On November 6, 2023 PharmaMar (MSE:PHM) has reported receipt of a payment of $10 million from Janssen Products LP after reaching a commercial milestone for Yondelis (trabectedin) in the United States as defined in the licensing agreement (Press release, PharmaMar, NOV 6, 2023, View Source [SID1234637044]).

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In August 2019, PharmaMar entered into a new licensing agreement with Janssen, which replaced a 2001 licensing agreement, under which Janssen retained the right to sell and distribute, on an exclusive basis, Yondelis in the USA.

Today, Yondelis is approved in more than 70 countries for the treatment of Soft Tissue Sarcoma and in some of these countries for ovarian cancer as well.

On November 6, 2023 Orum Therapeutics ("Orum"), a clinical-stage private biotechnology company pioneering Dual-Precision Targeted Protein Degradation (TPD² ) and Targeted Protein Stabilization (TPS² ), reported that they have entered into a definitive agreement under which Bristol Myers Squibb has acquired Orum’s ORM-6151 program (Press release, Orum Therapeutics, NOV 6, 2023, View Source [SID1234637043]). ORM-6151 is a first-in-class, anti-CD33 antibody-enabled GSPT1 degrader that has received the FDA’s clearance for Phase 1 for the treatment of patients with acute myeloid leukemia or high-risk myelodysplastic syndromes.

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"We believe this agreement with Bristol Myers Squibb, a global leader in cancer with a strong legacy in protein degradation, validates Orum’s unique Dual-Precision Targeted Protein Degradation approach, which we pioneered to improve the therapeutic window and realize the full potential of targeted protein degraders through precision delivery to cancer cells via antibody drug conjugates," said Sung Joo Lee, Ph.D., CEO of Orum Therapeutics. "We are excited that Bristol Myers Squibb has acquired our ORM-6151 program with proprietary GSPT1 degraders, first-in-class targeted protein degraders with the potential to make an impact for patients with cancer."

Under this transaction, Bristol Myers Squibb has acquired Orum’s ORM-6151 program for an upfront payment of $100 million, and Orum Therapeutics is eligible to receive milestone payments for a total deal value of $180 million. Further details were not disclosed.

Perella Weinberg Partners acted as financial advisor, and Sterne Kessler Goldstein & Fox, and Skadden, Arps, Slate, Meagher & Flom LLP served as legal advisor to Orum Therapeutics.

About Orum’s GSPT1 Platform Using the TPD² Approach

Orum’s GSPT1 platform uses the company’s unique Dual-Precision Targeted Protein Degradation (TPD²) approach to build novel targeted protein degraders combined with the precise tumor cell delivery mechanisms of antibodies to generate innovative, first-in-class, tumor-selective TPDs for the treatment of cancer. Orum has developed new molecular glue degrader payloads to specifically degrade an intracellular target protein within cancer cells via the E3 ubiquitin ligase pathway. Conjugated to antibodies, the payloads are designed to be delivered specifically to cancer cells and degrade the intracellular target protein GSPT1 and cause tumor cell death.

On November 6, 2023 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported financial results and operational updates for the quarter ended September 30, 2023 (Press release, ORIC Pharmaceuticals, NOV 6, 2023, View Source [SID1234637042]).

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"We continued making strong progress across our pipeline in the third quarter of 2023 with steady enrollment across our three clinical trials and the first presentation of clinical data for ORIC-114," said Jacob M. Chacko, MD, chief executive officer. "Initial data for ORIC-114 demonstrated clinical activity across multiple dose levels, including the first reported CNS complete response by an EGFR exon 20 inhibitor in a patient with untreated brain metastases, and a favorable safety profile. We are eager to continue advancing ORIC-114, and we also look forward to presenting initial clinical data for ORIC-533 in multiple myeloma and for ORIC-944 in prostate cancer over the coming quarters."

