INV4
8 months ago
FDA grants marketing authorization for Invitae DNA
October 02, 2023
The US Food and Drug Administration (FDA) has granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel to identify genetic predisposition for multiple cancers.
The cancer panel is an in vitro diagnostic test that analyses 47 genes associated with cancers of the breast, ovary, uterus, prostate, and gastrointestinal system. It can also help individuals with already-diagnosed cancer by identifying potentially cancer-associated hereditary variants.
At-home genetic testing is becoming more common, with the US FDA clearing these tests for varied purposes. Last month, FDA cleared 23andMe to report 41 additional genetic variants of BRCA1 and BRCA2 genes. The agency also granted the company the first-ever Predetermined Change Control Plan (PCCP), which outlines the protocols and acceptance criteria to validate BRCA1 and BRCA2 variants.
Genetic testing is a growing area of research. There are over 500 products in development for genetic testing, according to GlobalData.
“This test can assess multiple genes in a single test by using next-generation sequencing, which has proven helpful in providing insight into genetic variants with sensitivity and speed,” said Jeff Shuren, director of the FDA’s Centre for Devices and Radiological Health.
“Today’s [29 September] action can provide an important public health tool that offers individuals more information about their health, including possible predisposition for certain cancers, which can help guide physicians to provide appropriate monitoring and potential therapy, based on discovered variants.”
The FDA cautioned that the prescription test is “not intended to identify or evaluate all known genes that can provide insight into predisposition for cancer,” and that the test can report false positive and false negative test results.
Unlike at-home testing kits, the specimen for Invitae’s test is collected at a point of care centre, such as a doctor’s office. Following testing, the results are interpreted using criteria consistent with those established by appropriate professional organisations or accredited boards.
The genes included in testing include hereditary breast and ovarian cancer syndrome (BRCA1 and BRCA2), Lynch syndrome associated genes (MLH1, MSH2, MSH6, PMS2 and EPCAM), CDH1 (mainly associated with hereditary diffuse gastric cancer and lobular breast cancer) and STK11 (associated with Peutz-Jeghers Syndrome).
In addition to the clearance, the FDA also created a new regulatory classification that similar products can use to obtain 510(k) clearance by demonstrating equivalence.
FDA grants marketing authorization for Invitae DNA was originally created and published by Medical Device Network, a GlobalData owned brand.
https://www.msn.com/en-us/health/other/fda-grants-marketing-authorization-for-invitae-dna/ar-AA1hzvMd
$NVTA
INV4
8 months ago
FDA Approves Invitae's DNA Test To Assess Predisposition For Certain Cancers
October 02, 2023
(RTTNews) - The U.S. Food and Drug Administration granted de novo marketing authorization for Invitae's Common Hereditary Cancers Panel, an in vitro diagnostic test to help detect dozens of cancer types.
It is the first marketing authorization for a DNA test to assess predisposition for hundreds of genetic variants associated with an elevated risk of developing certain cancers.
The Invitae Common Hereditary Cancers Panel, a prescription test, can also help identify potentially cancer-associated hereditary variants in individuals with already-diagnosed cancer.
The test evaluates DNA extracted from a blood sample to identify variants in 47 genes known to be associated with an elevated risk of developing certain types of cancer. For this prescription test, the specimen is collected at the point of care, such as a doctor's office, and sent to a laboratory for testing.
To validate the performance, Invitae tested over 9,000 clinical samples, and achieved =99.0% accuracy for all tested variant types.
Meanwhile, the test is not intended to identify or evaluate all known genes that can provide insight into predisposition for cancer.
For the approval, the FDA reviewed the Invitae Common Hereditary Cancers Panel under its De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.
Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said, "This test can assess multiple genes in a single test by using next-generation sequencing, which has proven helpful in providing insight into genetic variants with sensitivity and speed."
The Invitae Common Hereditary Cancers Panel can be used as a tool to help identify inherited causes of various types of cancers. Patients are asked to speak with a healthcare professional to discuss any personal/family history of cancer, as such information can be helpful in interpreting test results.
There are more than 100 different documented types of cancer, according to the Centers for Disease Control and Prevention. In the United States, cancer is the second leading cause of death behind heart disease.
The FDA noted that the risks associated with the test mainly include the possibility of false positive and false negative test results, along with possible misunderstanding of the results.
FDA said the latest action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA's 510(k) premarket process.
https://www.nasdaq.com/articles/fda-approves-invitaes-dna-test-to-assess-predisposition-for-certain-cancers
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FDA Gives Marketing Authorization to Invitae Test for Cancer Genes
September 29, 2023
The Food and Drug Administration gave de novo marketing authorization to a diagnostic test that can help detect genes associated with elevated risk of developing cancers.
