assay development programs to populate company’s infectious disease IVD test menu. Collaborated closely with Clinical Affairs and Regulatory to ensure successful FDA and other regulatory clearances and.
• Led the development of sample-to-result, multiplexed molecular diagnostic/IVD tests for blood stream infections (sepsis) on the company’s Verigene Platform. Both multiplexed gram‑positive (BC‑GP) and gram-negative.
• Instrumental in obtaining PMDA approvals for BC-GP and BC-GN in Japan; these are the first sepsis IVD molecular tests to be approved in Japan
• Strengthened and grew the assay development team. Maximized efficiencies across all elements including Feasibility, Development, Validations, and Design Transfer to allow the development of multiple assays in parallel
• Directed a microbiology laboratory dedicated to support assay development needs; implemented infrastructure for curating organisms. Emphasized biosafety and drove sustainable initiatives, including eliminating the use.

Northbrook, IL, US

• Directed the infectious disease Assay Development program to populate the Verigene System’s IVD test menu. Worked collaboratively with Clinical and Regulatory Affairs.
• Directed the transfer and integration of “off-board” assay development activities, including nucleic acid extraction, multiplexed RT-PCR, and a gold nanoparticle probe-based end-point detection, on to a.
• Managed the development of a fully automated IVD test for detection of respiratory viruses on the Verigene System
• Collaboratively conducted multi-site clinical evaluations for the automated multiplexed respiratory virus test, and successfully collaborated on the FDA submission to obtain 510(k) clearances

Northbrook, IL, US

• Created, staffed, and managed company’s infectious disease division of Assay Development
• Technical lead and Program Manager for the development of company’s first infectious disease assay
• Led a lean Assay Development team from feasibility through FDA clearance including managing a multi-site clinical evaluation for a semi‑automated IVD test for the detection of respiratory viruses

• Developed company's proprietary detection technology, expanded capabilities, and applied the detection technology to develop novel detection assays.
• Awarded a multi-million dollar federal contract for the development of a biological warfare agent detection system: Contract was 1 of 6 federal awards out of a field of over 12,000 applicants
• Technical lead for the biological warfare agent contract. Expanded the scope of the contract. Delivered a ruggedized, field-ready detection device with a multiplexed biological warfare agent panel.
• Received a multi-million dollar NIH grant for the development of PCR-less SNP detection assays that led to company’s first FDA-cleared genetic test: Grant received one of the top scores in the study section
• Co-developed all aspects of the gold nanoparticle technology platform that allowed the breakthrough PCR-less SNP detection in unamplified human genomic DNA: Overcoming human genomic DNA complexity to permit SNP.

Doctor Of Philosophy (Ph.D.), Chemistry

Postdoctoral Fellow, Chemistry

Education record