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Cigna let them in, who is next!
Any product in the healthcare sector can only be successful if the big boys let them in and the way they keep you out is thru not approving insurance coverage. We have finally overcome that hurdle and I've followed this stock since the approval of OVA1. I lost a good chunk of change on these type of stocks because they weren't allowed a seat at the table.
VRML now has a legitimate seat at the table and since they have a better product there is no reason for doctors or insurers not to utilize OVA1. Coupled with their other solutions and this stock really has unlimited growth potential. IMO selling the place for $10 (a billion market cap) to a bigger player would make sense, though the company could easily be worth billions of dollars down the road.
Vermillion Inc. Announces ASPiRA LABS Now Credentialed as Florida State Medicaid Provider
Fourth largest Medicaid population in the U.S.
April 14, 2020 08:00 ET | Source: Vermillion, Inc.
AUSTIN, Texas, April 14, 2020 (GLOBE NEWSWIRE) -- Vermillion, Inc. (NASDAQ: VRML) today announced its wholly owned subsidiary, ASPiRA LABS, is now credentialed with Florida’s State Medicaid program for an estimated additional 3.6 million credentialed Medicaid lives.
Florida has the fourth largest state Medicaid populations in the U.S. and ASPiRA is now credentialed in 4 of the top 5 states by Medicaid population size, including California, Pennsylvania, Texas and now Florida. The state of New York has the second largest state Medicaid population and ASPiRA LABS is in process of seeking credentials there. Florida brings the total credentialed Medicaid population to almost 50 M Medicaid lives, which is about 77% of the U.S. Medicaid population. This credentialing also allows ASPiRA LABS to seek participation as a network provider with commercial Medicaid health plans. ASPiRA LABS is the only U.S. provider for Vermillion’s proprietary OVA1® test, an FDA-cleared, ACOG recommended and CMS supported ovarian cancer risk assessment for women with a pelvic mass.
Credentialing is an important step towards gaining additional positive coverage for OVA1®, and follow-on commercial Medicaid contracts, especially when combined with peer-reviewed published evidence documenting OVA1®’s early detection and negative predictive value performance over CA125, and its marked performance in African American women as compared to CA125.
“Actively pursuing Medicaid providership is a key cornerstone to our Disparity Gap movement. We are pleased to announce ASPiRA’s enrollment as a participating provider with Medicaid in the state of Florida,” said Valerie Palmieri, President and CEO of Vermillion, Inc. "As stated on our most recent earnings call, it is now time that ALL women of every socioeconomic background receive the best care possible and we are proud and excited to play our part in making that happen.”
About Vermillion, Inc.
Vermillion, Inc. is transforming women’s health with the discovery, development and commercialization of innovative testing options and bio-analytical solutions that help physicians assess risk, optimize patient management and improve gynecologic health outcomes for women. OVA1®plus combines our FDA-cleared products OVA1® and OVERA® to detect the risk of ovarian malignancy in women with adnexal masses. Recently launched, ASPiRA GenetiXSM testing offers both targeted and comprehensive genetic testing options with a gynecologic focus. With over 10 years of expertise in ovarian cancer risk assessment, Vermillion has expertise in cutting-edge research to inform our next generation of products. Our focus is on delivering products that allow healthcare providers to stratify risk, facilitate early detection and optimize treatment plans. Visit our website for more information about our products at www.vermillion.com.
$VRML Just doing my DD here. But God this seems undervalued by a Mile. OVA1 has to become the standard. Cigna is just the first.
Incredible, I see and understand it fully now. WOW!
Vermillion Announces Cigna Preferred Contract Coverage for OVA1, Overa and Genetics Testing
March 27, 2020
AUSTIN, Texas, March 27, 2020 (GLOBE NEWSWIRE) -- Vermillion, Inc. (VRML), a bioinformatics-based women’s health company focused on gynecologic disease, announced yesterday that its wholly owned subsidiary, ASPiRA Labs, has signed a national preferred agreement with Cigna. This contract includes OVA1, (Multivariate Index Assay, MIA) our ACOG endorsed ovarian cancer risk assessment test, as well as Overa and all genetic testing offered by ASPiRA. This agreement with Cigna will expand ASPiRA Labs contracted coverage by an additional 16 million lives.
