call conference quarter everyone, and to financial and results highlights. Bob, to our operating XXXX second discuss Thanks, welcome, our
Chief today Officer; our Operating on Hesterberg, me our Financial Levine, Al Chief Mitch Parker, Chief and Scientific Kalajian, Officer; Joining Accounting Officer; Lyndal our the Chief call Officer. are Tony
We the during at will available question-and-answer the end. all be session
call I'd excited truly by am how a off to express today's here. moment to start like taking I to be
As products. I've many may commercialization you majority from R&D career stages diagnostic know, development, companies my molecular of across of diagnostic for long spent vitro lab-developed both of test test and to in leading all
as led recognize patients member experiences oncology incredible These board over have a last I of continuum as believe tremendous we're to opportunity poised a years and tests. XX-plus the now the me other and for to complementary in high-value OncoCyte, care CEO. first, the of DetermaVu the impact with make
costs. interrogation information is proprietary uses system lung help gene in risky immune biological which an and and tool, response powerful associated system entirely to to decision-making detecting cancer The test immune DetermaVu that detection relevant changes We biopsies patients our expression will by could be provides clinical believe diagnosis. DetermaVu avoid new a and approach their method the complication cancer. in
unique unmet U.S. growing and large the need global a medical is this for and potential are convinced proposition market. commercial very and in truly approach The value a success I'm clear. enormous with
study of in estimates. for line DetermaVu? an June, original DetermaVu our time shifted we where So the do stand development had update provided our our Validation that In we from late CLIA
include precision test demonstrate reproducibility the specific real-world confirm lab as in CLIA setting. assay a R&D will CLIA a our to CLIA Validation we laboratory of the reminder, company's of performance protocols laboratory study so in staff clinical can tested samples equivalent that study XXX and accuracy, CLIA-validated conducted when the previously with As validation blood DetermaVu part and
our approach OncoCyte and through team committed in delay a advancing a had you what is our the can to tell I in and of hasn't available So to focused today commercially entire product. we wavered, while is biopsy terms DetermaVu belief that timing, liquid
Right the steps in our true was to transition our to all variables all through the we setting the use constraints a R&D associated final it's world. operation and environment that workflow work as needed an now over in validated hands-on-deck with with clinical clinical
some perspective. XX make What those an this is I'd team like and out can events, caused nuance, to transfer I've you went put R&D tell planned. I tests clinical from transition through environment to development been re-evaluate. over and actually very without career, technical something into that's share diagnostic that different in all what pause one it never all tech times. of our In to as fortunate Most a only my through setting to
I've to as working status process. to how of something informed, and on the track forward. time spend because current DetermaVu understand updating happened, move And to our the expect some we we're of is part get This importance I'd to what extra you the on learned of exactly the shareholders back program like keeping today
To standardization provide out reproducibility one from ensure R&D all a to ironing a setting clinical to sufficient the in place is transition patient little reporting background, details an actual for requires the results. of workflow
that in R&D In setting implementation we the than The need they research-use we industry CLIA consistently or my anticipate our typically reagents RUO. experience, what call that seen reality the time components setting. I've more in to test is companies are components face work RUO of in used and only, out the
we time the is to aspect are space variability for products, to be to clinical setting. lab composition see that An product those required these that our not of for new have manufacturers time, changes thus, accounted to QC our reagents RUO in to will note important in in and from
all this robust step I'd each was to clinical components right step point of development to to DetermaVu the out reproducible. is also system moment back during evaluate like the and and systematically pause, ensure
what and attest team been we're to the our July, evaluation all back track process. completing R&D personally on of the I've on get taking in doing of focused in Since they've role effort that incredible entire testing can us the the CEO early witnessed on
are we've what Here working for the details been exactly on.
