|Re: cliff notes from the S1, rebought trader acct and avg'd up in IRA recently.|
I'm looking forward to the upcoming earnings call where the company will be providing the first 2020 revenue estimates for the PLA...I'm thinking this event just may wake a few analysts up to how cheap the stock is..we're looking at a $112 million mkt cap for a $6+ billion US market..the first coverage contract is just the initial salvo, the first of many....I'm not sure of the timing but an epic share grab will be coming.
A review of over 20,000 commercial PLA results indicated that 88% of reported PLA tests were negative and 12% were positive22. This combined with the finding in a 2017 study of 18,715 surgical biopsies of pigmented lesions showing that 83% of the lesions biopsied were either benign or mildly atypical lesions13, suggests that if the test has sufficient clinical performance to rule out melanoma (i.e. adequate sensitivity and negative predictive value), and treating clinicians use the test results as intended, it should result in significantly fewer unnecessary biopsies without compromising melanoma outcomes. Clinical performance is reviewed above. Here clinical decision making following the use of the test is reviewed.
In the Ferris longitudinal follow-up study mentioned above18 99% of the 330 PLA negative lesions were managed by dermatologists with surveillance. Three of the PLA- lesions that were biopsied in the follow up period were done so at the patient’s insistence. One PLA- lesion was simultaneously surgically biopsied (not the intended use of the test) and adhesive patch sampled and was diagnosed as melanoma in situ. There were zero missed melanomas found in the follow-up period. Of 51 PLA+ test results 100% were managed by dermatologists with a surgical biopsy. Nineteen (37%) of these cases were melanoma in situ / Stage 1 invasive melanomas with a thickness of <0.5 mm and demonstrating a NNB of 2.7 (51/19).
In an additional utility study by Ferris et al., 45 dermatologists who regularly evaluate pigmented lesions, assessed 60 cases containing dermatoscopic and lesional images (8 melanoma and 52 nevi with known pathologic concordance) with full patient and lesion history.18 The photographic/dermatoscopic analysis design of this study provided information nearly identical to the dermatologist’s primary clinical visual assessment used to make biopsy decisions and is therefore more relevant than typical decision impact studies that involve select case information review with and without a test result. Cases/images were initially presented without PLA results, and the dermatologists were asked to make a biopsy decision for suspicion of melanoma. The 60 cases were then shuffled and presented again, including the PLA test data. Again, dermatologists were asked to make a biopsy decision for suspicion of melanoma. Outcomes included changes in biopsy decisions, specificity, and sensitivity. Biopsy decisions increased from 750 to 1331. Assuming correctness of the reference diagnosis, the specificity of the biopsy decision increased by 1.8-fold with the PLA (32%-56%, p<0.001). The sensitivity also improved to approximately 99% (p=0.01) with the PLA, even with significant increases in specificity.
Most recently, a 2019 study by Ferris reviewed 12 month management decisions and outcomes for patients testing using the PLA.35 The study involved retrospective chart reviews of 734 lesions that were PLA(-) and a registry of 175 pigmented lesions tested using the PLA. Among the 734 PLA(-) lesions, 13 were biopsied within one year. Of these 13 biopsied lesions, 11 were nevi with various degrees of atypia, one was a basal cell carcinoma and one was a squamous cell carcinoma. None were melanomas. In the registry cohort 1433 of 1575 total lesions were PLA(-), and in follow-up only two had a surgical evaluation within a year. One of these had a scoop excision and as found to be a melanocytic nevus. The other was a squamous cell carcinoma removed by Mohs surgery. Of the 142 PLA(+) lesions in the registry cohort 96.5% were biopsied.
Beginning 2/10/20 status "F" will become status "A".
Subsequent massive Medicare revenues will go straight to DermTech beginning right in Q1 2020.
(See slides #5,9,10,14,21,24,27)
Proposed Status Legend:
D=Proposed under Development, not yet released for comment
C=Proposed LCD released for comment
E=Formal comment period has ended; comments now being considered
F=Final new/revised LCD has been issued for notice
A=Active policy, notice period complete and policy in effect
Notice Period Start Date
Notice Period End Date
Original Effective Date
For services performed on or after 02/10/2020
If what I suspect is true the Qualcomm founding family, large institutions, billionaire investors are already looking at the rest of the strong pipeline which retail is still in the dark about. Even now imo the stock remains underfollowed and significantly undervalued for what will be the SOC in skin cancer detection.
Companion & Complimentary Dx
Mantle Cell Lymphoma
------------------- "Opportunities multiply as they are seized" -- Sun Tzu circa 500 B.C. -------------------
| Reply to efbailey - Msg #2811165 - 01/13/2020 13:16|
cliff notes from the S1, rebought trader acct and avg'd up in IRA recently.
They are the only co offering a non-invasive genomics test for melanoma and recently got approved for Medicare reimbursement which goes into effect Feb 10th at $760 per test and has an NPV of 99%
Currently industry standard practice is surgical biopsy at avg cost of $947 and has a NPV of 83%
NPV measures the probability that a negative result is truly negative.
Patents that are good to 2029 plus others pending. Licensed in all 50 states. 6000 sf lab currently has a capacity of 50,000 test and they are currently adding automation to expand to 100,000 per yr. and with additional facility and investments play to scale to 1,000,000 per yr.
Currently there are over 3.5 million surgical biopsies per yr and over 95% are negative. DMTK's PLA test would eliminate unneeded biopsies at a cost savings of nearly $200 ea.
They have currently secured six contracts with major preferred provider networks, including MultiPlan Inc., FedMed, Inc., America’s Choice Provider Network, Three Rivers Provider Network, Inc., First Health Group Corp., and Midlands Choice, Inc. In addition, they have established contracts with Carefirst BCBS of Maryland, Inc. and Tricare West and submitted clinical and technology assessment packages to CareCore National, LLC dba eviCore healthcare, LLC, approximately 20 large payer partners, and a number of large commercial payers, including Aetna Inc., Cigna Corporation, UnitedHealthcare and Humana Inc., all of which are currently under review.
Company believes the total market opportunity for the PLA test in the US is $1.75- $3+ billion per yr. That's obviously down the road a bit but I can see them scaling to 100,000 capacity by end of 2020 which would put their revs at $76mil per yr. They did $2.4mil in 2018.
Current mkt cap is under $120mil, imo this could be a 10 bagger just off the PLA and Nevome test potential plus they have other products in the pipeline.