“We are excited to add one of the major national payers to the ASPiRA contracted payer network, allowing another 16 million lives to have access to all of ASPiRA’s testing as an in-network benefit,” said Valerie Palmieri, CEO of Vermillion. “This national agreement with Cigna is a major milestone for Vermillion and patients, as OVA1 continues on its trajectory to becoming the standard of care for ovarian cancer risk assessment. OVA1 is an FDA-cleared technology to assess ovarian cancer risk in women with pelvic masses inclusive of all ages, all stages. No comparable product exists on the market, with outstanding performance in premenopausal women, all cancer types and African American women.”
About Vermillion, Inc.
Vermillion, Inc. is transforming women’s health with the discovery, development and commercialization of innovative testing options and bio-analytical solutions that help physicians assess risk, optimize patient management and improve gynecologic health outcomes for women. OVA1®plus combines our FDA-cleared products OVA1® and OVERA® to detect risk of ovarian malignancy in women with adnexal masses. Recently launched, ASPiRA GenetiXSM testing offers both targeted and comprehensive genetic testing options with a gynecologic focus. With over 10 years of expertise in ovarian cancer risk assessment Vermillion has expertise in cutting-edge research to inform our next generation of products. Our focus is on delivering products that allow healthcare providers to stratify risk, facilitate early detection and optimize treatment plans. Visit our website for more information about our products at www.vermillion.com.
Vermillion Announces Two Independent Publications Showing OVA1® (MIA- Multivariate Index Assay) Demonstrates Improved Ovarian Malignancy Risk Detection in African-American Women
- Milestone data announced during Ovarian Cancer Awareness Month, which demonstrates OVA1’s superior sensitivity of ovarian cancer risk detection in both Caucasian and African American women versus other testing options, CA125 or ROMA-
September 04, 2019 08:00 AM Eastern Daylight Time
AUSTIN, Texas--(BUSINESS WIRE)--Vermillion, Inc. (Nasdaq: VRML), a bioanalytical-based women’s health company focused on gynecologic disease, today announced the publication of two independent studies demonstrating that OVA1® (Blood Multivariate Index Assay (MIA) for Ovarian Cancer Risk Assessment) improves ovarian cancer risk detection in women compared to alternative technology, such as CA125 and CA125 & HE4 (Risk of Malignancy Algorithm ROMA). With more than 80% of ovarian cancer being diagnosed in late stages1,2, these data support the National Ovarian Cancer Coalition’s mission for Ovarian Cancer Awareness Month, of earlier recognition of symptoms and earlier detection.2
Vermillion Announces Data During Ovarian Cancer Awareness Month Showing OVA1® Improves Ovarian Malignancy Risk Detection in African-American Women. #OCAM #OvarianCancer #OVA1
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The studies specifically demonstrate that OVA1 is markedly more sensitive in ovarian cancer detection in African-American women 79.2% for OVA1, vs. 33.3% compared to CA1253, and 79.1% v. 54.5% compared to CA125 plus HE4 (Risk of Malignancy Algorithm ROMA), when using the American College of Obstetricians and Gynecologists (ACOG) cutoff >200 CA125 U/ml3 for premenopausal women. In addition, even applying a more conservative 2007 cutoff for premenopausal women (CA125 >67 U/ml, Dearking 2007)4, OVA1® still outperformed CA125 whose sensitivity was only 62.5%.
“Recent studies have shown that African American women have lower CA125 levels than other ethnicities which could lead to under diagnosis of cancer in that population. Our results from the two new studies demonstrate that OVA1 is clearly superior to CA-125, as well as to ROMA, in ovarian cancer risk detection for women with pelvic masses, particularly in African American women” said Charles Dunton, M.D., Global Medical Director of Vermillion, and lead author. “By giving more women greater access to a better risk detection method, we can help correct the disparity in care offered to African-American women, who generally have poorer survival rates from ovarian cancer and currently face a greater risk of cancer not being detected.”