The FDA said that the test, called the Invitae Common Hereditary Cancers Panel, was an in vitro diagnostic test designed to identify 47 genes which are linked to an elevated risk of cancer.
The de novo premarket review is a regulatory pathway through the FDA for low- to moderate-risk new medical devices.
The FDA said the approval would allow subsequent tests of the same type to go through a potentially quicker and cheaper pre-market process.
Invitae tested over 9,000 samples and found an accuracy greater than or equal to 99%.
https://ih.advfn.com/stock-market/NYSE/invitae-NVTA/stock-news/92163528/fda-gives-marketing-authorization-to-invitae-test
$NVTA
LessIsMore
8 months ago
NVTA granted FDA Marketing Authorization for DNA Test
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US Food and Drug Administration
FDA Grants First Marketing Authorization for a DNA Test to Assess Predisposition for Dozens of Cancer Types
Today, the U.S. Food and Drug Administration granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test that can help detect hundreds of genetic variants associated with an elevated risk of developing certain cancers. The test can also help identify potentially cancer-associated hereditary variants in individuals with already-diagnosed cancer. The test, which is the first of its kind to be granted FDA marketing authorization, evaluates DNA extracted from a blood sample to identify variants in 47 genes known to be associated with an elevated risk of developing certain types of cancer.
“This test can assess multiple genes in a single test by using next-generation sequencing, which has proven helpful in providing insight into genetic variants with sensitivity and speed,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Today’s action can provide an important public health tool that offers individuals more information about their health, including possible predisposition for certain cancers, which can help guide physicians to provide appropriate monitoring and potential therapy, based on discovered variants.”
According to the Centers for Disease Control and Prevention, there are more than 100 different documented types of cancer, a disease in which abnormal cells divide out of control and are able to invade other tissue. It is the second leading cause of death in the United States behind heart disease.
The Invitae Common Hereditary Cancers Panel can be used as a tool to help identify inherited causes of various types of cancers. Patients should speak with a healthcare professional, such as a genetic counselor, to discuss any personal/family history of cancer, as such information can be helpful in interpreting test results. Importantly, this test is not intended to identify or evaluate all known genes that can provide insight into predisposition for cancer.
For this prescription test, the specimen is collected at the point of care, such as a doctor’s office, and sent to a laboratory for testing. The clinical interpretation of the variants is based on evidence from published literature, public databases, prediction programs and Invitae’s internal curated variants database using Invitae's variant interpretation criteria consistent with those established by appropriate professional organizations or accredited boards. Some of the most clinically significant genes that the test identifies are: BRCA1 and BRCA2, which are genes with known associations to hereditary breast and ovarian cancer syndrome, Lynch syndrome associated genes (MLH1, MSH2, MSH6, PMS2 and EPCAM), CDH1 (mainly associated with hereditary diffuse gastric cancer, and lobular breast cancer) and STK11 (associated with Peutz-Jeghers Syndrome).
The FDA reviewed the Invitae Common Hereditary Cancers Panel under the FDA’s De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. To validate the performance, Invitae tested over 9,000 clinical samples, and achieved =99.0% accuracy for all tested variant types.
The risks associated with the test are mainly the possibility of false positive and false negative test results, as well as possible misunderstanding of the results. False negative test results may provide a false sense of assurance and these patients may not receive appropriate surveillance or clinical management. False positive test results could lead to inappropriate decision-making regarding healthcare and lifestyle, which can be associated with other undesirable clinical consequences. Further, since this test is not intended to identify or evaluate all known genes associated with a predisposition for cancer, and genetics are not the only factor in development of cancer, there is a risk of patients misunderstanding that they still have some risk of developing cancer following a negative test result. These risks are mitigated by the analytical performance validation, clinical validation and appropriate labeling of this test.
Along with this De Novo authorization, the FDA is establishing special controls that define the requirements related to labeling and performance testing. For example, accuracy for reporting of substitutions, insertions/deletions and copy number variants must be =99.0% for positive agreement and =99.9% for negative agreement with a validated orthogonal method. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type.
Today’s action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device, which may save a developer time and expense compared to other review pathways.
Invest-in-America
2 years ago
NVTA: GAIL!!! Damn it!! I was gonna jump on this when at 83% Up, hours ago!! But, my whole router, connections, etc., CRASHED --- as I had noted to you HOURS ago!! I HATE when this happens!!!! I kid you NOT, Girl!! In fact, I'm on a STARBUCKS (free) WiFi right now, which is HOW I discovered this runner --- and, as noted, it was already IN my E-Turd WATCH LIST, which I had SCRAMBLE to create hours ago when I had LOST CONTACT with all of my FIDELITY watch lists!! FLUCK!!!
[img][https://media.giphy.com/media/hbW8RFIQCQ8Xh4eIRb/giphy.gif/img]
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