PreventionGenetics Receives FDA Approval for its Companion Diagnostic Genetic Test as a Class II Medical Device

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Developed in collaboration with Rhythm Pharmaceuticals, the test is the first to be cleared by the FDA Class II Molecular Companion Diagnostic Device

MARSHFIELD, Wis., June 30, 2022 /PRNewswire/ — PreventionGenetics, a subsidiary of Exact Sciences Corp., announced today that it has recently obtained marketing authorization for the POMC/PCSK1/LEPR Companion Diagnostic Genetic Testing (CDx) as a Class II device by the Center for Devices and Radiological Health (CDRH), a division of the Food and Drug Administration (FDA). PreventionGenetics, an accredited germline DNA testing laboratory offering genetic testing to patients and physicians worldwide, developed the test in conjunction with Rhythm Pharmaceuticals, Inc.

The need for a diagnostic test to confirm variants in POMC, PCSK1 Where LEPR genes interpreted as pathogenic, probably pathogenic or of uncertain significance (VUS) have been added to the IMCIVREE label® (setmelanotide), a product marketed by Rhythm Pharmaceuticals that was approved by the FDA in 2020 for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to POMC, PCSK1, or LEPR deficiency .

There is an important distinction between general obesity – a multifactorial condition influenced by several genes and environmental factors – and diseases of obesity caused by monogenic (monogenic) variants.1 Like many other genetic diseases, monogenic obesity is extremely rare, with a prevalence of less than 4% in people with early onset obesity.2.3 Identifying these patients through genetic testing allows them to be matched with targeted therapy, helping to alleviate an otherwise debilitating condition.

“We are proud to play a role in identifying people with severe obesity who could benefit from taking IMCIVREE, the first FDA-approved treatment for people with severe obesity potentially caused by certain genetic deficiencies. “, said Eric CoudePhD, FACMG, Associate Laboratory Director at PreventionGenetics.

IMCIVREE is not indicated for the treatment of obese patients with suspected POMC, PCSK1 or LEPR deficiency with POMC, PCSK1 Where LEPR variants classified as benign or probably benign, or other types of obesity unrelated to POMC, PCSK1 or LEPR deficiency, or other approved indications, including obesity associated with other genetic syndromes and general (polygenic) obesity.

In clinical trials, IMCIVREE was generally well tolerated. Disturbance of sexual arousal, depression and suicidal ideation, increased skin pigmentation and darkening of pre-existing moles, and benzyl alcohol toxicity in neonates and low birth weight infants can occur. The most common side effects were skin hyperpigmentation, injection site reactions and nausea.

The POMC/PCSK1/LEPR The Companion Diagnostic Genetic Test (CDx) is intended for in vitro diagnostic use only and should be ordered by a qualified professional in accordance with clinical laboratory regulations. For more information on PreventionGenetics and the companion diagnostic test, visit https://www.preventiongenetics.com/sponsoredTesting/Rhythm/CDX.

IMCIVREE® (setmelanotide) Indication

In United StatesIMCIVREE is indicated for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to:

  • Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency as determined by an FDA-cleared test demonstrating variants in POMC, PCSK1 Where LEPR genes interpreted as pathogenic, probably pathogenic or of uncertain significance (VUS)
  • Bardet-Biedl Syndrome (BBS)

Usage limits

IMCIVREE is not Indicated for the treatment of patients with the following conditions as IMCIVREE is not expected to be effective:

  • Obesity due to suspected POMC, PCSK1 or LEPR deficiency with POMC, PCSK1 Where LEPR variants classified as benign or probably benign
  • Other types of obesity unrelated to POMC, PCSK1 or LEPR deficiency, or BBS, including obesity associated with other genetic syndromes and general (polygenic) obesity

WARNINGS AND PRECAUTIONS

Disturbance of sexual arousal: Spontaneous penile erections in men and sexual adverse reactions in women have occurred. Advise patients that these events can occur and instruct patients who have an erection lasting longer than 4 hours to seek urgent medical attention.