Key takeaways from the studies:
“Multivariate Index Assay Outperforms CA125 in Detection of Ovarian Malignancy in African American Women” authored by Dunton et al was published in Future Oncology; Published Online: Aug 2019; https://doi.org/10.2217/fon-2019-0310
OVA1 (MIA) in African American women is more sensitive than CA125; 79.2% v 33.3% (2007 ACOG)3 v 62.5% (2007 Dearking)4
OVA1 (MIA) in Caucasian women is more sensitive than CA125, 93.2% v 80.4%
“Multivariate Index Assay is Superior to CA125 and HE4 Testing in Detection of Ovarian Malignancy in African American Women” authored by Dunton et al, was published in Biomarkers in Cancer 11:1-4, 2019
OVA1(MIA) in African American women is more sensitive than ROMA: 79.1% v 54.5%
OVA1(MIA) in Caucasian women is more sensitive than ROMA: 93.2% v 82.9%
“This is very interesting data. This sort of research is critical to understand tumor marker and OVA1 (MIA) differences in race and ethnicity”, said Barbara Goff, MD. Professor and Chair of Obstetrics and Gynecology and affiliated researcher at the Fred Hutchinson Cancer Research Center, University of Washington School of Medicine. “It is so critically important to investigate the sensitivity of such detection methods based on the inherent differences in individual populations. This preliminary research points to a substantial step in the right direction.”
OVA1® is an FDA-cleared and ACOG endorsed blood test offered via ASPIRA Labs®, Vermillion’s wholly owned subsidiary. OVA1® proactively assesses the risk of ovarian malignancy from a simple blood test, as a pre-operative biopsy is not medically appropriate. Clinically, OVA1® objectively guides the patient treatment care plan for low risk and high-risk pelvic mass patients.
“Disparity in care continues to be a major global problem, and particularly for cancer risk detection and treatment for underserved women,” said Valerie Palmieri, President, and CEO of Vermillion, Inc. “We are proud that OVA1® is demonstrated to accurately identify more patients, especially African-American women, and help ensure that they get the proper treatment. We will continue to work to support the goals of Ovarian Cancer Awareness Month and give ALL women of every socioeconomic background access to the best possible methods of cancer risk detection.”
About Vermillion, Inc.
Vermillion, Inc. is dedicated to the discovery; development and commercialization of novel high-value diagnostic and bio-analytical solutions that help physicians diagnose, treat and improve gynecologic health outcomes for women. Vermillion, along with its prestigious scientific collaborators, discovers, develops, and delivers innovative diagnostic and technology tools that help women with serious diseases. The company’s initial in vitro diagnostic test, OVA1® (MIA), was the first FDA-cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, and represented a new class of software-based liquid biopsy in vitro diagnostics. In March 2016, Vermillion received FDA clearance for Overa®, a Multivariate Index Assay 2nd Generation (MIA2G) test with significantly improved specificity and ease of use.
Can Ovarian Cancer Be Found Early?
Only about 20% of ovarian cancers are found at an early stage. When ovarian cancer is found early, about 94% of patients live longer than 5 years after diagnosis.
https://www.cancer.org/cancer/ovarian-cancer/detection-diagnosis-staging/detection.html#:~:text=The%202%20tests%20used%20most,ultrasound%20wand%20into%20the%20vagina.
Vermillion Announces FDA Clearance of Overa®, Second Generation OVA1® Test
New Design with Improved OVA1 Specificity and Test Interpretation, Supports the Drive to Eliminate Off-Label Use of CA 125 Biomarker for Pre-Surgical Assessment of Ovarian Cancer Risk
Vermillion, Inc.
Mar 21, 2016, 09:57 ET
AUSTIN, Texas, March 21, 2016 /PRNewswire/ -- Vermillion, Inc. (NASDAQ: VRML), a bio-analytical solutions company focused on gynecologic disease, announced today the receipt of 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for the successor to Vermillion's OVA1® test for determining ovarian cancer risk in conjunction with independent clinical and imaging assessment prior to planned surgery for a women with a pelvic mass. The Second Generation OVA1 test, previously referred to as "OVA2", has been trademarked "Overa®."
Overa replaces two of the five OVA1 biomarkers with HE4 and FSH in order to improve specificity and reduce the need for physicians to determine menopausal status when interpreting the test. The test is run on a single Roche Cobas 6000 platform, and like OVA1, stratifies patients into low- or high-risk of malignancy on a scale of zero to ten. Whereas other ovarian cancer tests such CA 125, ROMA and OVA1 require patient reported or physician determination of menopausal status, Overa uses a single cutoff of 5, irrespective of menopause. As a result, there is lower possibility of error or confusion, reducing physician work, and simplifying interpretation and patient counseling about the result. Now physicians can offer women even greater peace of mind with the improved specificity and simplified interpretation made possible by Overa.
"Many women still do not receive the proper initial treatment for ovarian cancer," stated Dr. Robert Coleman, Department of Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center. Dr. Coleman, the lead author of the soon to be published Overa clinical validation study, added, "Overa is specifically designed to help us know which patients are low risk for malignancy and to better identify patients who are at high risk for having a malignancy and, therefore, would benefit from care with a Gynecologic Oncologist."