steps, call of blood and separating we RNA process the There or it from workflow in starting extraction RNA, Sequencing, nucleic proteins acids Generation to sample. patient multiple extraction steps of it, consists as the in clean blood. are a from other multiple the Next NGS, the with found Our
the then Fisher the is gene sequencing reagents RNA the and call step chip further with preparation. the to is studio RNA gene placed a sample for the multiple for Once ready and library Purified prepped sequencing into This is loaded we be onto Thermo is system. interpretation. a library complete, and buffers
complex automation sound the may NGS refined been to the clinical it a few be become years we tests workflows bring with and over actually and we automated our benefiting have process, use, as that into very CLIA While setting. from will past like compatible
system we next-gen So platform is that sequencing of The let's the start last performing commercial the gene The DetermaVu. off use well. that implemented for incredibly and with year the confident we studio good platform remain reproducible, for launch remains news. best is this
ideal we the all industry, processes, for are requirement manufacturing our CLIA Importantly, it making as components setting. submission, of reagent FDA a manufactured reproducibility call demands for it good or the in under GMP
were issues over efforts the we our from last extraction variability from that reagents. lot-to-lot X weeks with key finding our RNA The encountering to is X R&D
work on will no we'll incoming with further that QC establish protocols to vendor test these to Now our we ensure cause, the impact notice reagents. as early we gain have our well closely of reproducibility isolated changes important to
the moving to RNA validation, Extracting essential pathway. development manner forward and to are keep we a on consistent required rapidly for from now experiments blood to the CLIA in is necessary the advancing reproducibility DetermaVu reproduce
Also development components. vendors, important that is that methods and a is We care. while a evaluated our all to completed automation now we issue, to process patient essential quantitative extraction and the went analytical with workflow we're working reagent also on ensure much back of for better and believe the we position are review thorough in reproducibility our note the
So all today. stand here's we said, with that where
Our our the original in to updated samples the time R&D retest built updated timeline workflow. is in
process solutions possible. as and samples go have along the have as possible efficiently to We identified expedite move ready to the and
original completed, the you this change plan, asked we original reinitiate be from months. have transparent validation Because steps X then to pushing will to we're Once These by of X out us CLIA timing the about in of more timeline process. additional many the the mean approximately process.
we So milestones to that specific will honor towards. are work some here request,
us the Over which work reagents, set system establish we full anticipate the test weeks, to completing been on have newly completed, archived the test lots. clinical from our allow with reproducibility. implemented our next we'll our begin of of to that's samples lot Once This our few validate will the on effort the extraction by full robustness to QC process. system validated sample selected new
on our lockdown into believe to performance work and methods, move fully full robustness date, we met is accuracy establishing and to done establish which us begin will we we complete team QX. X X process this the then confident will our of weeks, R&D within can When our Based Validation for we requirements parameters. testing the study, the we've we've will CLIA the
we Upon of CLIA clinical validation, completion and validation. these begin steps will our final
the we and XXX samples, to final As is samples ready collected commercially we previously need patient available. making confirmation prior news of and will phase, analyze approximately communicated study prospectively Notably, all the stand this that have will blinded to blood the to the final we this blood that expedite good step. this in DetermaVu complete be collected patient
working It's securing dossier. a real have Centers line shifted & delay CMS, in reimbursement line, while commercial review the Medicare in this or final is goal broad the of for aiming toward modest Services, for for highlight of our probably our Medicaid encountered to DetermaVu. we're most our hasn't The important reimbursement time target we that time availability
been toward As Validation Padma expert mentioned Sundar, goal diagnostics, Validation and access working to an fortunate recruit marketing studies. CLIA press today, in release with she Clinical market parallel our advancing actively and our we're has and in in in molecular this very
we believe today, is milestone. we ultimately of to an important most what assured As have our approach
who that with of a CMS review. For dossier are a process, submitting are number for must completed be steps the familiar CMS not before there those you of important
is reproducible First a test, working discussed and diligently as to deliver. we're which we already, foremost
studies. is a that details towards component the template science Another results DetermaVu progress the of our already I that And peer can manuscript publication. making we're share and underlying review