Third Quarter 2023 and Other Recent Highlights:

ORIC-114: a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor

Presented initial data from the ongoing Phase 1b dose escalation trial for patients with EGFR or HER2 exon 20 mutated non-small cell lung cancer (NSCLC) at the ESMO (Free ESMO Whitepaper) Congress 2023.
CNS activity was observed at multiple dose levels, including the first reported CNS complete response by an EGFR exon 20 inhibitor in a patient with documented untreated brain metastases.
Systemic responses were observed at multiple dose levels in heavily pre-treated NSCLC patients, characterized by 81% having received prior EGFR exon 20 targeted agents and 86% having CNS metastases at baseline.
At the potential RP2D of 75 mg QD, responses were observed in 2 of 3 EGFR exon 20 patients previously treated with amivantamab, including a confirmed complete response.
Responses were observed at multiple dose levels in HER2 exon 20 patients, including a confirmed partial response with 100% regression of all target lesions.
ORIC-114 demonstrated a favorable safety profile with mainly Grade 1 and 2 treatment related adverse events.
Presented preclinical data for ORIC-114 at ESMO (Free ESMO Whitepaper) Congress 2023 demonstrating potent activity across atypical mutations in EGFR.
The Phase 1b trial of ORIC-114 is ongoing to determine the candidate RP2Ds for dose optimization and the selection of the final RP2D. Expansion cohorts will enroll patients with EGFR exon 20 insertion mutations that are EGFR exon 20 inhibitor-naïve and that have been previously treated with amivantamab, as well as patients with HER2 exon 20 insertion mutations and atypical EGFR mutations. The company expects to report updated Phase 1b data in the first half of 2025.
ORIC-533: a highly potent, orally bioavailable small molecule inhibitor of CD73

Ongoing enrollment in a Phase 1b trial of ORIC-533 in patients with relapsed/refractory multiple myeloma.
The company will report initial safety, PK/PD, and preliminary antitumor activity data at the 65th ASH (Free ASH Whitepaper) Annual Meeting taking place December 9-12, 2023, in San Diego, CA.
ORIC-944: a potent and selective allosteric inhibitor of PRC2

Ongoing enrollment in a Phase 1b trial of ORIC-944 in patients with advanced prostate cancer.
Expect to report initial safety, PK/PD, and preliminary antitumor activity data in the first quarter of 2024.
Third Quarter 2023 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $256.2 million as of September 30, 2023, which the company expects will be sufficient to fund its current operating plan into late 2025.
R&D Expenses: Research and development (R&D) expenses were $22.4 million for the three months ended September 30, 2023, compared to $14.7 million for the three months ended September 30, 2022, an increase of $7.7 million. For the nine months ended September 30, 2023, R&D expenses were $60.7 million, compared to $45.4 million for the nine months ended September 30, 2022, an increase of $15.3 million. The increases were due to a net increase in external expenses related to the advancement of product candidates and discovery programs, as well as higher personnel costs.

G&A Expenses: General and administrative (G&A) expenses were $6.3 million for the three months ended September 30, 2023, compared to $6.0 million for the three months ended September 30, 2022, an increase of $0.3 million. For the nine months ended September 30, 2023, G&A expenses were $18.7 million, compared to $19.3 million for the nine months ended September 30, 2022, a decrease of $0.6 million. The decrease was primarily due to a decrease in professional fees.

IPR&D Expenses: Acquired in-process research and development (IPR&D) expenses of $5.0 million for the three and nine months ended September 30, 2022, were due to a development milestone payment related to ORIC-114. There were no such expenses for the three and nine months ended September 30, 2023.

On November 6, 2023 OPKO Health, Inc. (NASDAQ: OPK) reported business highlights and financial results for the three and nine months ended September 30, 2023 (Press release, Opko Health, NOV 6, 2023, View Source [SID1234637041]).