Vermillion's chief medical officer, Dr. Judy Wolf, added, "Overa addresses a critical need for a 'liquid biopsy' test to aid in the pre-surgical detection of ovarian cancer across all stages, all ages and histological subtypes. Overa's improved performance, coupled with our upcoming publications on clinical validation, should position Vermillion to offer early access programs with major healthcare systems. We are working to develop carepath protocols and effective local guidelines that will continue to advance our campaign to accurately identify more women with ovarian cancer."
"The FDA clearance of Overa represents a major achievement in Vermillion's mission to provide a vastly improved pre-surgical assessment of the likelihood of malignancy for ovarian cancer," said Valerie Palmieri, President and CEO of Vermillion. "As the first in its class to receive a second-generation FDA 510(k) clearance, Overa's proven diagnostic technology running on Roche Cobas 6000, lays a solid foundation for worldwide product and portfolio development to enable more women to benefit from our technology," Ms. Palmieri added.
Vermillion will report its fourth quarter and full year 2015 financial results on Thursday, March 24, 2016, rather than on Wednesday, March 30, 2016, as previously announced. There will be an investor conference call and webcast at 8:30am Eastern on March 24, 2016 to discuss such financial results.
FDA warns against widely used ovarian cancer screening test
By SHEILA KAPLANSEPTEMBER 7, 2016Reprints
Blood test female patient
WASHINGTON — The Food and Drug Administration on Wednesday warned women and their doctors that current screening tests for ovarian cancer are unreliable and could lead to false diagnoses.
In a statement, the FDA said it was “especially concerned about delaying effective preventive treatments for women who show no symptoms, but who are still at increase risk of ovarian cancer.”
Ovarian cancer is the fifth-leading cause of cancer-related deaths among women. The National Cancer Institute estimates that this year more than 22,000 women between ages 35 and 74 will be diagnosed with the disease.
Those at highest risk are women who have reached menopause, those who have a family history of ovarian cancer, and women with the BRCA1 or BRCA2 genetic mutations.
When detected at its earliest stages, the five-year survival rate for ovarian cancer is 90 percent, according to the National Ovarian Cancer Coalition. Unfortunately, only about 20 percent of all cases are discovered at this stage. Nearly 15,000 women a year, die from the disease.
Related: New ovarian cancer drugs raise hope — but not for all
The most widely used screening test is called the CA 125, which measures the amount of the protein CA 125 in the blood.
While certain cancers, including ovarian cancer, may raise the blood level of CA 125, the test is far from foolproof. Many noncancerous conditions may also raise the level of CA 125, causing healthy women to undergo needless follow-up.
According to the American Cancer Society, no major medical or professional organization recommends the routine use of CA 125 blood tests to screen for ovarian cancer. Still, the test has been used extensively.
Based on the FDA’s review of available clinical data from ovarian screening trials and recommendations from health care professional societies and the US Preventive Services Task Force, the agency said, “available data do not demonstrate that currently available ovarian cancer screening tests are accurate and reliable in screening asymptomatic women for early ovarian cancer.”
The FDA’s announcement was praised by the Ovarian Cancer Research Fund Alliance, which has advocated such a move.
“From what we know anecdotally, in spite of the fact that CA 125 isn’t really meant to be used that way, many women who are concerned about the risk of ovarian cancer are getting the test every year,’’ said Sarah DeFeo, vice president of scientific affairs for the alliance. “In practice, lots of people are doing it.”
The CA 125 test has been around for many years, but one screening product, called ROCA, which adapted it into a series of tests, has been aggressively marketed since its approval for use in five states last year. An announcement from the company, Abcodia, said they planned to sell the ROCA Test nationwide by the end of 2016.
Key Statistics for Ovarian Cancer
The American Cancer Society estimates for ovarian cancer in the United States for 2020 are:
About 21,750 women will receive a new diagnosis of ovarian cancer.
About 13,940 women will die from ovarian cancer.
Ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. A woman's risk of getting ovarian cancer during her lifetime is about 1 in 78. Her lifetime chance of dying from ovarian cancer is about 1 in 108. (These statistics don’t count low malignant potential ovarian tumors.)
This cancer mainly develops in older women. About half of the women who are diagnosed with ovarian cancer are 63 years or older. It is more common in white women than African-American women.
