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Avoiding Adverse Opioid Outcomes with Proactive Precision Care

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41DA053877-01
Agency Tracking Number: R41DA053877
Amount: $319,447.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIDA
Solicitation Number: DA19-020
Solicitation Year: 2019
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-07-01
Award End Date (Contract End Date): 2022-06-30
Small Business Information
Carmel, IN 46032-4431
United States
DUNS: 117594471
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 (513) 253-4684
Business Contact
Phone: (513) 253-4684
Research Institution
509 E 3RD ST
BLOOMINGTON, IN 47401-3654
United States

 Nonprofit College or University

Perioperative and prescribed opioids often result in costly and unpredictable adverse effects, including life-
threatening respiratory depression and long-term opioid use/misuse in vulnerable patients. The US FDA warns
against the use of codeine and tramadol in children due to postoperative anoxic brain injuries and deaths, and
in nursing mothers due to serious breathing problems and infantile death. There is an urgent and unmet critical
need for proactive risk identification and personalized precision analgesia to improve safety and effectiveness
of opioids in vulnerable populations. Proactive precision medicine, including preoperative genotyping and
personalized analgesia based on scientific evidence; regulatory warnings; CPIC guidelines; cost-effectiveness
and established insurance coverage for genotyping could minimize excess opioid use and harm associated
with the current trial and error, reactive medicine. Using a patent protected innovative multigene combinatorial
pharmacogenetic opioid risk prediction and decision algorithm, in this Phase 1 STTR application, OpalGenix,
Inc. proposes to validate the genetic signatures of adverse opioid outcomes in nursing mothers and their
babies after cesarean deliveries. OpalGenix team will partner with academic researchers and leverage non-
overlapping NIH R01 funding (HD089458 and HD096800) to complement this STTR application to pursue the
following two aims: 1) Validate and identify genetic risk factors associated with postoperative opioid adverse
effects in adult women undergoing cesarean section and their breastfed neonates, and 2). Develop an insurer
reimbursed multi-gene laboratory-developed test (LDT) for preoperative genetic risk prediction and decision
support for pediatric and adult surgical patients to prevent adverse opioid outcomes. OpalGenix will develop a
minimum viable product (MVP), a refined multi-gene panel in a CLIA certified laboratory with a robust
combinatorial pharmacogenetic prediction and decision support to personalize surgical analgesia algorithm
with precise opioid use in children and adults. This is expected to prevent common opioid adverse outcomes,
such as vomiting and rare life threatening and compromising outcomes like respiratory depression, chronic
persistent surgical pain (CPSP), opioid dependence, and opioid use disorder (OUD) in vulnerable pediatric and
adult surgical cohorts. A future Phase II STTR will focus on the FDA pre-approval for a CLIA LDT to identify
patients genetically pre-disposed to significant adverse opioid outcomes including overdose, OUD, and
Neonatal Opioid Withdrawal Syndome (NOWS). Based on the current opioid epidemic and projected $2.15
trillion economic burden of opioids between 2020 and 2040 in the US alone, a significant commercial market
exists for OpalGenix to proactively identify and effectively reduce postoperative opioid-related adverse effects,
CPSP, OUD, NOWS, and overdose while maximizing surgical pain relief in millions of Americans each year.PROJECT NARRATIVE
Opioids are among the most widely used and prescribed analgesics for children undergoing surgery and
post-cesarean surgical pain in nursing mothers, resulting in increased and unpredictable opioid-related
adverse outcomes, including respiratory depression and death in neonates, children, and nursing mothers.
Patent protected, innovative, cost-effective, clinically adaptable and commercially viable technology of
OpalGenix has significant public health relevance because it would improve safety and efficacy of opioids in
vulnerable populations by proactively identifying patients at risk for opioid-related serious adverse effects,
and enabling personalized opioid use with precision dosing.

* Information listed above is at the time of submission. *

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