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Business highlights from the third quarter and subsequent weeks included the following:

ModeX Therapeutics Inc. (ModeX) was awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA) to develop novel multispecific antibodies against viral infectious disease threats. BARDA awarded a contract to ModeX to advance a platform and specific therapeutic candidates designed to address a range of public health threats in viral infectious diseases. The BARDA contract includes an initial $59 million award for the development, manufacturing and execution of a Phase 1 clinical trial for a next-generation MSTAR multispecific antibody with broad neutralizing activity against known variants of SARS-CoV-2. ModeX may be eligible to receive up to an additional $109 million from BARDA upon achieving milestones to develop multispecific antibodies targeting other viral pathogens, such as influenza.
ModeX advanced its antiviral and immune-oncology product pipeline. ModeX advanced its pipeline of antiviral and immune-oncology programs utilizing its next-generation multispecific antibodies. ModeX’s oncology programs are in the preclinical stage and at least one program is expected to enter the clinic in 2024. ModeX’s collaboration with Merck to develop MDX-2201, its vaccine for Epstein-Barr virus, is advancing. ModeX’s antiviral program is focused on developing multiple indications, including HIV, as well as other potential viral pathogens funded by BARDA.
NGENLA has now been approved in 48 markets including the U.S., Japan, EU Member States, Canada and Australia; sales are underway by Pfizer in over 23 countries including all priority global markets. NGENLA is the first once-weekly product approved for the treatment of pediatric growth hormone deficiency in Japan, Canada, Australia, the United Kingdom, Taiwan, United Arab Emirates and Brazil. OPKO is entitled to gross profit sharing in all global markets based on regional, tiered gross profit for both NGENLA and Genotropin. The U.S. region commenced gross profit sharing in August 2023.
New clinical data on RAYALDEE presented at Kidney Week 2023. OPKO Health presented late-breaking clinical data on RAYALDEE extended-release calcifediol in a poster presentation at the American Society of Nephrology Kidney Week. The data indicate that early, sustained and effective treatment of secondary hyperparathyroidism (SHPT) with RAYALDEE is associated with significantly slower progression of chronic kidney disease (CKD) in pre-dialysis patients. Data presented in an additional poster demonstrated that effective control of SHPT was achieved with RAYALDEE in both randomized clinical trials and in a real-world clinical experience trial.
OPKO Biologics entered into a research collaboration agreement with Entera Bio Ltd. to develop oral peptide tablet formulations for obesity and intestinal malabsorption syndromes. Under the agreement, OPKO will supply its long-acting GLP-2 peptide and certain oxyntomodulin (OXM) analogs for the development of oral tablet formulations using Entera’s proprietary oral delivery technology. Treatment with glucagon-like peptide-2 (GLP-2) analogs has been shown to improve the absorption of nutrients in patients with short bowel syndrome and to reduce parenteral support requirements. OXM is a naturally occurring peptide hormone found in the colon, with glucagon-like peptide-1 (GLP-1) and glucagon dual agonist activity that suppresses appetite and induces weight loss. OPKO has developed several proprietary, modified OXM analogs as potential candidates for treating obesity, including an injectable pegylated peptide that demonstrated significant reductions in weight loss and decreased plasma triglyceride levels in a 420-patient Phase 2b study.
BioReference Health continued executing its plan to improve operational efficiencies and enhance productivity, and is on track to return to profitability. BioReference continued to implement initiatives to reduce costs and rationalize its business in line with current testing volumes. Additionally, BioReference is focused on improving productivity and enhancing innovation of its higher-value specialty testing segments. Other efforts to return this business to profitability include expanding into new market segments, such as providing information for the pharmaceutical market.
Third Quarter Financial Results