need will poised clinical are We've we immediately for clinical validation. the start study final also utility started planning to and acceptance complete after CMS we site the recruitment for
participate lives. that million a are key which of commercial already XX The represent to had number responses XX you I'd enthusiastically ready who we've enthusiastic opinion like for good plans, news leaders here health covered is that have with remind us. Moreover, we public and to
and encouraging, the from stable work believe the care are health revenue our our most to line see their can of aggressive lead is and improve test. execute for important that to These for an can outcomes improve us milestone extensive economics. still which diagnostic patient we plus potential CMS for generation They time prepare DetermaVu to opinions, review, reimbursement,
for me share in you I hope the such So time thank information. allowing process the to detail. it was helpful development
a plan. our team have are are some current execute great our Next, team while great key I at to for I'd critical skill impressed and to And personal very talent. like address needed sets we philosophy things. complement that and there with quest achieving to high-impact our to tactical people our I'm add fully experience the OncoCyte,
on been the the efforts building DetermaVu. commercial launch have of a of on these world-class support team shared to call I part last focused
President to Sundar Vice during Market we Padma mentioned recruited June As serve as Marketing Access. Senior the call, of successfully and
Affymetrix the broadest a possible patient step our on experience Padma advance forward DetermaVu to we Guardant population. and market her is and Having experience to from as great team the plans
markets efforts will molecular Her experience a preparing a and to biopsy liquid space and focus is paying tests with invaluable dividends. in developing as our for already diagnostic the marketing executive be
Dr. Vice clinical More to as leader and as brings programs studies. bolster team of Kim, Operations. essential President R&D in to of the our advance the recently, and Clinical we appointment our pathology, be operations clinical were a experience with that respected fortunate Dickinson Kim will
interrogation efforts inherent and into samples to team in to as adding trial cancer the our that clinical potential access areas management. we phase development in immune believe exploit clinical system and of lung us of Kim to approach. to to unmet to key our as delivering broaden She allow our fully sites other will need enter be the We will patients, the we
medical physicians a along talk very confident provide journey. community. the I'm bit Today, investment the the cure in years, to relevant to to let's future. research last ability OncoCyte's patient over So XX significant a for information in lung about continues evade the cancer the despite
to liquid us a focus Importantly, the understanding research has decision better points current industry's today of several underserved continuum that by biopsy landscape. and disease uncovered remain increasing and lead the critical
value centered this created around that therapy most The targeted answering has shareholder decision point what patient. for best the has today suited is been
important other room important in While tumor the and DNA best an in the today, DNA approach. remain companies this continuum Foundation Medicine, circulating suited is and one are several the Guardant decision the like point for OncoCyte significant critical decision and clinical for questions leaving earlier that market there cell-free unanswered
for opportunities journey patient market than currently players. unmet substantially The these along the served and by ones needs larger ct the the are cfDNA
along Our where shareholders. stakeholders team we incredible lung the and strategy continuum, ultimately points can to value our identified to has critical cancer decision bring patients,
OncoCyte. complement We DetermaVu forward of opportunities have the several and potential a for time bring line sight for to line revenues potential on
these conference how cancer patients management value shareholders. and to the look while our and following stakeholders continually strategic of increasing aspires I lung to OncoCyte insights improve to more season the to share share to of forward investor
While shareholders we DetermaVu their want understand these is initiatives believe early stages, are to I in the our beginning. that just
clear Our our is technically the and both executing deliver top financially. work is we R&D remains compelling hope though, product commercial on it's bold and that widespread to completing vision that and with Right DetermaVu adoption and a believe achievable now reimbursement. I priority and
molecular to to to years. incredibly evolution have diagnostics much in care, part more believe patient through the come. of there's clinical very exciting transformative teams in some the and shifts amazing been XX be past It's and I've I led of decision-making a been fortunate over
why And so be pleased I'm here OncoCyte. at to that's
Our I our this cusp call I pioneering and into confident on science clinical the being on too, done getting just that team hope way. of to you, benefit. is widespread DetermaVu across has committed that we're finish translated are am after line the
to of this Mitch review like our to for a call point, Mitch? the over I'd At turn Levine financials.