The rate at which women are diagnosed with ovarian cancer has been slowly falling over the past 20 years.
https://www.cancer.org/cancer/ovarian-cancer/about/key-statistics.html
And now Aspira(Vermillion) does their own testing.
Important Information about OVA1®
OVA1 is an FDA-cleared blood test to help evaluate an ovarian mass for cancer prior to a planned surgery.
As of August 10, 2015, Quest Diagnostics will no longer provide OVA1 testing and will transition it to ASPiRA LABSTM. ASPiRA LABS will become the primary laboratory providing this test in the United States.
Should you have any questions about the transition of the OVA1 test, please call ASPiRA LABS at (844) ASPIRA1, visit aspiralab.com, or contact your Quest Diagnostics sales representative.
https://www.questdiagnostics.com/home/physicians/testing-services/by-test-name/ova1/
Ova 1
OVA1 Test is a qualitative serum test that combines the results of five immunoassays into a single numerical result. The tests include:
CA125 (increased in ovarian tumors)
Apolipoprotein A1 (decreased in ovarian tumors)
Beta-2 microglobulin (increased in ovarian tumors)
Transferrin (decreased in ovarian tumors)
Pre-albumin (decreased in ovarian tumors)
The tests are performed by Quest Diagnosics under an exclusive license agreement with Vermillion. CA125 is performed on the Roche Elecsys and the four other analytes are performed on the Siemens BNII. Quest submits the results of each analyte to Vermillion who uses proprietary software, called OvaCalc, to calculate an OVA 1 score, which ranges from 0 to10. A high probability of malignancy is defined as a score of 5.0 or greater in premenopausal women and 4.4 or greater in postmenopausal women.Only the OVA 1 score is reported to the ordering physician; not the results of the five component tests. The test costs about $650.
The OVA1 Test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. It can be used by a patient’s primary physician to decide if the patient should be referred to a gynecologist or a gynecologic oncologist.
The FDA has approved the use of OVA1 for women who meet the following criteria:
Over 18 years of age
Has an ovarian adnexal mass
Have surgery planned
Has not yet been referred to a gynecologic oncologist; and
Has not had cancer in the past five years
OVA1 test should not be ordered if clinical assessment or risk of malignancy warrants referral to a gynecological oncologist, since it does not provide additional information.
OVA1 score may be elevated in primary epithelial ovarian malignancies. Benign epithelial tumors, stromal tumors, germ cell tumors, or metastatic tumors may not be associated with an elevated score.
OVA1 is not intended to be a screening test for ovarian cancer and should not be ordered with CA125. It should not be used to determine whether a patient should proceed to surgery.
http://www.clinlabnavigator.com/ova-1.html
Do a Google Search on $VRML Vermillion's main product OVA1
To say this is fascinating is an understatement...
https://www.google.com/search?rlz=1C2CHBF_enUS856US860&sxsrf=ALeKk02AOBlBNQH-WfBFFYYCqr_gw7-SAg%3A1591603636692&source=hp&ei=tPHdXu26J_G1tgXGqKEI&q=ova1&oq=&gs_lcp=CgZwc3ktYWIQARgEMgcIIxDqAhAnMgcIIxDqAhAnMgcIIxDqAhAnMgcIIxDqAhAnMgcIIxDqAhAnMgcIIxDqAhAnMgcIIxDqAhAnMgcIIxDqAhAnMgcIIxDqAhAnMgcIIxDqAhAnUABYAGCWF2gBcAB4AIABAIgBAJIBAJgBAKoBB2d3cy13aXqwAQo&sclient=psy-ab
Hope something happens soon as I only got to the 19th on my calls! :)
Maybe it only took 10 years. Crazy!
https://www.contemporaryobgyn.net/article/ova1-test-more-accurate-ca-125-identifying-ovarian-cancer
Wonderfullllll
Well I think Joe is saying the deal is with Abbot Labs?
That would be something...
Monday news?????
Another test or the same test? Approved by the fda.
I’ve been following the money flow here, it seems like someone knows something that is for sure...
Possible?????
New test approved by fda
I see u asked Joe the question...
Teresa is some stranger on price ...something is cooking
Is that you on stocktwits?
If so I’m sending you my email!!!
I see the post on Stocktwits, is that what you are referring to?
News ?????? Is coming???
Now we are talking! I knew you had some inside scoop!
Yes or Drop a News Bombshell and wake up to $10 Dollars or more! LOL
Hopefully it bottoms out here and then comes back like a mofo!