Pharmaceuticals: Revenue from products in the third quarter of 2023 increased to $40.7 million from $32.4 million in the third quarter of 2022, driven by higher sales in OPKO’s international operating companies positively impacted by foreign currency exchange fluctuations of $2.9 million, and by an increase in sales of RAYALDEE to $7.3 million from $6.9 million in the prior-year period. Revenue from the transfer of intellectual property was $6.2 million in the third quarter of 2023 compared with $4.5 million in the 2022 period, which included revenue of $4.9 million and $1.4 million, respectively, of gross profit share for NGENLA in Europe and Japan and does not include an estimate from gross profit in the U.S. as our partner has not yet provided details post their launch in August 2023. Total costs and expenses were $72.3 million in the third quarter of 2023, up from $65.2 million in the prior-year period. The increase was mainly from the cost of revenue due to higher sales in OPKO’s international operating companies, higher inventory costs compared with the 2022 third quarter and unfavorable foreign currency exchange fluctuations of $2.2 million. Operating loss was $25.4 million in the third quarter of 2023 compared with $28.3 million in the third quarter of 2022.
Diagnostics: Revenue from services in the third quarter of 2023 was $131.7 million compared with $142.9 million in the prior-year period. Revenue decreased $10.0 million due to lower COVID-19 testing volume and reimbursement. Furthermore, clinical test reimbursement decreased by $6.6 million due to the mix of testing ordered, partially offset by a $5.4 million increase in clinical test volume. Total costs and expenses were $160.8 million in the third quarter of 2023 compared with $192.3 million in the third quarter of 2022, resulting in an operating loss of $29.1 million compared with an operating loss of $49.5 million in the 2022 period, an improvement of 41%. Operating loss improved primarily due to continued cost-reduction initiatives at BioReference as we strive to return to profitability.
Consolidated: Consolidated total revenues for the third quarter of 2023 were $178.6 million compared with $179.7 million for the comparable 2022 period. Operating loss for the third quarter of 2023 was $64.4 million compared with an operating loss of $87.8 million for the 2022 quarter. Net loss for the third quarter of 2023 included a mark-to-market adjustment of $8.3 million compared with $30.6 million in the 2022 period related to the decrease in the share price of GeneDx, resulting in a net loss of $84.5 million, or $0.11 per share, compared with a net loss of $86.1 million, or $0.11 per share, for the 2022 quarter.
Cash and cash equivalents: Cash and cash equivalents were $138.6 million as of September 30, 2023.
Conference Call and Webcast Information

OPKO’s senior management will provide a business update, discuss third quarter financial results, provide financial guidance and answer questions during a conference call and audio webcast today beginning at 4:30 p.m. Eastern time. Participants are encouraged to pre-register for the conference call using this link. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register can participate by dialing 833-630-0584 (U.S.) or 412-317-1815 (International). A webcast of the call can also be accessed at OPKO’s Investor Relations page and here.

A telephone replay will be available until November 13, 2023 by dialing 877-344-7529 (U.S.) or 412-317-0088 (International) and providing the passcode 8299382. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here.

On November 6, 2023 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported financial results for its third quarter ended September 30, 2023 (Press release, Myriad Genetics, NOV 6, 2023, View Source [SID1234637040]). The Company also provided an update on its business performance and 2023 financial guidance.

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"For the third quarter and year-to-date 2023, Myriad Genetics generated revenue growth of 14% and 15% over the prior year periods, respectively, excluding prior period collections1. In the third quarter of 2023, we continued to gain share in hereditary cancer testing, reporting a fifth consecutive quarter of volume growth year-over-year, and saw an acceleration in growth in our prenatal testing business, generating 20% year-over-year volume growth, excluding our Sneakpeek Early Gender DNA Test," said Paul J. Diaz, president and CEO, Myriad Genetics. "With industry leading gross margins and diligent cash management, we believe we have demonstrated our commitment to achieving profitability all while growing the business. We also improved our financial flexibility by expanding our credit facility. We remain confident in our ability to achieve our goal of adjusted profitability by the fourth quarter 2023 and sustainable 10%+ annual revenue growth for this full year and beyond."