Depression and suicidal thoughts: Depression and suicidal ideation occurred. Monitor patients for new onset or worsening of depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients have suicidal thoughts or behaviors, or if clinically significant or persistent symptoms of depression occur.

Skin pigmentation and darkening of pre-existing moles: A generalized increase in skin pigmentation and darkening of pre-existing moles occurred. Perform a full body skin examination before initiation and periodically during treatment to monitor for pre-existing and new pigmented lesions.

Risk of serious adverse effects from preservative benzyl alcohol in newborns and low birth weight infants: IMCIVREE is not approved for use in newborns or infants. Serious and fatal side effects, including “gasping syndrome”, may occur in neonates and low birth weight infants treated with drugs containing benzyl alcohol.

SIDE EFFECTS

  • The most common adverse reactions (incidence ≥20%) included skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and penile erection spontaneous.

USE IN SPECIFIC POPULATIONS

Treatment with IMCIVREE is not recommended during breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of treatment outweigh the potential risks to the fetus.

To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at 833-789-6337 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full prescribing information for additional important safety information.

1 https://www.ncbi.nlm.nih.gov/books/NBK573068/
2 https://pubmed.ncbi.nlm.nih.gov/15660521/
3 PreventionGenetics Diagnostic Tests Database

About PreventionGenetics

Founded in 2004 and located in Marshfield, Wis., PreventionGenetics is a CLIA and ISO 15189:2012 accredited laboratory owned by Exact Sciences. PreventionGenetics provides high quality genetic testing at fair prices with exemplary service to patients and clinicians worldwide, including comprehensive Whole Genome Sequencing testing, PGnome® and whole exome sequencing test, PGxome®.

About Exact Sciences Corp.

A leading provider of cancer screening and diagnostic tests, Exact Sciences relentlessly pursues smarter solutions that provide the clarity needed to take life-changing action, sooner. Building on the success of the Cologuard and Oncotype tests, Exact Sciences is investing in its product portfolio to support patients before and throughout their cancer diagnosis and treatment. Exact Sciences brings together visionary collaborators to advance the fight against cancer. For more information, please visit the company’s website at www.exactsciences.comfollow Exact Sciences on Twitter @ExactSciences or find Exact Sciences on Facebook.

About Rhythm Pharmaceuticals

Rhythm is a commercial-stage biopharmaceutical company committed to transforming the treatment paradigm for people with rare obesity-related genetic diseases. Rhythm’s precision medicine, IMCIVREE (setmelanotide), was approved in November 2020 by the U.S. Food and Drug Administration (FDA) for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to confirmed POMC, PCSK1 or LEPR deficiency by genetic testing and in July and September 2021, respectively, by the European Commission (EC) and Great Britain Medicines and Health Products Regulatory Agency (MHRA) for the treatment of obesity and control of hunger associated with genetically confirmed POMC biallelic loss of function including PCSK1, LEPR deficiency or deficiency biallelic acid in adults and children 6 years of age and older.

NOTE: PGnome and PGxome are registered trademarks of PreventionGenetics, an Exact Sciences Corporation company. All other trademarks and service marks are the property of their respective owners.

Forward-looking statements

This press release contains forward-looking statements regarding our expectations, anticipations, intentions, beliefs or strategies regarding the future. These forward-looking statements are based on assumptions made by us as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions and events to differ materially from those anticipated. Accordingly, you should not place undue reliance on forward-looking statements. Risks and uncertainties that could affect our forward-looking statements are described in the Risk Factors sections of Exact Sciences’ most recent annual report on Form 10-K and any subsequent quarterly reports on Form 10-Q, as well as in other reports. submitted by Exact Sciences. with the Securities and Exchange Commission. Exact Sciences disclaims any obligation to publicly update any forward-looking statements, written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Exact Sciences
Media Contact: Steph Spanos, [email protected]608-556-4380
Investor contacts: Megan Jones, [email protected]608-535-8815
EN-SET-2200154 06/2022

SOURCE PreventionGenetics

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