Invitae Launches Expanded Pharmacogenomics Panel and Specialized Mental Health Panel

- New 38-gene testing panel and clinical decision support tool analyzes a patient's genetics and co-medications for their impact on drug and dose personalization -

SAN FRANCISCO, May 19, 2022 /PRNewswire/ -- Invitae (NYSE: NVTA), a leading medical genetics company, today announced the commercial availability of the expanded Invitae Pharmacogenomics (PGx) Panel which includes the specialized Invitae Pharmacogenomics Mental Health Panel and access to a clinical decision support tool (CDST). With this launch, Invitae now has one of the most comprehensive commercially available PGx panels in the industry. In addition to mental health medications, the panel aligns with PGx-specific guidelines and published evidence that affects hundreds of commonly used medications, including frequently prescribed medications for high-risk patients in primary care, cardiology, endocrinology, pain management and oncology.

Nearly one in four patients has been prescribed medications for which they are predicted to have an atypical response due to their genetics. Given the compelling evidence that patient care can benefit from this information, PGx testing is poised to become the standard of care across all medical prescribing, utilizing both broad panels and specialized tests as available. However, accomplishing the goal of integrating PGx into standard of care requires more support for healthcare providers to recognize the utility of PGx testing and implement it in their practices. 

Major progress is being made at the state and federal level to remove barriers to adoption of PGx. Medicare local coverage determinations (LCDs) have rolled across the country aligning PGx testing coverage with the evidence. Congress also recently introduced the Right Drug Dose Now Act, which, if passed, would increase awareness of and access to PGx. States have also made moves to encourage the use of pharmacogenetics in clinical care; for example, legislation recently introduced in California is designed to align Medi-Cal coverage for pharmacogenomics with Food and Drug Administration (FDA) and Clinical Pharmacogenetics Implementation Consortium (CPIC) evidence. With the tools to successfully utilize PGx, providers can potentially reduce adverse drug effects, including side effects and treatment failures, save time, reduce costs and improve patient care.

Invitae Pharmacogenomics Panel
The Invitae Pharmacogenomics Panel includes 38 genes, covering the genes and variants affecting 98% of the medicines that according to CPIC and FDA can lead to an actionable major or moderate drug-gene interaction; this 98% figure does not include genes and variants that are ordinarily tested for diagnosis of specific diseases but may also impact drug therapy.

Furthermore, access to Invitae's CDST, YouScript, is included with testing. YouScript is one of the most comprehensive medication management analytics and clinical decision support software offerings on the market employing over 17,000 curated references and product inserts to simulate a team of clinical pharmacists delivering real-time, evidence-based guidance. YouScript aids providers in mitigating the risk of potential drug-gene and drug-drug-gene interactions.

A recent study shows that using Invitae's YouScript Precision Prescribing Software and PGx testing reduce re-hospitalizations and emergency department visits by 52% and 42% respectively saving an estimated $4,382 per patient in 60 days. Considering that the U.S. spent an estimated $528 billionon non-optimized medications in 2016, exceeding the cost of the drugs themselves or any major chronic disease, making PGx testing and YouScript more widely available could result in substantial care improvements and cost reductions.

"Ninety-nine percent of patients have genetic variants that can impact medication response making pharmacogenomics a foundational element for any precision medicine program," says Kristine Ashcraft, medical affairs director, pharmacogenomics at Invitae. "At Invitae, we pride ourselves on ease-of-use, so we offer both genetic testing and clinical decision support to enable clinicians to easily benefit from genetic insights when making prescription choices at the point of care."

Invitae Pharmacogenomics Mental Health Panel 
The panel aligns with some payer coverage that limits the number of genes covered for mental health. Psychiatrists and other doctors have been increasingly using PGx testing in mental health treatment because the majority of mental health medications have evidence-based PGx guidance and utilization of PGx in their patients has been shown to reduce the risk of side effects, lead to more rapid stabilization with reduced medication switching, and increase the chance that patients can successfully manage their conditions. Non-personalized prescribing can have serious consequences. One study found that patients with unrecognized PGx variants significantly impacting response to es(citalopram) were victims of suicide 34.3% more often than individuals without variants affecting response to the drug. 

"In the U.S. alone, over 20% of adults take five or more medications every day and one of the most commonly prescribed drug types is antidepressants," continues Ashcraft. "This trend highlights the need to bring PGx testing into mainstream medical care, making it the standard, especially when treating polypharmacy patients and those with mental health conditions."

To learn more about Invitae's expanded PGx testing, visit Invitae.com. 

¹ https://cpicpgx.org/genes-drugs/; https://www.fda.gov/medical-devices/precision-medicine/table-pharmacogenetic-associations 
² https://cpicpgx.org/genes-drugs/
https://www.fda.gov/medical-devices/precision-medicine/table-pharmacogenetic-associations  
³ https://www.futuremedicine.com/doi/10.2217/pme.15.47 
⁴ https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2735464
⁵ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4540033/'; https://pubmed.ncbi.nlm.nih.gov/26086890/; https://pubmed.ncbi.nlm.nih.gov/32045941/
⁶ U.S. Census Bureau (2017). 2017 national population projection tables: Main series. Retrieved from https://www.census.gov/data/tables/2017/demo/popproj/2017-summary-tables.html

About Invitae
Invitae Corporation (NYSE: NVTA) is a leading medical genetics company, whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time and lower prices. For more information, visit the company's website at invitae.com.

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the availability, features and potential impact of the company's products; the company's belief that PGx testing is poised to become the standard of care across all medical prescribing; the company's beliefs regarding legislative progress to remove barriers to the adoption of PGx; and the potential benefits of PGx testing. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the company's history of losses; the company's ability to compete; the company's failure to manage growth effectively; the company's need to scale its infrastructure in advance of demand for its tests and to increase demand for its tests; the company's ability to use rapidly changing genetic data to interpret test results accurately and consistently; security breaches, loss of data and other disruptions; laws and regulations applicable to the company's business; and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2022. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements.

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SOURCE Invitae Corporation