Financial and Operational Highlights:
•Test volumes of 356,000 in the third quarter of 2023 increased 40% year-over-year, or 18% excluding contributions from the SneakPeek Early Gender DNA Test.
•The following table summarizes year-over-year quarterly testing volume changes in the company’s core product categories:
Three months ended
September 30, 2023 Nine months ended
September 30, 2023 Three months ended
September 30, 2022 Nine months ended
September 30, 2022

Year-over-Year Year-over-Year Year-over-Year Year-over-Year
Product volumes:
Hereditary cancer
18 % 20 % 4 % (6) %
Tumor profiling (1) % 7 % 3 % (4) %
Prenatal 85 % 78 % 0 % (2) %
Pharmacogenomics
19 % 24 % 34 % 40 %
Total 40 % 41 % 12 % 8 %

•Excluding contributions from the SneakPeek Early Gender DNA Test:
◦Prenatal testing volumes in the third quarter 2023 increased 20% year-over-year and was flat sequentially. In the second quarter 2023 prenatal testing volumes increased 12% year-over-year and 1% sequentially.
•The following table summarizes year-over-year quarterly revenue changes in the company’s core businesses by product category:
Three months ended Nine months ended
(in millions)
September 30, 2023 September 30, 2022
% Change
September 30, 2023
September 30, 2022
% Change
Product revenues:
Hereditary cancer
$
86.5
$
70.5 23 %
$
238.9
$
220.6 8 %
Tumor profiling
30.2 30.8 (2) % 103.5 96.9 7 %
Prenatal 39.5 22.1 79 % 111.3 87.3 27 %
Pharmacogenomics
35.7 33.0 8 % 102.9 95.5 8 %
Total $ 191.9 $ 156.4 23 % $ 556.6 $ 500.3 11 %

•Year-over-year revenue growth in the third quarter of 2023 reflects a $7.1 million change of estimate1 in the current quarter versus $(5.3) million change of estimate1 in the third quarter of 2022, excluding these change of estimates1, third quarter 2023 revenue increased 14% year-over-year, and hereditary cancer testing revenue increased 13% year-over-year.
•GAAP gross margins of 70.0% in the third quarter of 2023; adjusted gross margins for the third quarter of 2023 was 70.4%, an increase of 140.0 basis points from the second quarter of 2023.
•GAAP total operating expenses in the third quarter of 2023 were $194.4 million. Adjusted operating expenses in the quarter were $137.3 million.

•GAAP operating loss in the third quarter of 2023 was $60.1 million, which factors in an accrual related to the settlement of the Ravgen litigation of which $5 million was paid on October 31, 2023, $5 million is payable on or before October 31, 2024, and $2.75 million is payable on or before October 31, 2025. An additional $21.25 million is contingent on whether Ravgen is successful in resolving all outstanding patent re-examinations and litigation. If payable, the contingent amount would be payable over a five year period beginning no earlier than 2026. The adjusted operating loss in the quarter was $2.2 million.
•Ended the third quarter of 2023 with $86.3 million in cash, cash equivalents and marketable investment securities and $23.5 million available to draw under the asset-based credit facility, or total liquidity of $109.8 million. In addition, in October 2023, Myriad Genetics exercised its option to increase the maximum principal amount of its asset-based credit facility by $25.0 million to a total of $115.0 million.

Business Performance and Highlights:

