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GeneDx Announces Publication of SeqFirst Study Demonstrating Need for First Tier Rapid Genomic Testing for Non-Critical Care Pediatric Inpatients in The Journal of Pediatrics

GeneDx Announces Publication of SeqFirst Study Demonstrating Need for First Tier Rapid Genomic Testing for Non-Critical Care Pediatric Inpatients in The Journal of Pediatrics

Business Wire25-06-2025
GAITHERSBURG, Md.--(BUSINESS WIRE)-- GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced new data from the SeqFirst study team conducted in partnership with the clinical genetics team at Seattle Children's supporting the application of rapid exome sequencing (rES) and rapid genome sequencing (rGS) as a first-tier test for non-critical pediatric inpatients. The study assessed the impact of using rES/rGS as a first-tier test for children receiving genetic consults in non-critical care settings. The researchers examined diagnostic rates before and after a new policy allowing rES/rGS as a first-tier test was implemented. An analysis published in The Journal of Pediatrics showed that rapid genome testing dropped the average time to a precise genetic diagnosis from almost ten months to less than two weeks.
'Pediatric inpatients often remain undiagnosed and stuck in limbo without answers or treatment as their conditions worsen and costs rise for way too long,' said Mike Bamshad, MD, FACMG, Professor of Pediatrics at the University of Washington School of Medicine and Division Chief of Genetic Medicine at Seattle Children's. 'The study demonstrated how a policy change allowing for rapid genomic testing as a first-tier test significantly reduced the time to diagnosis in non-critical care pediatric wards, enabling patients to receive timely treatments and potential better outcomes.'
Implementation of the SeqFirst approach in the clinical setting led to significant reductions in the time to a genetic diagnosis, with the average time dropping from 289 to 13 days following the policy change that enabled rES/rGS to be ordered as a first-tier test in non-critical care pediatric wards. Despite an increase in utilization of rES/rGS, the diagnostic yield remained high, exceeding 40 percent, comparable to rates in critical care settings. The acceleration of diagnoses enables earlier interventions, better care planning, and improved outcomes for children with rare and undiagnosed conditions.
'Access to rapid genomic testing shouldn't be limited by where a child is admitted in the hospital,' said Tara Wenger, MD, PhD, FACMG, Professor of Pediatrics at the University of Washington School of Medicine and Associate Medical Director, Inpatient Service at Seattle Children's. 'This study shows that when we remove outdated barriers and bring cutting-edge diagnostics to the broader inpatient setting, we can deliver faster answers, reduce uncertainty for families, and ensure more children benefit from the highest standard of genomic care, regardless of their level of acuity.'
Additional findings from the study:
Providers caring for patients in pediatric inpatient settings are good at recognizing which patients are appropriate candidates for genetic testing, with 91 percent of consults resulting in the geneticist recommending testing.
When rES/rGS is not used, cases may be lost to follow-up, which delays access to testing and therefore a diagnosis.
The rate at which a precise genetic diagnosis was made from the initial encounter was over 3 times higher when rES/rGS was implemented as a first line test.
'This study underscores a major opportunity to expand timely, precise genetic diagnoses in non-critical care inpatients, a setting where genomic testing remains underutilized,' said Britt Johnson, PhD, FACMG, SVP of Medical Affairs at GeneDx. 'As health systems aim to deliver care more efficiently, expanding rES/rGS access across pediatric inpatients should reduce costs, shorten hospital stays, minimize unnecessary procedures, and improve outcomes for patients and families.'
SeqFirst also published findings earlier this year in the American Journal of Human Genetics on the use of rapid genomic testing in the NICU.
About GeneDx
At GeneDx (Nasdaq: WGS), we believe that everyone deserves personalized, targeted medical care—and that it all begins with a genetic diagnosis. Fueled by one of the world's largest, rare disease data sets, our industry-leading exome and genome tests translate complex genomic data into clinical answers that unlock personalized health plans, accelerate drug discovery, and improve health system efficiencies. For more information, please visit genedx.com and connect with us on LinkedIn, Facebook, and Instagram.
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All periods presented have been retroactively adjusted to reflect the 1-for-50 reverse stock split effected on April 11, 2025. P3 HEALTH PARTNERS INC. and SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 OPERATING REVENUE: Capitated revenue $ 351,724 $ 374,306 $ 721,241 $ 758,440 Other patient service revenue 4,064 4,851 7,772 9,205 TOTAL OPERATING REVENUE 355,788 379,157 729,013 767,645 OPERATING EXPENSE: Medical expense 351,350 365,171 723,393 747,228 Premium deficiency reserve (5,967 ) (3,397 ) (12,929 ) (2,397 ) Corporate, general and administrative expense 23,295 26,610 48,294 54,011 Sales and marketing expense 151 414 332 736 Depreciation and amortization 21,083 21,693 42,135 43,232 TOTAL OPERATING EXPENSE 389,912 410,491 801,225 842,810 OPERATING LOSS (34,124 ) (31,334 ) (72,212 ) (75,165 ) OTHER INCOME (EXPENSE): Interest expense, net (10,145 ) (5,436 ) (18,870 ) (9,692 ) Mark-to-market of stock warrants 2,002 8,673 5,324 8,889 Other 583 291 901 628 TOTAL OTHER (EXPENSE) INCOME (7,560 ) 3,528 (12,645 ) (175 ) LOSS BEFORE INCOME TAXES (41,684 ) (27,806 ) (84,857 ) (75,340 ) INCOME TAX PROVISION (1,981 ) (968 ) (3,054 ) (3,040 ) NET LOSS (43,665 ) (28,774 ) (87,911 ) (78,380 ) LESS: NET LOSS ATTRIBUTABLE TO REDEEMABLE NON-CONTROLLING INTEREST (23,303 ) (16,754 ) (47,069 ) (47,660 ) NET LOSS ATTRIBUTABLE TO CONTROLLING INTEREST $ (20,362 ) $ (12,020 ) $ (40,842 ) $ (30,720 ) NET LOSS PER SHARE: Basic $ (6.23 ) $ (4.40 ) (12.52 ) (12.02 ) Diluted $ (6.23 ) $ (7.37 ) (12.52 ) (15.19 ) WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: Basic 3,267 2,732 3,263 2,556 Diluted 3,267 2,822 3,263 2,601 All periods presented have been retroactively adjusted to reflect the 1-for-50 reverse stock split effected on April 11, 2025. P3 HEALTH PARTNERS INC. and SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands) (unaudited) Six Months Ended June 30, 2025 2024 CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $ (87,911 ) $ (78,380 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 42,135 43,232 Equity-based compensation 3,271 3,073 Amortization of original issue discount and debt issuance costs 402 (91 ) Mark-to-market adjustment of stock warrants (5,324 ) (8,889 ) Premium deficiency reserve (12,929 ) (2,397 ) Changes in operating assets and liabilities: Health plan receivable 27,803 (34,762 ) Clinic fees, insurance, and other receivable (3,625 ) 775 Prepaid expenses and other current assets (1,747 ) (4,865 ) Other long-term assets (14,464 ) 60 Accounts payable, accrued expenses, and other current liabilities 6,200 30 Accrued payroll (1,560 ) 238 Health plan settlements payable (13,694 ) (12,141 ) Claims payable 948 55,752 Accrued interest 10,619 8,257 Operating lease liability (223 ) (164 ) Net cash used in operating activities (50,099 ) (30,272 ) CASH FLOWS FROM INVESTING ACTIVITIES: Proceeds from asset sale 50 — Net cash provided by investing activities 50 — CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from long-term debt, net of original issue discount 45,000 25,000 Payment of debt issuance costs (181 ) — Proceeds from liability-classified warrants and private placement offering, net of offering costs paid — 42,234 Proceeds from at-the-market sales, net of offering costs paid — 33 Deferred offering costs paid — (455 ) Payment of tax withholdings upon settlement of restricted stock unit awards — (103 ) Repayment of short-term and long-term debt (682 ) (1,040 ) Proceeds from short-term debt 1,137 1,871 Net cash provided by financing activities 45,274 67,540 Net change in cash and restricted cash (4,775 ) 37,268 Cash and restricted cash, beginning of period 44,102 40,934 Cash and restricted cash, end of period $ 39,327 $ 78,202 RECONCILIATION OF NET LOSS TO ADJUSTED EBITDA LOSS (in thousands, except PMPM) (unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Net loss $ (43,665 ) $ (28,774 ) $ (87,911 ) $ (78,380 ) Interest expense, net 10,145 5,436 18,870 9,692 Depreciation and amortization 21,083 21,693 42,135 43,232 Income tax provision 1,981 968 3,054 3,040 Mark-to-market of stock warrants (2,002 ) (8,673 ) (5,324 ) (8,889 ) Premium deficiency reserve (5,967 ) (3,397 ) (12,929 ) (2,397 ) Equity-based compensation 1,463 1,624 3,271 3,073 Other(1) (148 ) 2,276 (466 ) 2,012 Adjusted EBITDA loss $ (17,110 ) $ (8,847 ) $ (39,300 ) $ (28,617 ) Adjusted EBITDA loss PMPM $ (50 ) $ (23 ) $ (57 ) $ (38 ) (1) Other during the three and six months ended June 30, 2025 consisted of (i) interest income partially offset by (ii) severance expense in connection with reorganization of workforce and (iii) legal settlements and valuation allowance on our notes receivable. Other during the three and six months ended June 30, 2024 consisted of (i) interest income partially offset by (ii) severance and related expense in connection with our chief executive officer transition and (iii) legal settlements and valuation allowance on our notes receivable. MEDICAL MARGIN (in thousands, except PMPM) (unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Capitated revenue $ 351,724 $ 374,306 $ 721,241 $ 758,440 Less: medical claims expense (321,109 ) (333,217 ) (673,426 ) (680,799 ) Medical margin $ 30,615 $ 41,089 $ 47,815 $ 77,641 Medical margin PMPM $ 89 $ 107 $ 69 $ 102 RECONCILIATION OF GROSS PROFIT (LOSS) TO MEDICAL MARGIN (in thousands) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Gross profit (loss) $ 4,438 $ 13,986 $ 5,620 $ 20,417 Other patient service revenue (4,064 ) (4,851 ) (7,772 ) (9,205 ) Other medical expense 30,241 31,954 49,967 66,429 Medical margin $ 30,615 $ 41,089 $ 47,815 $ 77,641 RECONCILIATION OF TOTAL OPERATING EXPENSE TO ADJUSTED OPERATING EXPENSE (in thousands) (unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Total operating expense $ 389,912 $ 410,491 $ 801,225 $ 842,810 Medical expense (351,350 ) (365,171 ) (723,393 ) (747,228 ) Depreciation and amortization (21,083 ) (21,693 ) (42,135 ) (43,232 ) Premium deficiency reserve 5,967 3,397 12,929 2,397 Equity-based compensation (1,463 ) (1,624 ) (3,271 ) (3,073 ) Other (244 ) (2,541 ) (182 ) (2,593 ) Adjusted operating expense $ 21,739 $ 22,859 $ 45,173 $ 49,081 View source version on Contacts Ryan HalstedInvestor RelationsGilmartin Groupir@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

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