AYVAKIT® (avapritinib) Companion Diagnostic Test Enters Priority Review and Approval Process in China
BEIJING, July 26, 2021 (GLOBE NEWSWIRE) -- Genetron Holdings Limited (“Genetron Health” or the “Company”, NASDAQ: GTH), today announced that its AYVAKIT® (avapritinib) companion diagnostic (CDx) kit, developed in partnership with CStone Pharmaceuticals (“CStone”, HKEX: 2616) has entered the priority review and approval process under the National Medical Products Administration (NMPA) in China.
The test kit is the first companion diagnostic product developed in China to go through the NMPA’s accelerated review channel. This channel expedites the review of qualified medical devices that are deemed urgent and necessary, so that they can be applied sooner in clinical settings.
During the process, the Center for Medical Device Evaluation (CMDE) under the NMPA carries out a priority technical review, working closely with the company to expedite the process. Provincial food and drug authorities also make the review of the product a priority throughout their registered quality management systems. The product then goes through a priority administrative process under the NMPA, which approves the product at the end.
Gastrointestinal stromal tumor (GIST) patients with human platelet-derived growth factor receptor alpha (PDGFRA) gene mutations lack effective treatment drugs. AYVAKIT® has demonstrated remarkable efficacy and acceptable safety in Chinese patients with unresectable or metastatic GIST harboring PDGFRA exon 18 mutations, including D842V.
As a proprietary companion diagnostic for AYVAKIT®, the CDx kit can be used to effectively detect PDGFRA D842V gene mutation in GIST patients, providing accurate molecular diagnosis for targeted drug application which may translate into durable clinical benefits for these patients.
The AYVAKIT® CDx test kit is based on a real-time PCR fluorescent probe, specific primers, Taqman probes, and highly specific Taq enzymes to detect gene mutations. This enables the test kit to detect mutations with higher specificity and sensitivity in DNA samples. A clinical study utilizing the test kit was carried out at the Beijing Cancer Hospital, Harbin Medical University Cancer Hospital and Shanghai Tenth People's Hospital, demonstrating data on par with that of the Sanger sequencing method and exhibiting total coincidence rates of over 99%.
"I am very pleased that the AYVAKIT® companion diagnostics test kit has entered the NMPA priority review and approval process, distinguishing itself through innovative, original technology and strong performance data. The development of such companion diagnostics products can enable doctors to choose more suitable, targeted drugs for patients, while lowering the costs of drug development, accelerating the development process, and improving drug safety and effectiveness. Genetron Health is committed to exploring more innovative pathways for the development of new drugs and companion diagnostics, providing more choics for patient care," said Sizhen Wang, Co-Founder and CEO of Genetron Health.
“Precision medicine is one of CStone's core strategies. As the world's first therapeutic approved for GIST based on driver mutations, AYVAKIT® was approved by the NMPA in March 2021 after passing the NMPA’s priority review process. Molecular diagnosis has become imperative for GIST patients. I am very pleased that the AYVAKIT® companion diagnostic kit has also entered the priority review process. I look forward to the early approval of this diagnostic kit, so that more GIST patients in China can benefit from precision treatment,” said Dr. Archie Tse, Chief Scientific Officer of CStone.
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Safe Harbor Statement
This press release contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about the priority review and approval process in China, the collaboration with CStone for the joint development of a CDx test for avapritinib are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and a number of factors could cause actual results to differ materially from those contained in any forward-looking statement. In some cases, forward-looking statements can be identified by words or phrases such as “may”, “will,” “expect,” “anticipate,” “target,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions. Further information regarding these and other risks, uncertainties or factors is included in the Company’s filings with the SEC. All information provided in this press release is as of the date of this press release, and the Company does not undertake any duty to update such information, except as required under applicable law.
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