Oncology
The Myriad Genetics Oncology business provides hereditary cancer testing, including the MyRisk hereditary cancer test for patients who have cancer. It also provides tumor profiling products such as the myChoice CDx companion diagnostic test, the Prolaris prostate cancer test, Precise Tumor molecular profile test and the EndoPredict breast cancer prognostic test. The Oncology business delivered revenue of $76.6 million in the third quarter of 2023.
•Third quarter hereditary cancer testing revenue and volumes in Oncology grew 21% and 15% year-over-year, respectively.
•Prolaris continued to see healthy demand as third quarter testing revenue and volumes grew 18% and 9% year-over-year, respectively. UnitedHealthcare has recently issued a positive medical policy covering Prolaris in the biopsy setting for all risk groups. This policy will take effect on January 1, 2024.
•Announced a collaboration with Memorial Sloan Kettering Cancer Center (MSK) to study the use of minimal residual disease (MRD) testing in breast cancer. The research project will use Myriad Genetics’ MRD testing platform, a tumor-informed high-definition assay that uses whole-genome sequencing to achieve high sensitivity and specificity for circulating tumor DNA (ctDNA). Myriad Genetics’ MRD test was selected for its anticipated higher sensitivity and specificity than many other ctDNA offerings.
•Integrated Absolute Risk Reduction (ARR) into the Prolaris Prostate Cancer Prognostic Test to help patients and providers make personalized treatment decisions regarding hormone therapy. Prolaris is the only biomarker test to quantify the benefits of adding androgen deprivation therapy (ADT) to radiation therapy (RT)2.

Women’s Health
The Myriad Genetics Women’s Health business serves women of all ancestries by assessing their risk of cancer and offers prenatal testing solutions for those who are pregnant or planning a family. The Women’s Health business delivered revenue of $79.6 million in the third quarter of 2023.
•Third quarter hereditary cancer testing volumes in Women’s Health grew 22% year-over-year, driven by competitive account wins and increased adoption by providers of MyRisk for patients whose family history puts them at a higher risk for cancer.
•Excluding contributions from the SneakPeek Early Gender DNA Test, prenatal testing volumes in the third quarter of 2023 grew 20% year-over-year.
•In collaboration with Onsite Women’s Health, a leading national provider of breast health services, we announced the launch of a new breast cancer risk assessment program to help more women understand their breast cancer risk. This program combines diagnostic imaging and genetic risk assessment utilizing MyRisk with RiskScore and patient education. The program is expected to enable affordable access to genetic testing and deliver personalized insights to better inform clinical decisions for millions of potential patients.
•MyRisk Hereditary Cancer Test with RiskScore now incorporates breast density using Tyrer-Cuzick version 8 (TCv8) to provide patients and providers with a more comprehensive look at their five-year and remaining lifetime risk for breast cancer. MyRisk with RiskScore is the first breast cancer risk model that includes breast density, personal/family clinical history and a polygenic risk score (PRS) based on genetically determined ancestry.
•As of October 2023, Myriad Genetics sold over 1 million SneakPeek Early Gender DNA Tests.
Pharmacogenomics
The Myriad Genetics Pharmacogenomics business consists of the GeneSight test that covers 64 medications commonly prescribed for depression, anxiety, attention deficit hyperactivity disorder, and other psychiatric conditions. GeneSight helps physicians understand how genetic alterations impact patient response to antidepressants and other drugs. In the pharmacogenomics category, the GeneSight test recorded revenue of $35.7 million in the third quarter of 2023.
•In the third quarter, Myriad Genetics added approximately 4,000 clinicians who ordered GeneSight for the first time.
•Enhanced GeneSight report will now include information on how a patient’s smoking status may impact their body’s metabolism of certain medications.

•Presented positive preliminary results from Phase 1 of a multi-phase study designed to better understand GeneSight’s ability to improve clinical outcomes and reduce healthcare costs. Based on data from over 20,000 patients in the Optum Labs Data Warehouse, in the first 180 days post GeneSight testing, total hospitalizations decreased by more than 25% and psychiatric hospitalizations decreased by more than 35%. Additional data and detail from this study is expected to be published in 2024.
•Building on a 2020 meta-analysis of the clinical utility of the GeneSight test, which included four prospective, controlled studies and 1,556 unique patients, Myriad Genetics has incorporated additional published studies to further measure the utility of combinatorial pharmacogenomics testing for the treatment of major depressive disorder (MDD). This updated meta-analysis continues to show that access to GeneSight improved MDD response and remission rates.